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1. End of induction [18F]FDG PET is prognostic for progression-free survival and overall survival in follicular lymphoma patients enrolled in the FOLL12 trial

Author

Guerra, L, Chauvie, S, Fallanca, F, Bergesio, F, Marcheselli, L, Durmo, R, Peano, S, Franceschetto, A, Monaco, L, Barbieri, E, Ladetto, M, Musuraca, G, Tosi, P, Bianchi, B, Bolis, S, Pavone, V, Chiarenza, A, Arcari, A, Califano, C, Bari, A, Massaia, M, Conconi, A, Musto, P, Mannina, D, Roti, G, Galimberti, S, Gini, G, Falcinelli, F, Vitolo, U, Usai, S, Stefani, P, Ibatici, A, Liberati, A, Pennese, E, Perrone, T, Versari, A, Luminari, S, Guerra, Luca, Chauvie, Stephane, Fallanca, Federico, Bergesio, Fabrizio, Marcheselli, Luigi, Durmo, Rexhep, Peano, Simona, Franceschetto, Antonella, Monaco, Lavinia, Barbieri, Emiliano, Ladetto, Marco, Musuraca, Gerardo, Tosi, Patrizia, Bianchi, Benedetta, Bolis, Silvia Anna Maria, Pavone, Vincenzo, Chiarenza, Annalisa, Arcari, Annalisa, Califano, Catello, Bari, Alessia, Massaia, Massimo, Conconi, Annarita, Musto, Pellegrino, Mannina, Donato, Roti, Giovanni, Galimberti, Sara, Gini, Guido, Falcinelli, Flavio, Vitolo, Umberto, Usai, Sara Veronica, Stefani, Piero Maria, Ibatici, Adalberto, Liberati, Anna Marina, Pennese, Elsa, Perrone, Tommasina, Versari, Annibale, Luminari, Stefano, Guerra, L, Chauvie, S, Fallanca, F, Bergesio, F, Marcheselli, L, Durmo, R, Peano, S, Franceschetto, A, Monaco, L, Barbieri, E, Ladetto, M, Musuraca, G, Tosi, P, Bianchi, B, Bolis, S, Pavone, V, Chiarenza, A, Arcari, A, Califano, C, Bari, A, Massaia, M, Conconi, A, Musto, P, Mannina, D, Roti, G, Galimberti, S, Gini, G, Falcinelli, F, Vitolo, U, Usai, S, Stefani, P, Ibatici, A, Liberati, A, Pennese, E, Perrone, T, Versari, A, Luminari, S, Guerra, Luca, Chauvie, Stephane, Fallanca, Federico, Bergesio, Fabrizio, Marcheselli, Luigi, Durmo, Rexhep, Peano, Simona, Franceschetto, Antonella, Monaco, Lavinia, Barbieri, Emiliano, Ladetto, Marco, Musuraca, Gerardo, Tosi, Patrizia, Bianchi, Benedetta, Bolis, Silvia Anna Maria, Pavone, Vincenzo, Chiarenza, Annalisa, Arcari, Annalisa, Califano, Catello, Bari, Alessia, Massaia, Massimo, Conconi, Annarita, Musto, Pellegrino, Mannina, Donato, Roti, Giovanni, Galimberti, Sara, Gini, Guido, Falcinelli, Flavio, Vitolo, Umberto, Usai, Sara Veronica, Stefani, Piero Maria, Ibatici, Adalberto, Liberati, Anna Marina, Pennese, Elsa, Perrone, Tommasina, Versari, Annibale, and Luminari, Stefano

Abstract

Purpose: To evaluate the reliability of the Deauville score (DS) in therapy response assessment and to define the prognostic value of the metabolic response of end of induction (EOI) [18F]FDG PET (PET) in follicular lymphoma patients. Methods: Adult patients with untreated grade 1-3a FL/ stage II-IV enrolled in the multicentre, prospective, phase III FOLL12 trial (NCT02063685) were randomized to receive standard immunochemotherapy followed by rituximab maintenance (standard arm) versus standard immunochemotherapy followed by response-adapted post-induction management (experimental arm). Baseline and EOI PET were mandatory for the study. All PET scans were centralized on the WIDEN® platform and classified according to DS in a blind independent central review. DS1-3 was considered negative (CMR), whereas DS4-5 was considered positive (not CMR). The primary endpoint was PFS. The main secondary endpoint was overall survival (OS). Results: Overall, 807 follicular lymphoma patients-52% women, 89% stage III-IV disease, 40% with a high-risk FLIPI-2 score (3-5)-were enrolled in the study; 729 (90.4%) baseline and EOI PET were available for the analysis. EOI PET was positive (DS4-5) in 88/729 (12.1%) cases. Overall inter-reviewer agreement on PET pos/neg result was 0.92, while agreement on positive and negative cases was 0.77 and 0.94, respectively. The median follow-up was 69 months; 247 events were registered in the 5-yr follow-up, with a 5-yr PFS of 67% (95%CI: 63%-70%). The 5-yr PFS rate for PET neg (DS1-3) and PET pos (DS4-5) patients was 71% (95%CI: 67%-75%) and 36% (95%CI: 25%-46%), respectively, with HR 3.49 (95%CI: 2.57-4.72). Five-year PFS was worse as DS increased, with 74% (70%-78%), 58% (48%-67%; HR 1.71; p = 0.001)] and 36% (25%-46%; HR 3.88; p < 0.001) in DS1-2, DS3 and DS4-5, respectively. EOI PET maintained its prognostic value in both the standard and experimental arms. In the whole population, 5-yr OS was 94% (95%CI: 92%-96%), with 96% (95%CI: 94-97

Published
2024

2. Additional booster doses in patients with chronic lymphocytic leukemia induce humoral and cellular immune responses to SARS-CoV-2 similar to natural infection regardless ongoing treatments : A study by ERIC, the European Research Initiative on CLL

Author

Campanella, A., Capasso, A., Heltai, S., Taccetti, C., Albi, E., Herishanu, Y., Haggenburg, S., Chatzikonstantinou, T., Doubek, M., Kättström, Magdalena, Giannopoulos, K., Simkovic, M., Moreno, C., Massaia, M., Bumbea, H., Alshemmari, S., Ranghetti, P., Perotta, E., Martini, F., Sant'Antonio, E., Colia, M., Combi, C., Levi, S., Kater, A. P., Hazenberg, M., Nijhof, I. S., Hofsink, Q., Demosthenous, C., Kotaskova, J., Zaleska, J., Vrbacky, F., Raya, A. Mora, Bisogno, D., Tripoli, I. E., Popov, V. M., Roman, V., Stavroyianni, N., Karypidou, M., Scarano, E., Locatelli, M., Frenquelli, M., Scarfò, L., Stamatopoulos, K., Ghia, P., Campanella, A., Capasso, A., Heltai, S., Taccetti, C., Albi, E., Herishanu, Y., Haggenburg, S., Chatzikonstantinou, T., Doubek, M., Kättström, Magdalena, Giannopoulos, K., Simkovic, M., Moreno, C., Massaia, M., Bumbea, H., Alshemmari, S., Ranghetti, P., Perotta, E., Martini, F., Sant'Antonio, E., Colia, M., Combi, C., Levi, S., Kater, A. P., Hazenberg, M., Nijhof, I. S., Hofsink, Q., Demosthenous, C., Kotaskova, J., Zaleska, J., Vrbacky, F., Raya, A. Mora, Bisogno, D., Tripoli, I. E., Popov, V. M., Roman, V., Stavroyianni, N., Karypidou, M., Scarano, E., Locatelli, M., Frenquelli, M., Scarfò, L., Stamatopoulos, K., and Ghia, P.

Abstract

Profound immune dysregulation and impaired response to the SARS-CoV-2 vaccine put patients with chronic lymphocytic leukemia (CLL) at risk of severe COVID-19. We compared humoral memory and T-cell responses after booster dose vaccination or breakthrough infection. (Green) Quantitative determination of anti-Spike specific antibodies. Booster doses increased seroconversion rate and antibody titers in all patient categories, ultimately generating humoral responses similar to those observed in the postinfection cohort. In detail, humoral response with overscale median antibody titers arose in >80% of patients in watch and wait, off-therapy in remission, or under treatment with venetoclax single-agent. Anti-CD20 antibodies and active treatment with BTK inhibitors (BTKi) represent limiting factors of humoral response, still memory mounted in ~40% of cases following booster doses or infection. (Blue) Evaluation of SARS-CoV-2-specific T-cell responses. Number of T-cell functional activation markers documented in each patient. The vast majority of patients, including those seronegative, developed T-cell responses, qualitatively similar between treatment groups or between vaccination alone and infection cases. These data highlight the efficacy of booster doses in eliciting T-cell immunity independently of treatment status and support the use of additional vaccination boosters to stimulate humoral immunity in patients on active CLL-directed treatments., The project was supported in part by Fondazione Veronesi (ID 1852164), Janssen (IBR-I-20-EMEA-014-V01/54179060CLL4024; NOPRODCLL4001), and MH CZ—DRO (FNBr, 65269705).

Published
2024
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4. Additional booster doses in patients with chronic lymphocytic leukemia induce humoral and cellular immune responses to SARS‐CoV‐2 similar to natural infection regardless ongoing treatments: A study by ERIC, the European Research Initiative on CLL

Author

Campanella, A., primary, Capasso, A., additional, Heltai, S., additional, Taccetti, C., additional, Albi, E., additional, Herishanu, Y., additional, Haggenburg, S., additional, Chatzikonstantinou, T., additional, Doubek, M., additional, Kättström, M., additional, Giannopoulos, K., additional, Simkovic, M., additional, Moreno, C., additional, Massaia, M., additional, Bumbea, H., additional, Alshemmari, S., additional, Ranghetti, P., additional, Perotta, E., additional, Martini, F., additional, Sant'Antonio, E., additional, Colia, M., additional, Combi, C., additional, Levi, S., additional, Kater, A. P., additional, Hazenberg, M., additional, Nijhof, I. S., additional, Hofsink, Q., additional, Demosthenous, C., additional, Kotaskova, J., additional, Zaleska, J., additional, Vrbacky, F., additional, Raya, A. Mora, additional, Bisogno, D., additional, Tripoli, I. E., additional, Popov, V. M., additional, Roman, V., additional, Stavroyianni, N., additional, Karypidou, M., additional, Scarano, E., additional, Locatelli, M., additional, Frenquelli, M., additional, Scarfò, L., additional, Stamatopoulos, K., additional, and Ghia, P., additional

Published
2024
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5. SARS-CoV-2 infection in patients with chronic lymphocytic leukemia: The Italian Hematology Alliance on COVID-19 cohort

Author

Merli, M, Ferrarini, I, Merli, F, Busca, A, Mina, R, Falini, B, Bruna, R, Cairoli, R, Marchetti, M, Romano, A, Cavo, M, Arcaini, L, Trentin, L, Cattaneo, C, Derenzini, E, Fracchiolla, N, Marchesi, F, Scattolin, A, Billio, A, Bocchia, M, Massaia, M, Gambacorti-Passerini, C, Mauro, F, Gentile, M, Mohamed, S, Della Porta, M, Coviello, E, Cilloni, D, Visani, G, Federici, A, Tisi, M, Cudillo, L, Galimberti, S, Gherlinzoni, F, Pagano, L, Guidetti, A, Bertu, L, Corradini, P, Passamonti, F, Visco, C, Merli M., Ferrarini I., Merli F., Busca A., Mina R., Falini B., Bruna R., Cairoli R., Marchetti M., Romano A., Cavo M., Arcaini L., Trentin L., Cattaneo C., Derenzini E., Fracchiolla N. S., Marchesi F., Scattolin A., Billio A., Bocchia M., Massaia M., Gambacorti-Passerini C., Mauro F. R., Gentile M., Mohamed S., Della Porta M. G., Coviello E., Cilloni D., Visani G., Federici A. B., Tisi M. C., Cudillo L., Galimberti S., Gherlinzoni F., Pagano L., Guidetti A., Bertu L., Corradini P., Passamonti F., Visco C., Merli, M, Ferrarini, I, Merli, F, Busca, A, Mina, R, Falini, B, Bruna, R, Cairoli, R, Marchetti, M, Romano, A, Cavo, M, Arcaini, L, Trentin, L, Cattaneo, C, Derenzini, E, Fracchiolla, N, Marchesi, F, Scattolin, A, Billio, A, Bocchia, M, Massaia, M, Gambacorti-Passerini, C, Mauro, F, Gentile, M, Mohamed, S, Della Porta, M, Coviello, E, Cilloni, D, Visani, G, Federici, A, Tisi, M, Cudillo, L, Galimberti, S, Gherlinzoni, F, Pagano, L, Guidetti, A, Bertu, L, Corradini, P, Passamonti, F, Visco, C, Merli M., Ferrarini I., Merli F., Busca A., Mina R., Falini B., Bruna R., Cairoli R., Marchetti M., Romano A., Cavo M., Arcaini L., Trentin L., Cattaneo C., Derenzini E., Fracchiolla N. S., Marchesi F., Scattolin A., Billio A., Bocchia M., Massaia M., Gambacorti-Passerini C., Mauro F. R., Gentile M., Mohamed S., Della Porta M. G., Coviello E., Cilloni D., Visani G., Federici A. B., Tisi M. C., Cudillo L., Galimberti S., Gherlinzoni F., Pagano L., Guidetti A., Bertu L., Corradini P., Passamonti F., and Visco C.

Abstract

COVID-19, the disease caused by SARS-CoV-2, is still afflicting thousands of people across the globe. Few studies on COVID-19 in chronic lymphocytic leukemia (CLL) are available. Here, we analyzed data from the CLL cohort of the Italian Hematology Alliance on COVID-19 (NCT04352556), which included 256 CLL patients enrolled between 25 February 2020 and 1 February 2021. Median age was 70 years (range 38–94) with male preponderance (60.1%). Approximately half of patients (n = 127) had received at least one line of therapy for CLL, including 108 (83.7%) who were on active treatment at the time of COVID-19 or received their last therapy within 12 months. Most patients (230/256, 89.9%) were symptomatic at COVID-19 diagnosis and the majority required hospitalization (n = 176). Overall, after a median follow-up of 42 days (IQR 24–96), case fatality rate was 30.1%, and it was 37.5% and 24.4% in the first (25 February 2020–22 June 2020) and second wave (23 June 2020–1 February 2021), respectively (p = 0.03). At multivariate analysis, male sex (HR 1.82, 95% CI 1.03–3.24, p = 0.04), age over than 70 years (HR 2.23, 95% CI 1.23–4.05, p = 0.01), any treatment for CLL given in the last 12 months (HR 1.72, 95% CI 1.04–2.84, p = 0.04) and COVID-19 severity (severe: HR 5.66, 95% CI 2.62–12.33, p < 0.0001; critical: HR 15.99, 95% CI 6.93–36.90, p < 0.0001) were independently associated with poor survival. In summary, we report a dismal COVID-related outcome in a significant fraction of CLL patients, that can be nicely predicted by clinical parameters.

Published
2023

6. PB0316 Bortezomib for the Treatment of Multi-Refractory Immune-Mediated Thrombotic Thrombocytopenic Purpura: An Italian Multicenter Survey

Author

Giannotta, J., primary, Artoni, A., additional, Mancini, I., additional, Truma, A., additional, Agosti, P., additional, Carpenedo, M., additional, Mancini, G., additional, Molteni, A., additional, Rinaldi, E., additional, Bocchia, M., additional, Napolitano, M., additional, Prezioso, L., additional, Cuccaro, A., additional, Scarpa, E., additional, Grimaldi, D., additional, Massaia, M., additional, and Peyvandi, F., additional

Published
2023
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7. Secondary infections worsen the outcome of COVID-19 in patients with hematological malignancies: A report from the ITA-HEMA-COV

Author

Zappasodi, P, Cattaneo, C, Ferretti, V, Mina, R, Ferreri, A, Merli, F, Oberti, M, Krampera, M, Romano, A, Zerbi, C, Ferrari, J, Cavo, M, Marco Salvini, M, Bertù, L, Fracchiolla, N, Marchesi, F, Massaia, M, Marasco, V, Cairoli, R, Scattolin, A, Vannucchi, A, Gambacorti-Passerini, C, Musto, P, Gherlinzoni, F, Cuneo, A, Pinto, A, Trentin, L, Bocchia, M, Galimberti, Coviello, E, Mc, Morotti, A, Falini, B, Turrin, M, Tafuri, A, Billio, A, Gentile, M, Lemoli, M, 37, Venditti, A, Della Porta, M, Lanza, F, Rigacci, L, Tosi, P, Mohamed, S, Corso, A, Luppi, M, Giuliani, N, Busca, A, Pagano, L, Bruno, R, Grossi, P, Corradini, P, Passamonti, F, Arcaini, L, Zappasodi P, Cattaneo C, Ferretti V, Mina R, Ferreri AJ, Merli F, Oberti M, Krampera M, Romano A, Zerbi C, Ferrari J, Cavo M, Marco Salvini M, Bertù L, Fracchiolla N, Marchesi F, Massaia M, Marasco V, Cairoli R, Scattolin AM, Vannucchi AM, Gambacorti-Passerini C, Musto P, Gherlinzoni F, Cuneo A, Pinto A, Trentin L, Bocchia M, Coviello E, MC, Morotti A, Falini B, Turrin M, Tafuri A, Billio A, Gentile M, Lemoli M, Venditti A, Della Porta M, Lanza F, Rigacci L, Tosi P, Mohamed S, Corso A, Luppi M, Giuliani N, Busca A, Pagano L, Bruno R, Grossi P, Corradini P, Passamonti F, Arcaini L., Zappasodi, P, Cattaneo, C, Ferretti, V, Mina, R, Ferreri, A, Merli, F, Oberti, M, Krampera, M, Romano, A, Zerbi, C, Ferrari, J, Cavo, M, Marco Salvini, M, Bertù, L, Fracchiolla, N, Marchesi, F, Massaia, M, Marasco, V, Cairoli, R, Scattolin, A, Vannucchi, A, Gambacorti-Passerini, C, Musto, P, Gherlinzoni, F, Cuneo, A, Pinto, A, Trentin, L, Bocchia, M, Galimberti, Coviello, E, Mc, Morotti, A, Falini, B, Turrin, M, Tafuri, A, Billio, A, Gentile, M, Lemoli, M, 37, Venditti, A, Della Porta, M, Lanza, F, Rigacci, L, Tosi, P, Mohamed, S, Corso, A, Luppi, M, Giuliani, N, Busca, A, Pagano, L, Bruno, R, Grossi, P, Corradini, P, Passamonti, F, Arcaini, L, Zappasodi P, Cattaneo C, Ferretti V, Mina R, Ferreri AJ, Merli F, Oberti M, Krampera M, Romano A, Zerbi C, Ferrari J, Cavo M, Marco Salvini M, Bertù L, Fracchiolla N, Marchesi F, Massaia M, Marasco V, Cairoli R, Scattolin AM, Vannucchi AM, Gambacorti-Passerini C, Musto P, Gherlinzoni F, Cuneo A, Pinto A, Trentin L, Bocchia M, Coviello E, MC, Morotti A, Falini B, Turrin M, Tafuri A, Billio A, Gentile M, Lemoli M, Venditti A, Della Porta M, Lanza F, Rigacci L, Tosi P, Mohamed S, Corso A, Luppi M, Giuliani N, Busca A, Pagano L, Bruno R, Grossi P, Corradini P, Passamonti F, and Arcaini L.

Abstract

The impact of secondary infections (SI) on COVID-19 outcome in patients with hematological malignancies (HM) is scarcely documented. To evaluate incidence, clinical characteristics, and outcome of SI, we analyzed the microbiologically documented SI in a large multicenter cohort of adult HM patients with COVID-19. Among 1741 HM patients with COVID-19, 134 (7.7%) had 185 SI, with a 1-month cumulative incidence of 5%. Median time between COVID-19 diagnosis and SI was 16 days (IQR: 5–36). Acute myeloid leukemia (AML) and lymphoma/plasma cell neoplasms (PCN) were more frequent diagnoses in SI patients compared to patients without SI (AML: 14.9% vs. 7.1%; lymphoma/PCN 71.7% vs. 65.3%). Patients with SI were older (median age 70 vs. 66 years, p = 0.002), with more comorbidities (median Charlson Comorbidity Index 5 vs. 4, p < 0.001), higher frequency of critical COVID-19 (19.5% vs. 11.5%, p = 0.046), and more frequently not in complete remission (75% vs. 64.7% p = 0.024). Blood and bronchoalveolar lavage were the main sites of isolation for SI. Etiology of infections was bacterial in 80% (n = 148) of cases, mycotic in 9.7% (n = 18) and viral in 10.3% (n = 19); polymicrobial infections were observed in 24 patients (18%). Escherichia coli represented most of Gram-negative isolates (18.9%), while coagulase-negative Staphylococci were the most frequent among Gram-positive (14.2%). The 30-day mortality of patients with SI was higher when compared to patients without SI (69% vs. 15%, p < 0.001). The occurrence of SI worsened COVID-19 outcome in HM patients. Timely diagnosis and adequate management should be considered to improve their prognosis.

Published
2022

8. Lack of efficacy of convalescent plasma in COVID-19 patients with concomitant hematological malignancies: An Italian retrospective study

Author

Lanza, F, Monaco, F, Ciceri, F, Cairoli, R, Sacchi, M, Guidetti, A, Marchetti, M, Massaia, M, Arcaini, L, Krampera, M, Mohamed, S, Gherlinzoni, F, Mecucci, C, Gentile, M, Romano, I, Venditti, A, Ruggeri, M, Ferrero, D, Coviello, E, Fabbri, E, Corradini, P, Passamonti, F, Lanza F, Monaco F, Ciceri F, Cairoli R, Sacchi MV, Guidetti A, Marchetti M, Massaia M, Arcaini L, Krampera M, Mohamed S, Gherlinzoni F, Mecucci C, Gentile M, Romano I, Venditti A, Ruggeri M, Ferrero D, Coviello E, Fabbri E, Corradini P, Passamonti F., Lanza, F, Monaco, F, Ciceri, F, Cairoli, R, Sacchi, M, Guidetti, A, Marchetti, M, Massaia, M, Arcaini, L, Krampera, M, Mohamed, S, Gherlinzoni, F, Mecucci, C, Gentile, M, Romano, I, Venditti, A, Ruggeri, M, Ferrero, D, Coviello, E, Fabbri, E, Corradini, P, Passamonti, F, Lanza F, Monaco F, Ciceri F, Cairoli R, Sacchi MV, Guidetti A, Marchetti M, Massaia M, Arcaini L, Krampera M, Mohamed S, Gherlinzoni F, Mecucci C, Gentile M, Romano I, Venditti A, Ruggeri M, Ferrero D, Coviello E, Fabbri E, Corradini P, and Passamonti F.

Abstract

A multicenter retrospective study was designed to assess clinical outcome of COVID-19 in patients with hematological malignancies (HM) following treatment with anti-SARS-CoV-2 convalescent plasma (CP) or standard of care therapy. To this aim, a propensity score matching was used to assess the role of non-randomized administration of CP in this high-risk cohort of patients from the Italian Hematology Alliance on COVID-19 (ITA-HEMA-COV) project, now including 2049 untreated control patients. We investigated 30- and 90-day mortality, rate of admission to intensive care unit, proportion of patients requiring mechanical ventilatory support, hospitalization time, and SARS-CoV-2 clearance in 79 CP recipients and compared results with 158 propensity score-matched controls. Results indicated a lack of efficacy of CP in the study group compared with the untreated group, thus confirming the negative results obtained from randomized studies in immunocompetent individuals with COVID-19. In conclusion, this retrospective analysis did not meet the primary and secondary end points in any category of immunocompromized patients affected by HM.

Published
2022

9. A prognostic model for patients with lymphoma and COVID-19: a multicentre cohort study

Author

Visco, C, Marcheselli, L, Mina, R, Sassone, M, Guidetti, A, Penna, D, Cattaneo, C, Bonuomo, V, Busca, A, Ferreri, A, Bruna, R, Petrucci, L, Cairoli, R, Salvini, M, Bertu, L, Ladetto, M, Pilerci, S, Pinto, A, Ramadan, S, Marchesi, F, Cavo, M, Arcaini, L, Coviello, E, Romano, A, Musto, P, Massaia, M, Fracchiolla, N, Marchetti, M, Scattolin, A, Tisi, M, Cuneo, A, Porta, M, Trentin, L, Turrini, M, Gherlinzoni, F, Tafuri, A, Galimberti, S, Bocchia, M, Cardinali, V, Cilloni, D, Corso, A, Armiento, D, Rigacci, L, La Barbera, E, Gambacorti Passerini, C, Visani, G, Vallisa, D, Venditti, A, Selleri, C, Conconi, A, Tosi, P, Lanza, F, Candoni, A, Krampera, M, Corradini, P, Passamonti, F, Merli, F, Visco C., Marcheselli L., Mina R., Sassone M., Guidetti A., Penna D., Cattaneo C., Bonuomo V., Busca A., Ferreri A. J. M., Bruna R., Petrucci L., Cairoli R., Salvini M., Bertu L., Ladetto M., Pilerci S., Pinto A., Ramadan S., Marchesi F., Cavo M., Arcaini L., Coviello E., Romano A., Musto P., Massaia M., Fracchiolla N., Marchetti M., Scattolin A., Tisi M. C., Cuneo A., Porta M. D., Trentin L., Turrini M., Gherlinzoni F., Tafuri A., Galimberti S., Bocchia M., Cardinali V., Cilloni D., Corso A., Armiento D., Rigacci L., La Barbera E. O., Gambacorti Passerini C., Visani G., Vallisa D., Venditti A., Selleri C., Conconi A., Tosi P., Lanza F., Candoni A., Krampera M., Corradini P., Passamonti F., Merli F., Visco, C, Marcheselli, L, Mina, R, Sassone, M, Guidetti, A, Penna, D, Cattaneo, C, Bonuomo, V, Busca, A, Ferreri, A, Bruna, R, Petrucci, L, Cairoli, R, Salvini, M, Bertu, L, Ladetto, M, Pilerci, S, Pinto, A, Ramadan, S, Marchesi, F, Cavo, M, Arcaini, L, Coviello, E, Romano, A, Musto, P, Massaia, M, Fracchiolla, N, Marchetti, M, Scattolin, A, Tisi, M, Cuneo, A, Porta, M, Trentin, L, Turrini, M, Gherlinzoni, F, Tafuri, A, Galimberti, S, Bocchia, M, Cardinali, V, Cilloni, D, Corso, A, Armiento, D, Rigacci, L, La Barbera, E, Gambacorti Passerini, C, Visani, G, Vallisa, D, Venditti, A, Selleri, C, Conconi, A, Tosi, P, Lanza, F, Candoni, A, Krampera, M, Corradini, P, Passamonti, F, Merli, F, Visco C., Marcheselli L., Mina R., Sassone M., Guidetti A., Penna D., Cattaneo C., Bonuomo V., Busca A., Ferreri A. J. M., Bruna R., Petrucci L., Cairoli R., Salvini M., Bertu L., Ladetto M., Pilerci S., Pinto A., Ramadan S., Marchesi F., Cavo M., Arcaini L., Coviello E., Romano A., Musto P., Massaia M., Fracchiolla N., Marchetti M., Scattolin A., Tisi M. C., Cuneo A., Porta M. D., Trentin L., Turrini M., Gherlinzoni F., Tafuri A., Galimberti S., Bocchia M., Cardinali V., Cilloni D., Corso A., Armiento D., Rigacci L., La Barbera E. O., Gambacorti Passerini C., Visani G., Vallisa D., Venditti A., Selleri C., Conconi A., Tosi P., Lanza F., Candoni A., Krampera M., Corradini P., Passamonti F., and Merli F.

Abstract

Lymphoma represents a heterogeneous hematological malignancy (HM), which is characterized by severe immunosuppression. Patients diagnosed of coronavirus disease 2019 (COVID-19) during the course of HM have been described to have poor outcome, with only few reports specifically addressing lymphoma patients. Here, we investigated the clinical behavior and clinical parameters of a large multicenter cohort of adult patients with different lymphoma subtypes, with the aim of identifying predictors of death. The study included 856 patients, of whom 619 were enrolled prospectively in a 1-year frame and were followed-up for a median of 66 days (range 1-395). Patients were managed as outpatient (not-admitted cohort, n 5 388) or required hospitalization (n 5 468), and median age was 63 years (range 19-94). Overall, the 30- and 100-days mortality was 13% (95% confidence interval (CI), 11% to 15%) and 23% (95% CI, 20% to 27%), respectively. Antilymphoma treatment, including anti-CD20 containing regimens, did not impact survival. Patients with Hodgkin’s lymphoma had the more favorable survival, but this was partly related to significantly younger age. The time interval between lymphoma diagnosis and COVID-19 was inversely related to mortality. Multivariable analysis recognized 4 easy-to-use factors (age, gender, lymphocyte, and platelet count) that were associated with risk of death, both in the admitted and in the not-admitted cohort (HR 3.79 and 8.85 for the intermediate- and high-risk group, respectively). Overall, our study shows that patients should not be deprived of the best available treatment of their underlying disease and indicates which patients are at higher risk of death. This study was registered with ClinicalTrials.gov, NCT04352556.

Published
2022

10. Secondary infections worsen the outcome of COVID-19 in patients with hematological malignancies: A report from the ITA-HEMA-COV

Author

Zappasodi P, Cattaneo C, Ferretti V, Mina R, Ferreri AJ, Merli F, Oberti M, Krampera M, Romano A, Zerbi C, Ferrari J, Cavo M, Marco Salvini M, Bertù L, Fracchiolla N, Marchesi F, Massaia M, Marasco V, Cairoli R, Scattolin AM, Vannucchi AM, Gambacorti-Passerini C, Musto P, Gherlinzoni F, Cuneo A, Pinto A, Trentin L, Bocchia M, Galimberti, Coviello E, Morotti A, Falini B, Turrin M, Tafuri A, Billio A, Gentile M, Lemoli M, Venditti A, Della Porta M, Lanza F, Rigacci L, Tosi P, Mohamed S, Corso A, Luppi M, Giuliani N, Busca A, Pagano L, Bruno R, Grossi P, Corradini P, Passamonti F, Arcaini L., Zappasodi, P, Cattaneo, C, Ferretti, V, Mina, R, Ferreri, A, Merli, F, Oberti, M, Krampera, M, Romano, A, Zerbi, C, Ferrari, J, Cavo, M, Marco Salvini, M, Bertù, L, Fracchiolla, N, Marchesi, F, Massaia, M, Marasco, V, Cairoli, R, Scattolin, A, Vannucchi, A, Gambacorti-Passerini, C, Musto, P, Gherlinzoni, F, Cuneo, A, Pinto, A, Trentin, L, Bocchia, M, Galimberti, Coviello, E, Mc, Morotti, A, Falini, B, Turrin, M, Tafuri, A, Billio, A, Gentile, M, Lemoli, M, Venditti, A, Della Porta, M, Lanza, F, Rigacci, L, Tosi, P, Mohamed, S, Corso, A, Luppi, M, Giuliani, N, Busca, A, Pagano, L, Bruno, R, Grossi, P, Corradini, P, Passamonti, F, Arcaini, L, Zappasodi, Patrizia, Cattaneo, Chiara, Ferretti, Virginia Valeria, Mina, Roberto, Ferreri, Andrés José María, Merli, Francesco, Oberti, Margherita, Krampera, Mauro, Romano, Alessandra, Zerbi, Caterina, Ferrari, Jacqueline, Cavo, Michele, Salvini, Marco, Bertù, Lorenza, Fracchiolla, Nicola Stefano, Marchesi, Francesco, Massaia, Massimo, Marasco, Vincenzo, Cairoli, Roberto, Scattolin, Anna Maria, Vannucchi, Alessandro Maria, Gambacorti-Passerini, Carlo, Musto, Pellegrino, Gherlinzoni, Filippo, Cuneo, Antonio, Pinto, Antonello, Trentin, Livio, Bocchia, Monica, Galimberti, Sara, Coviello, Elisa, Tisi, Maria Chiara, Morotti, Alessandro, Falini, Brunangelo, Turrini, Mauro, Tafuri, Agostino, Billio, Atto, Gentile, Massimo, Lemoli, Roberto Massimo, Venditti, Adriano, Della Porta, Matteo Giovanni, Lanza, Francesco, Rigacci, Luigi, Tosi, Patrizia, Mohamed, Sara, Corso, Alessandro, Luppi, Mario, Giuliani, Nicola, Busca, Alessandro, Pagano, Livio, Bruno, Raffaele, Grossi, Paolo Antonio, Corradini, Paolo, Passamonti, Francesco, and Arcaini, Luca

Subjects
Cancer Research, Lymphoma, Coinfection, COVID-19, Hematology, General Medicine, Settore MED/15, hematological malignancie, secondary infections, Settore MED/15 - MALATTIE DEL SANGUE, COVID-19 Testing, Oncology, Hematologic Neoplasms, secondary infection, outcome, Humans, hematological malignancies, Aged
Abstract

The impact of secondary infections (SI) on COVID-19 outcome in patients with hematological malignancies (HM) is scarcely documented. To evaluate incidence, clinical characteristics, and outcome of SI, we analyzed the microbiologically documented SI in a large multicenter cohort of adult HM patients with COVID-19. Among 1741 HM patients with COVID-19, 134 (7.7%) had 185 SI, with a 1-month cumulative incidence of 5%. Median time between COVID-19 diagnosis and SI was 16 days (IQR: 5-36). Acute myeloid leukemia (AML) and lymphoma/plasma cell neoplasms (PCN) were more frequent diagnoses in SI patients compared to patients without SI (AML: 14.9% vs. 7.1%; lymphoma/PCN 71.7% vs. 65.3%). Patients with SI were older (median age 70 vs. 66 years, p = 0.002), with more comorbidities (median Charlson Comorbidity Index 5 vs. 4, p < 0.001), higher frequency of critical COVID-19 (19.5% vs. 11.5%, p = 0.046), and more frequently not in complete remission (75% vs. 64.7% p = 0.024). Blood and bronchoalveolar lavage were the main sites of isolation for SI. Etiology of infections was bacterial in 80% (n = 148) of cases, mycotic in 9.7% (n = 18) and viral in 10.3% (n = 19); polymicrobial infections were observed in 24 patients (18%). Escherichia coli represented most of Gram-negative isolates (18.9%), while coagulase-negative Staphylococci were the most frequent among Gram-positive (14.2%). The 30-day mortality of patients with SI was higher when compared to patients without SI (69% vs. 15%, p < 0.001). The occurrence of SI worsened COVID-19 outcome in HM patients. Timely diagnosis and adequate management should be considered to improve their prognosis.

Published
2022

11. COVID-19 elicits an impaired antibody response against SARS-CoV-2 in patients with haematological malignancies

Author

Passamonti, F, Romano, A, Salvini, M, Merli, F, Porta, M, Bruna, R, Coviello, E, Romano, I, Cairoli, R, Lemoli, R, Farina, F, Venditti, A, Busca, A, Ladetto, M, Massaia, M, Pinto, A, Arcaini, L, Tafuri, A, Marchesi, F, Fracchiolla, N, Bocchia, M, Armiento, D, Candoni, A, Krampera, M, Luppi, M, Cardinali, V, Galimberti, S, Cattaneo, C, La Barbera, E, Mina, R, Lanza, F, Visani, G, Musto, P, Petrucci, L, Zaja, F, Grossi, P, Bertu, L, Pagano, L, Corradini, P, Derenzini, E, Marchetti, M, Scattolin, A, Corso, A, Tosi, P, Gherlinzoni, F, Gambacorti Passerini, C, Cavo, M, Fava, C, Turrini, M, Visco, C, Zappasodi, P, Merli, M, Mora, B, Vannucchi, A, Passamonti F., Romano A., Salvini M., Merli F., Porta M. G. D., Bruna R., Coviello E., Romano I., Cairoli R., Lemoli R., Farina F., Venditti A., Busca A., Ladetto M., Massaia M., Pinto A., Arcaini L., Tafuri A., Marchesi F., Fracchiolla N., Bocchia M., Armiento D., Candoni A., Krampera M., Luppi M., Cardinali V., Galimberti S., Cattaneo C., La Barbera E. O., Mina R., Lanza F., Visani G., Musto P., Petrucci L., Zaja F., Grossi P. A., Bertu L., Pagano L., Corradini P., Derenzini E., Marchetti M., Scattolin A. M., Corso A., Tosi P., Gherlinzoni F., Gambacorti Passerini C., Cavo M., Fava C., Turrini M., Visco C., Zappasodi P., Merli M., Mora B., Vannucchi A. M., Passamonti, F, Romano, A, Salvini, M, Merli, F, Porta, M, Bruna, R, Coviello, E, Romano, I, Cairoli, R, Lemoli, R, Farina, F, Venditti, A, Busca, A, Ladetto, M, Massaia, M, Pinto, A, Arcaini, L, Tafuri, A, Marchesi, F, Fracchiolla, N, Bocchia, M, Armiento, D, Candoni, A, Krampera, M, Luppi, M, Cardinali, V, Galimberti, S, Cattaneo, C, La Barbera, E, Mina, R, Lanza, F, Visani, G, Musto, P, Petrucci, L, Zaja, F, Grossi, P, Bertu, L, Pagano, L, Corradini, P, Derenzini, E, Marchetti, M, Scattolin, A, Corso, A, Tosi, P, Gherlinzoni, F, Gambacorti Passerini, C, Cavo, M, Fava, C, Turrini, M, Visco, C, Zappasodi, P, Merli, M, Mora, B, Vannucchi, A, Passamonti F., Romano A., Salvini M., Merli F., Porta M. G. D., Bruna R., Coviello E., Romano I., Cairoli R., Lemoli R., Farina F., Venditti A., Busca A., Ladetto M., Massaia M., Pinto A., Arcaini L., Tafuri A., Marchesi F., Fracchiolla N., Bocchia M., Armiento D., Candoni A., Krampera M., Luppi M., Cardinali V., Galimberti S., Cattaneo C., La Barbera E. O., Mina R., Lanza F., Visani G., Musto P., Petrucci L., Zaja F., Grossi P. A., Bertu L., Pagano L., Corradini P., Derenzini E., Marchetti M., Scattolin A. M., Corso A., Tosi P., Gherlinzoni F., Gambacorti Passerini C., Cavo M., Fava C., Turrini M., Visco C., Zappasodi P., Merli M., Mora B., and Vannucchi A. M.

Abstract

COVID-19 is associated with high mortality in patients with haematological malignancies (HM) and rate of seroconversion is unknown. The ITA-HEMA-COV project (NCT04352556) investigated patterns of seroconversion for SARS-CoV-2 IgG in patients with HMs. A total of 237 patients, SARS-CoV-2 PCR-positive with at least one SARS-CoV-2 IgG test performed during their care, entered the analysis. Among these, 62 (26·2%) had myeloid, 121 (51·1%) lymphoid and 54 (22·8%) plasma cell neoplasms. Overall, 69% of patients (164 of 237) had detectable IgG SARS-CoV-2 serum antibodies. Serologically negative patients (31%, 73 of 237) were evenly distributed across patients with myeloid, lymphoid and plasma cell neoplasms. In the multivariable logistic regression, chemoimmunotherapy [odds ratio (OR), 3·42; 95% confidence interval (CI), 1·04–11·21; P = 0·04] was associated with a lower rate of seroconversion. This effect did not decline after 180 days from treatment withdrawal (OR, 0·35; 95% CI: 0·11–1·13; P = 0·08). This study demonstrates a low rate of seroconversion in HM patients and indicates that treatment-mediated immune dysfunction is the main driver. As a consequence, we expect a low rate of seroconversion after vaccination and thus we suggest testing the efficacy of seroconversion in HM patients.

Published
2021

12. P1098: OUTCOME OF FOLLICULAR LYMPHOMA PATIENTS IN MAINTENANCE TREATMENT WITH ANTICD20 MONOCLONAL ANTIBODIES IN SARS-COV2 ERA: RESULTS FROM A MULTICENTER, RETROSPECTIVE- PROSPECTIVE ITALIAN STUDY.

Author

Castellino, A., primary, Castellino, C., additional, Boccomini, C., additional, Clerico, M., additional, Nicoli, P., additional, Vanazzi, A., additional, Fanelli, F., additional, Perrone, T., additional, Marchesi, F., additional, Cocito, F., additional, Merli, M., additional, Bigliardi, S., additional, Mecacci, B., additional, Bozzoli, V., additional, Margiotta-Casaluci, G., additional, Meli, E., additional, Anastasia, A., additional, Farina, L., additional, Annibali, O., additional, Gottardi, D., additional, Zanni, M., additional, Conconi, A., additional, Ciochetto, C., additional, Cenfra, N., additional, Rotondo, F., additional, Ratotti, S., additional, Cuneo, A., additional, Selleri, C., additional, Galimberti, S., additional, and Massaia, M., additional

Published
2022
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13. Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective, multicentre, cohort study

Author

Passamonti, F, Cattaneo, C, Arcaini, L, Bruna, R, Cavo, M, Merli, F, Angelucci, E, Krampera, M, Cairoli, R, Della Porta, M, Fracchiolla, N, Ladetto, M, Gambacorti Passerini, C, Salvini, M, Marchetti, M, Lemoli, R, Molteni, A, Busca, A, Cuneo, A, Romano, A, Giuliani, N, Galimberti, S, Corso, A, Morotti, A, Falini, B, Billio, A, Gherlinzoni, F, Visani, G, Tisi, M, Tafuri, A, Tosi, P, Lanza, F, Massaia, M, Turrini, M, Ferrara, F, Gurrieri, C, Vallisa, D, Martelli, M, Derenzini, E, Guarini, A, Conconi, A, Cuccaro, A, Cudillo, L, Russo, D, Ciambelli, F, Scattolin, A, Luppi, M, Selleri, C, Ortu La Barbera, E, Ferrandina, C, Di Renzo, N, Olivieri, A, Bocchia, M, Gentile, M, Marchesi, F, Musto, P, Federici, A, Candoni, A, Venditti, A, Fava, C, Pinto, A, Galieni, P, Rigacci, L, Armiento, D, Pane, F, Oberti, M, Zappasodi, P, Visco, C, Franchi, M, Grossi, P, Bertu, L, Corrao, G, Pagano, L, Corradini, P, Passamonti F., Cattaneo C., Arcaini L., Bruna R., Cavo M., Merli F., Angelucci E., Krampera M., Cairoli R., Della Porta M. G., Fracchiolla N., Ladetto M., Gambacorti Passerini C., Salvini M., Marchetti M., Lemoli R., Molteni A., Busca A., Cuneo A., Romano A., Giuliani N., Galimberti S., Corso A., Morotti A., Falini B., Billio A., Gherlinzoni F., Visani G., Tisi M. C., Tafuri A., Tosi P., Lanza F., Massaia M., Turrini M., Ferrara F., Gurrieri C., Vallisa D., Martelli M., Derenzini E., Guarini A., Conconi A., Cuccaro A., Cudillo L., Russo D., Ciambelli F., Scattolin A. M., Luppi M., Selleri C., Ortu La Barbera E., Ferrandina C., Di Renzo N., Olivieri A., Bocchia M., Gentile M., Marchesi F., Musto P., Federici A. B., Candoni A., Venditti A., Fava C., Pinto A., Galieni P., Rigacci L., Armiento D., Pane F., Oberti M., Zappasodi P., Visco C., Franchi M., Grossi P. A., Bertu L., Corrao G., Pagano L., Corradini P., Passamonti, F, Cattaneo, C, Arcaini, L, Bruna, R, Cavo, M, Merli, F, Angelucci, E, Krampera, M, Cairoli, R, Della Porta, M, Fracchiolla, N, Ladetto, M, Gambacorti Passerini, C, Salvini, M, Marchetti, M, Lemoli, R, Molteni, A, Busca, A, Cuneo, A, Romano, A, Giuliani, N, Galimberti, S, Corso, A, Morotti, A, Falini, B, Billio, A, Gherlinzoni, F, Visani, G, Tisi, M, Tafuri, A, Tosi, P, Lanza, F, Massaia, M, Turrini, M, Ferrara, F, Gurrieri, C, Vallisa, D, Martelli, M, Derenzini, E, Guarini, A, Conconi, A, Cuccaro, A, Cudillo, L, Russo, D, Ciambelli, F, Scattolin, A, Luppi, M, Selleri, C, Ortu La Barbera, E, Ferrandina, C, Di Renzo, N, Olivieri, A, Bocchia, M, Gentile, M, Marchesi, F, Musto, P, Federici, A, Candoni, A, Venditti, A, Fava, C, Pinto, A, Galieni, P, Rigacci, L, Armiento, D, Pane, F, Oberti, M, Zappasodi, P, Visco, C, Franchi, M, Grossi, P, Bertu, L, Corrao, G, Pagano, L, Corradini, P, Passamonti F., Cattaneo C., Arcaini L., Bruna R., Cavo M., Merli F., Angelucci E., Krampera M., Cairoli R., Della Porta M. G., Fracchiolla N., Ladetto M., Gambacorti Passerini C., Salvini M., Marchetti M., Lemoli R., Molteni A., Busca A., Cuneo A., Romano A., Giuliani N., Galimberti S., Corso A., Morotti A., Falini B., Billio A., Gherlinzoni F., Visani G., Tisi M. C., Tafuri A., Tosi P., Lanza F., Massaia M., Turrini M., Ferrara F., Gurrieri C., Vallisa D., Martelli M., Derenzini E., Guarini A., Conconi A., Cuccaro A., Cudillo L., Russo D., Ciambelli F., Scattolin A. M., Luppi M., Selleri C., Ortu La Barbera E., Ferrandina C., Di Renzo N., Olivieri A., Bocchia M., Gentile M., Marchesi F., Musto P., Federici A. B., Candoni A., Venditti A., Fava C., Pinto A., Galieni P., Rigacci L., Armiento D., Pane F., Oberti M., Zappasodi P., Visco C., Franchi M., Grossi P. A., Bertu L., Corrao G., Pagano L., and Corradini P.

Abstract

Background: Several small studies on patients with COVID-19 and haematological malignancies are available showing a high mortality in this population. The Italian Hematology Alliance on COVID-19 aimed to collect data from adult patients with haematological malignancies who required hospitalisation for COVID-19. Methods: This multicentre, retrospective, cohort study included adult patients (aged ≥18 years) with diagnosis of a WHO-defined haematological malignancy admitted to 66 Italian hospitals between Feb 25 and May 18, 2020, with laboratory-confirmed and symptomatic COVID-19. Data cutoff for this analysis was June 22, 2020. The primary outcome was mortality and evaluation of potential predictive parameters of mortality. We calculated standardised mortality ratios between observed death in the study cohort and expected death by applying stratum-specific mortality rates of the Italian population with COVID-19 and an Italian cohort of 31 993 patients with haematological malignancies without COVID-19 (data up to March 1, 2019). Multivariable Cox proportional hazards model was used to identify factors associated with overall survival. This study is registered with ClinicalTrials.gov, NCT04352556, and the prospective part of the study is ongoing. Findings: We enrolled 536 patients with a median follow-up of 20 days (IQR 10–34) at data cutoff, 85 (16%) of whom were managed as outpatients. 440 (98%) of 451 hospitalised patients completed their hospital course (were either discharged alive or died). 198 (37%) of 536 patients died. When compared with the general Italian population with COVID-19, the standardised mortality ratio was 2·04 (95% CI 1·77–2·34) in our whole study cohort and 3·72 (2·86–4·64) in individuals younger than 70 years. When compared with the non-COVID-19 cohort with haematological malignancies, the standardised mortality ratio was 41·3 (38·1–44·9). Older age (hazard ratio 1·03, 95% CI 1·01–1·05); progressive disease status (2·10, 1·41–3·12); diagnosis of

Published
2020

14. Secondary infections worsen the outcome of COVID-19 in patients with hematological malignancies: A report from the ITA-HEMA-COV

Author

Zappasodi, P., Cattaneo, C., Valeria Ferretti, V., Mina, R., Jose Maria Ferreri, A., Merli, F., Oberti, M., Krampera, M., Romano, A., Zerbi, C., Ferrari, J., Cavo, M., Salvini, M., Bertu, L., Stefano Fracchiolla, N., Marchesi, F., Massaia, M., Marasco, V., Cairoli, R., Maria Scattolin, A., Maria Vannucchi, A., Gambacorti-Passerini, C., Musto, P., Gherlinzoni, F., Cuneo, A., Pinto, A., Trentin, L., Bocchia, M., Galimberti, S., Coviello, E., Chiara Tisi, M., Morotti, A., Falini, B., Turrini, M., Tafuri, A., Billio, A., Gentile, M., Massimo Lemoli, R., Venditti, A., Giovanni Della Porta, M., Lanza, F., Rigacci, L., Tosi, P., Mohamed, S., Corso, A., Luppi, M., Giuliani, N., Busca, A., Pagano, Livio, Bruno, R., Antonio Grossi, P., Corradini, P., Passamonti, F., Arcaini, L., Pagano L. (ORCID:0000-0001-8287-928X), Zappasodi, P., Cattaneo, C., Valeria Ferretti, V., Mina, R., Jose Maria Ferreri, A., Merli, F., Oberti, M., Krampera, M., Romano, A., Zerbi, C., Ferrari, J., Cavo, M., Salvini, M., Bertu, L., Stefano Fracchiolla, N., Marchesi, F., Massaia, M., Marasco, V., Cairoli, R., Maria Scattolin, A., Maria Vannucchi, A., Gambacorti-Passerini, C., Musto, P., Gherlinzoni, F., Cuneo, A., Pinto, A., Trentin, L., Bocchia, M., Galimberti, S., Coviello, E., Chiara Tisi, M., Morotti, A., Falini, B., Turrini, M., Tafuri, A., Billio, A., Gentile, M., Massimo Lemoli, R., Venditti, A., Giovanni Della Porta, M., Lanza, F., Rigacci, L., Tosi, P., Mohamed, S., Corso, A., Luppi, M., Giuliani, N., Busca, A., Pagano, Livio, Bruno, R., Antonio Grossi, P., Corradini, P., Passamonti, F., Arcaini, L., and Pagano L. (ORCID:0000-0001-8287-928X)

Abstract

The impact of secondary infections (SI) on COVID-19 outcome in patients with hematological malignancies (HM) is scarcely documented. To evaluate incidence, clinical characteristics, and outcome of SI, we analyzed the microbiologically documented SI in a large multicenter cohort of adult HM patients with COVID-19. Among 1741 HM patients with COVID-19, 134 (7.7%) had 185 SI, with a 1-month cumulative incidence of 5%. Median time between COVID-19 diagnosis and SI was 16 days (IQR: 5–36). Acute myeloid leukemia (AML) and lymphoma/plasma cell neoplasms (PCN) were more frequent diagnoses in SI patients compared to patients without SI (AML: 14.9% vs. 7.1%; lymphoma/PCN 71.7% vs. 65.3%). Patients with SI were older (median age 70 vs. 66 years, p = 0.002), with more comorbidities (median Charlson Comorbidity Index 5 vs. 4, p < 0.001), higher frequency of critical COVID-19 (19.5% vs. 11.5%, p = 0.046), and more frequently not in complete remission (75% vs. 64.7% p = 0.024). Blood and bronchoalveolar lavage were the main sites of isolation for SI. Etiology of infections was bacterial in 80% (n = 148) of cases, mycotic in 9.7% (n = 18) and viral in 10.3% (n = 19); polymicrobial infections were observed in 24 patients (18%). Escherichia coli represented most of Gram-negative isolates (18.9%), while coagulase-negative Staphylococci were the most frequent among Gram-positive (14.2%). The 30-day mortality of patients with SI was higher when compared to patients without SI (69% vs. 15%, p < 0.001). The occurrence of SI worsened COVID-19 outcome in HM patients. Timely diagnosis and adequate management should be considered to improve their prognosis.

Published
2022

17. COVID-19 elicits an impaired antibody response against SARS-CoV-2 in patients with haematological malignancies

Author

Passamonti, F., Romano, A., Salvini, M., Merli, F., Porta, M. G. D., Bruna, R., Coviello, E., Romano, I., Cairoli, R., Lemoli, R., Farina, F., Venditti, A., Busca, A., Ladetto, M., Massaia, M., Pinto, A., Arcaini, L., Tafuri, A., Marchesi, F., Fracchiolla, N., Bocchia, M., Armiento, D., Candoni, A., Krampera, M., Luppi, M., Cardinali, V., Galimberti, S., Cattaneo, C., La Barbera, E. O., Mina, R., Lanza, F., Visani, G., Musto, P., Petrucci, L., Zaja, F., Grossi, P. A., Bertu, L., Pagano, Livio, Corradini, P., Derenzini, E., Marchetti, M., Scattolin, A. M., Corso, A., Tosi, P., Gherlinzoni, F., Passerini, C. G., Cavo, M., Fava, C., Turrini, M., Visco, C., Zappasodi, P., Merli, M., Mora, B., Vannucchi, A. M., Pagano L. (ORCID:0000-0001-8287-928X), Passamonti, F., Romano, A., Salvini, M., Merli, F., Porta, M. G. D., Bruna, R., Coviello, E., Romano, I., Cairoli, R., Lemoli, R., Farina, F., Venditti, A., Busca, A., Ladetto, M., Massaia, M., Pinto, A., Arcaini, L., Tafuri, A., Marchesi, F., Fracchiolla, N., Bocchia, M., Armiento, D., Candoni, A., Krampera, M., Luppi, M., Cardinali, V., Galimberti, S., Cattaneo, C., La Barbera, E. O., Mina, R., Lanza, F., Visani, G., Musto, P., Petrucci, L., Zaja, F., Grossi, P. A., Bertu, L., Pagano, Livio, Corradini, P., Derenzini, E., Marchetti, M., Scattolin, A. M., Corso, A., Tosi, P., Gherlinzoni, F., Passerini, C. G., Cavo, M., Fava, C., Turrini, M., Visco, C., Zappasodi, P., Merli, M., Mora, B., Vannucchi, A. M., and Pagano L. (ORCID:0000-0001-8287-928X)

Abstract

COVID-19 is associated with high mortality in patients with haematological malignancies (HM) and rate of seroconversion is unknown. The ITA-HEMA-COV project (NCT04352556) investigated patterns of seroconversion for SARS-CoV-2 IgG in patients with HMs. A total of 237 patients, SARS-CoV-2 PCR-positive with at least one SARS-CoV-2 IgG test performed during their care, entered the analysis. Among these, 62 (26·2%) had myeloid, 121 (51·1%) lymphoid and 54 (22·8%) plasma cell neoplasms. Overall, 69% of patients (164 of 237) had detectable IgG SARS-CoV-2 serum antibodies. Serologically negative patients (31%, 73 of 237) were evenly distributed across patients with myeloid, lymphoid and plasma cell neoplasms. In the multivariable logistic regression, chemoimmunotherapy [odds ratio (OR), 3·42; 95% confidence interval (CI), 1·04–11·21; P = 0·04] was associated with a lower rate of seroconversion. This effect did not decline after 180 days from treatment withdrawal (OR, 0·35; 95% CI: 0·11–1·13; P = 0·08). This study demonstrates a low rate of seroconversion in HM patients and indicates that treatment-mediated immune dysfunction is the main driver. As a consequence, we expect a low rate of seroconversion after vaccination and thus we suggest testing the efficacy of seroconversion in HM patients.

Published
2021

20. Practical management of ibrutinib in the real life: Focus on atrial fibrillation and bleeding

Author

Boriani, G, Corradini, P, Cuneo, A, Falanga, A, Foà, R, Gaidano, G, Ghia, P, Martelli, M, Marasca, R, Massaia, M, Mauro, F, Minotti, G, Molica, S, Montillo, M, Pinto, A, Tedeschi, A, Vitolo, U, Zinzani, P, Boriani G, Corradini P, Cuneo A, Falanga A, Foà R, Gaidano G, Ghia PP, Martelli M, Marasca R, Massaia M, Mauro FR, Minotti G, Molica S, Montillo M, Pinto A, Tedeschi A, Vitolo U, Zinzani PL, Boriani, G, Corradini, P, Cuneo, A, Falanga, A, Foà, R, Gaidano, G, Ghia, P, Martelli, M, Marasca, R, Massaia, M, Mauro, F, Minotti, G, Molica, S, Montillo, M, Pinto, A, Tedeschi, A, Vitolo, U, Zinzani, P, Boriani G, Corradini P, Cuneo A, Falanga A, Foà R, Gaidano G, Ghia PP, Martelli M, Marasca R, Massaia M, Mauro FR, Minotti G, Molica S, Montillo M, Pinto A, Tedeschi A, Vitolo U, and Zinzani PL

Abstract

The Bruton tyrosine kinase inhibitor ibrutinib (IB) has attained an important role in the treatment of patients with chronic lymphocytic leukaemia, mantle cell lymphoma, and Waldenström macroglobulinemia, significantly improving clinical outcomes. However, IB therapy has been associated with an increased risk of atrial fibrillation (AF) and bleeding. We report on the expert opinion that a group of Italian haematologists, cardiologists, and pharmacologists jointly released to improve the practical management of patients at risk for AF and bleeding during treatment with IB. A proper pretreatment assessment to identify patients who are at a higher risk, careful choice of concomitant drugs, regular monitoring, and multispecialist approach were characterized as the main principles of clinical management of these patients. For patients developing AF, anticoagulant and antiarrhythmic therapy must be guided by considerations about efficacy, safety, and risk of pharmacokinetic interactions with IB. For patients experiencing bleeding or requiring procedures that increase the risk of bleeding, considerations about platelet turnover, IB-related platelet dysfunctions, and bleeding worsening by concomitant anticoagulants or antiplatelet agents provide clues to manage bleeding. Overall, AF and bleeding are manageable clinical events in patients receiving IB, not requiring drug interruption in most cases. Preexisting AF should not represent an absolute contraindication to IB therapy. For each patient candidate for IB, strategies of risk assessment and mitigation may allow to exploit the life-saving effects of in chronic lymphocytic leukaemia and mantle cell lymphoma

Published
2018

21. HIF-1α is over-expressed in leukemic cells from TP53-disrupted patients and is a promising therapeutic target in chronic lymphocytic leukemia

Author

Griggio, V., Vitale, C., Todaro, M., Riganti, C., Kopecka, J., Salvetti, C., Bomben, R., M. D., Bo, Magliulo, D., Rossi, D., Pozzato, G., Bonello, L., Marchetti, M., Omede, P., Kodipad, A. A., Laurenti, L., Poeta, G. D., Mauro, F. R., Bernardi, R., Zenz, T., Gattei, V., Gaidano, G., Foa, R., Massaia, M., Boccadoro, M., and Coscia, M.

Subjects
Animals, Humans, Hypoxia-Inducible Factor 1, alpha Subunit, Mice, Phosphatidylinositol 3-Kinases, Tumor Microenvironment, Tumor Suppressor Protein p53, Von Hippel-Lindau Tumor Suppressor Protein, Leukemia, Lymphocytic, Chronic, B-Cell
Published
2020

26. Tandem auto-miniALLO approach for newly diagnosed multiple myeloma: an update of the Italian experience

Author

Bruno, B., Patriarca, F., Rotta, M., Maloney, D., Mordini, N., Casini, M., Rambaldi, A., Carnevale-Schianca, F., Allione, B., Soligo, D., Bavaro, P., Giaccone, L., Sorsasio, R., Montefusco, V., Busca, A., Fanin, R., Gallamini, A., Coser, P., Corradini, P., Levis, A., Aglietta, M., Pogliani, E., Falda, M., Massaia, M., Palumbo, A., Sandmaier, B., Storb, R., and Boccadoro, M.

Published
2005

27. Low-dose TBI-based non-myeloablative allografting in newly diagnosed multiple myeloma

Author

Bruno, B., Patriarca, F., Rotta, M., Maloney, D., Mordini, N., Casini, M., Rambaldi, A., Carnevale-Schianca, F., Allione, B., Soligo, D., Bavaro, P., De Fabritiis, P., Giaccone, L., Aitoro, G., Corradini, P., Busca, A., Fanin, R., Gallamini, A., Coser, P., Levis, A., Aglietta, M., Pogliani, E., Falda, M., Massaia, M., Palumbo, A., Sandmaier, B., Storb, R., and Boccadoro, M.

Published
2004

30. A phase II multi-center trial of pentostatin plus cyclophosphamide with ofatumumab in older previously untreated chronic lymphocytic leukemia patients

Author

Tedeschi, A, Rossi, D, Motta, M, Quaresmini, G, Rossi, M, Coscia, M, Anastasia, A, Rossini, F, Cortelezzi, A, Nador, G, Scarfo, L, Cairoli, R, Frustaci, A, Dalceggio, D, Picardi, P, de Paoli, L, Orlandi, E, Rambaldi, A, Massaia, M, Gaidano, G, Montillo, M, Tedeschi A., Rossi D., Motta M., Quaresmini G., Rossi M., Coscia M., Anastasia A., Rossini F., Cortelezzi A., Nador G., Scarfo L., Cairoli R., Frustaci A. M., Dalceggio D., Picardi P., de Paoli L., Orlandi E., Rambaldi A., Massaia M., Gaidano G., Montillo M., Tedeschi, A, Rossi, D, Motta, M, Quaresmini, G, Rossi, M, Coscia, M, Anastasia, A, Rossini, F, Cortelezzi, A, Nador, G, Scarfo, L, Cairoli, R, Frustaci, A, Dalceggio, D, Picardi, P, de Paoli, L, Orlandi, E, Rambaldi, A, Massaia, M, Gaidano, G, Montillo, M, Tedeschi A., Rossi D., Motta M., Quaresmini G., Rossi M., Coscia M., Anastasia A., Rossini F., Cortelezzi A., Nador G., Scarfo L., Cairoli R., Frustaci A. M., Dalceggio D., Picardi P., de Paoli L., Orlandi E., Rambaldi A., Massaia M., Gaidano G., and Montillo M.

Published
2015

33. Microvesicles released from multiple myeloma cells are equipped with ectoenzymes belonging to canonical and non-canonical adenosinergic pathways and produce adenosine from ATP and NAD+

Author

Morandi, F., primary, Marimpietri, D., additional, Horenstein, A. L., additional, Bolzoni, M., additional, Toscani, D., additional, Costa, F., additional, Castella, B., additional, Faini, A. C., additional, Massaia, M., additional, Pistoia, V., additional, Giuliani, N., additional, and Malavasi, F., additional

Published
2018
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34. A PHASE II MULTI-CENTER TRIAL OF PENTOSTATIN PLUS CYCLOPHOSPHAMIDE WITH OFATUMUMAB (PCO) IN OLDER PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) PATIENTS

Author

Montillo, M, Rossi, D, Motta, M, Quaresmini, G, Rossi, M, Coscia, M, Anastasia, A, Rossini, F, Cortellezzi, A, Nador, N, Scarfo, L, Cairoli, R, Frustaci, A, Dal Ceggio, D, Picardi, P, De Paoli, L, Orlandi, E, Rambaldi, A, Morra, M, Massaia, M, Tedeschi, A, Montillo M, Rossi D, Motta M, Quaresmini G, Rossi M, Coscia M, Anastasia A, Rossini F, Cortellezzi A, Nador N, Scarfo L, Cairoli R, Frustaci AM, Dal Ceggio D, Picardi P, De Paoli L, Orlandi E, Rambaldi A, Morra M, Massaia M, Tedeschi A, Montillo, M, Rossi, D, Motta, M, Quaresmini, G, Rossi, M, Coscia, M, Anastasia, A, Rossini, F, Cortellezzi, A, Nador, N, Scarfo, L, Cairoli, R, Frustaci, A, Dal Ceggio, D, Picardi, P, De Paoli, L, Orlandi, E, Rambaldi, A, Morra, M, Massaia, M, Tedeschi, A, Montillo M, Rossi D, Motta M, Quaresmini G, Rossi M, Coscia M, Anastasia A, Rossini F, Cortellezzi A, Nador N, Scarfo L, Cairoli R, Frustaci AM, Dal Ceggio D, Picardi P, De Paoli L, Orlandi E, Rambaldi A, Morra M, Massaia M, and Tedeschi A

Published
2014

36. A MRD-GUIDED APPROACH FOR THE COMBINATION OF IBRUTINIB TO VENETOCLAX IN RELAPSED/REFRACTORY PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (IMPROVE STUDY)

Author

Ghia, P., primary, Scarfò, L., additional, Coscia, M., additional, Sancetta, R., additional, Ferrario, A., additional, Tedeschi, A., additional, Farina, L., additional, Laurenti, L., additional, Orlandi, E., additional, Reda, G., additional, Motta, M., additional, Carlo Stella, C., additional, Massaia, M., additional, Quaresmini, G., additional, Rossini, F., additional, Ladetto, M., additional, Gaidano, G., additional, Rossi, V., additional, and Montillo, M., additional

Published
2017
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38. IMMUNE RECONSTITUTION AND THYMIC FUNCTION AFTER REDUCED INTENSITY ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION

Author

Bruno B, Omedè P, Cena S, Noviello M, Gilestro M, Cimolin L, Sfiligoi SMC, Galletto E, Veneziano L, Giaccone L, Sorasio R, Festuccia M, Ferrando F, Brunello L, Massaia M, Aiuti A, Passera R, Fagioli F, Boccadoro M., BONINI , MARIA CHIARA, Bruno, B, Omedè, P, Cena, S, Noviello, M, Gilestro, M, Cimolin, L, Sfiligoi, Smc, Galletto, E, Veneziano, L, Giaccone, L, Sorasio, R, Festuccia, M, Ferrando, F, Brunello, L, Massaia, M, Aiuti, A, Bonini, MARIA CHIARA, Passera, R, Fagioli, F, and Boccadoro, M.

Published
2010

39. A Molecular Model to Predict Durable Remission after First Line Fludarabine-Cyclophosphamide-Rituximab Treatment in Chronic Lymphocytic Leukemia

Author

Rossi, D, di Bergamo, Lt, Chiarenza, A, Bulian, P, Visco, C, Mauro, Fr, Morabito, F, Cortelezzi, A, Zaja, F, Forconi, F, Laurenti, L, Del Giudice, I, De Paoli, L, Vincelli, I, Rigolin, Gian Matteo, Marasca, R, Perbellini, O, Moreno, C, Del Poeta, G, Massaia, M, Zinzani, Pl, Montillo, M, Cuneo, Antonio, Foa, R, Gattei, V, and Gaidano, G.

Subjects
CLL, FCR, molecular analysis, FCR, molecular analysis, CLL, NO
Published
2014

40. Fludarabine plus alemtuzumab (FA) front-line treatment in young patients with chronic lymphocytic leukemia (CLL) and an adverse biologic profile

Author

Mauro Francesca, R, Molica, Stefano, Laurenti, Luca, Cortelezzi, Agostino, Carella Angelo, M., Zaja, Francesco, Chiarenza, Annalisa, Angrilli, Francesco, Nobile, Francesco, Marasca, Roberto, Musolino, Caterina, Brugiatelli, Maura, Piciocchi, Alfonso, Vignetti, Marco, Fazi, Paola, Gentile, Giuseppe, De Propris Maria, S., Starza Irene Della, Marinelli, Marilisa, Chiaretti, Sabina, Del Giudice Ilaria, Nanni, Mauro, Albano, Francesco, Cuneo, Antonio, Guarini, Anna, Foà, Robin, per il gruppo GIMEMA Working Party Chronic Lymph, Massaia, M., Mauro, Fr, Molica, S, Laurenti, L, Cortelezzi, A, Carella, Am, Zaja, Francesco, Chiarenza, A, Angrilli, F, Nobile, F, Marasca, R, Musolino, C, Brugiatelli, M, Piciocchi, A, Vignetti, M, Fazi, P, Gentile, G, De Propris, M, Della Starza, I, Marinelli, M, Chiaretti, S, Del Giudice, I, Nanni, M, Albano, F, Cuneo, A, Guarini, A, and Foà, R.

Subjects
Oncology, Male, Cancer Research, medicine.medical_treatment, Chronic lymphocytic leukemia, THERAPY, Fludarabine, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Medicine, Chronic, Alemtuzumab, Humanized, Vidarabine, Neoadjuvant therapy, Hematology, Leukemia, STEM CELL TRANSPLANTATION, Medicine (all), Middle Aged, Lymphocytic, Neoadjuvant Therapy, Treatment Outcome, Female, PHASE-II TRIAL, medicine.drug, EXPRESSION, Adult, medicine.medical_specialty, Young, Biology, CLL, Antibodies, Monoclonal, Humanized, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Survival Analysis, Antibodies, Chronic lymphocytic leukemia, CLL, Young, Biology, Fludarabine, Alemtuzumab, STEM CELL TRANSPLANTATION, PHASE-II TRIAL, TERM FOLLOW UP, SUBCUTANEOUS ALEMTUZUMAB, DISEASE PROGRESSION, POOR PROGNOSIS, FREE SURVIVAL, EXPRESSION, RITUXIMAB, THERAPY, Internal medicine, SUBCUTANEOUS ALEMTUZUMAB, RITUXIMAB, Survival analysis, business.industry, DISEASE PROGRESSION, B-Cell, medicine.disease, Transplantation, Settore MED/15 - MALATTIE DEL SANGUE, POOR PROGNOSIS, Immunology, TERM FOLLOW UP, FREE SURVIVAL, business
Abstract

In 45, ≤ 60 years old patients with CLL and an adverse biologic profile, a front-line treatment with Fludarabine and Campath (Alemtuzumab(®)) was given. The overall response rate was 75.5%, the complete response rate (CR) 24.4% with the lowest CR rates, 16.7% and 8.3%, in 11q and 17p deleted cases. The 3-year progression-free survival (PFS) and overall survival were 42.5% and 79.9%, respectively. PFS was significantly influenced by CLL duration, beta2-microglobulin, and improved by post-remissional stem cell transplantation. Front-line fludarabine and alemtuzumab showed a manageable safety profile and evidence of a benefit in a small series of CLL patients with adverse biologic features.

Published
2014

41. Chlorambucil plus rituximab with or without maintenance rituximab as first-line treatment for elderly chronic lymphocytic leukemia patients

Author

Foà, R, Del Giudice, I, Cuneo, Antonio, Del Poeta, G, Ciolli, S, Di Raimondo, F, Lauria, F, Cencini, E, Rigolin, Gian Matteo, Cortelezzi, A, Nobile, F, Callea, V, Brugiatelli, M, Massaia, M, Molica, S, Trentin, L, Rizzi, R, Specchia, G, Di Serio, F, Orsucci, L, Ambrosetti, A, Montillo, M, Luigi Zinzani, P, Ferrara, F, Morabito, F, Angela Mura, M, Soriani, S, Peragine, N, Tavolaro, S, Bonina, S, Marinelli, M, Stefania De Propris, M, Della Starza, I, Piciocchi, A, Alietti, A, Runggaldier, Ej, Gamba, E, Romana Mauro, F, Chiaretti, S, Guarini, A., R. Foà, I. D. Giudice, A. Cuneo, G. D. Poeta, S. Ciolli, F. D. Raimondo, F. Lauria, E. Cencini, G. M. Rigolin, A. Cortelezzi, F. Nobile, V. Callea, M. Brugiatelli, M. Massaia, S. Molica, L. Trentin, R. Rizzi, G. Specchia, F. D. Serio, L. Orsucci, A. Ambrosetti, M. Montillo, P. L. Zinzani, F. Ferrara, F. Morabito, M. A. Mura, S. Soriani, N. Peragine, S. Tavolaro, S. Bonina, M. Marinelli, M. S. De, I. D. Starza, A. Piciocchi, A. Alietti, E. J. Runggaldier, E. Gamba, F. R. Mauro, S. Chiaretti, and A. Guarini

Subjects
Male, Murine-Derived, drug therapy/pathology, Male, Survival Analysis, Treatment Outcome, Antibodies, Disease-Free Survival, Drug Administration Schedule, Antibodies, Monoclonal, Murine-Derived, Antineoplastic Combined Chemotherapy Protocols, Monoclonal, 80 and over, 80 and over, Antibodie, Humans, therapeutic use, Chlorambucil, Chronic, Aged, Aged, 80 and over, Aged, Aged, Leukemia, Chlorambucil, Female, Induction Chemotherapy, Leukemia, Lymphocytic, Chronic, B-Cell, Rituximab, Survival Analysis, Treatment Outcome, Hematology, B-Cell, Lymphocytic, CLL, chlorambucil, administration /&/ dosage, Antineoplastic Combined Chemotherapy Protocol, administration /&/ dosage, Disease-Free Survival, Drug Administration Schedule, Female, Humans, Induction Chemotherapy, Leukemia, Settore MED/15 - Malattie del Sangue
Abstract

In a phase II trial, we evaluated chlorambucil and rituximab (CLB-R) as first-line induction treatment with or without R as maintenance for elderly chronic lymphocytic leukemia (CLL) patients. Treatment consisted of eight 28-day cycles of CLB (8 mg/m(2) /day, days 1-7) and R (day 1 of cycle 3, 375 mg/m(2) ; cycles 4-8, 500 mg/m(2) ). Responders were randomized to 12 8-week doses of R (375 mg/m(2) ) or observation. As per intention-to-treat analysis, 82.4\% (95\% CI, 74.25-90.46\%) of 85 patients achieved an overall response (OR), 16.5\% a complete response (CR), 2.4\% a CR with incomplete bone marrow recovery. The OR was similar across Binet stages (A 86.4\%, B 81.6\%, and C 78.6\%) and age categories (60-64 years, 92.3\%; 65-69, 85.2\%; 70-74, 75.0\%; ≥75, 81.0\%). CLB-R was well tolerated. After a median follow-up of 34.2 months, the median progression-free survival (PFS) was 34.7 months (95\% CI, 33.1-39.5). TP53 abnormalities, complex karyotype, and low CD20 gene expression predicted lack of response; SF3B1 mutation and BIRC3 disruption low CR rates. IGHV mutations significantly predicted PFS. R maintenance tended towards a better PFS than observation and was safe and most beneficial for patients in partial response and for unmutated IGHV cases. CLB-R represents a promising option for elderly CLL patients.

Published
2014

42. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia.

Author

Deshmukh C.D., Offner F., Van Den Neste E.W., Wu K.L., Van Hoof A., Maiolino A., Pinczowski H., Zanichelli M.A., Pereira J., Larratt L., Spaner D., Howson-Jan K., Chen C.I., Cantin G., Fernandez L.A., Fraser G., Mayer J., Trneny M., Jebavy L., Bordessoule D., Lamy T., Milpied N., Truchan-Graczyk M., Eghbali H., Karsenti J.-M., Celigny P.S., Mans L., Cazin B., Gyan E., Lepretre S., Bergmann L., Tsionos K., Lokeshwar N.M., Agarwal M.B., Ross C.R., Narayanan G., Raina V., Bondarde S.A., Shah B.A., Bairey O., Tikva P., Shvidel L., Ambrosetti A., Rossi P.G.B., Angelucci E., Carella A.M., Massaia M., Zinzani P.L., Caligaris-Cappio F., Foa R., Gaidano G., della Carita A.O.M., Leone G., Santoro A., Griskevicius L., Jurgutis R., Baker B.W., Hawkins T., Corbett G.M., Ganly P., D'Souza A.B., Deptala A., Holowiecki J., Kloczko J., Skotnicki A., Zdziarska B., Kyrcz-Krzemien S., Dmoszynska A., Moreira I., Pereira A.P., Colita A., Moicean A.D., Vasilica M., Danaila C., Gheorghita E., Pavlov V.V., Rossiev V.A., Konstantinova T., Samoilova O.S., Novgorod N., Shelekhova T., Zaritsky A.Y., Abdulkadyrov K.M., Zyuzgin I.S., Pristupa A.S., Loscertales J., Vidal J.B., de Mallorca P., Gonzalez M., Ortuno F., Giraldo P., Nathwani A., Agrawal S.G., Rule S., Dearden C.E., Bloor A.J., Haynes A., Singer C., Boclek R.G., Bosserman L.D., Chan D., Davidson S.J., Dichmann R.A., Farber C., Hart L., Hermann R., Hu E., Janakiraman N., Jonas W., Liem K.D., Mcintyre R.E., O'Brien S., Patel G., Rado T., Schilder R., Smith S.E., Stock W., Turturro F., Venugopal P., Anderson T.C., Berry W., Boyd T.E., Byrd J., Cooper M., Flinn I., Gersh R., Gordon D., Guzley G.J., Wilks S.T., Klein A., Krauss J.C., Lister J., Mandell L., Molina A., Cooper B., Pendergrass K.B., Reeder C., Savin M.A., Spitzer G., Tuscano J.M., vanDeventer H., Eradat H.A., Masood A., Mena R., Awan F.T., Hillmen P., Hellmann A., Robak T., Hughes S.G., Trone D., Shannon M., Flinn I.W., Byrd J.C., Riveros D., Pavlovsky S., Iastrebner C.M., Carney D.A., Deveridge S., Durrant S., Hahn U.H., Hertzberg M., Leahy M.F., Ma D., Marlton P., Mulligan S., Opat S.S., Tiley C., Wickham N.W., Cannell P., Gatalano J., Catalano J., Cull G., To L.B., Hopfinger G., Jager U., Linkesch W., Petzer A., Schwarzmeier J., Steurer M., Greil R., Bememan Z., Bosly A., Bron D., Janssens A., Deshmukh C.D., Offner F., Van Den Neste E.W., Wu K.L., Van Hoof A., Maiolino A., Pinczowski H., Zanichelli M.A., Pereira J., Larratt L., Spaner D., Howson-Jan K., Chen C.I., Cantin G., Fernandez L.A., Fraser G., Mayer J., Trneny M., Jebavy L., Bordessoule D., Lamy T., Milpied N., Truchan-Graczyk M., Eghbali H., Karsenti J.-M., Celigny P.S., Mans L., Cazin B., Gyan E., Lepretre S., Bergmann L., Tsionos K., Lokeshwar N.M., Agarwal M.B., Ross C.R., Narayanan G., Raina V., Bondarde S.A., Shah B.A., Bairey O., Tikva P., Shvidel L., Ambrosetti A., Rossi P.G.B., Angelucci E., Carella A.M., Massaia M., Zinzani P.L., Caligaris-Cappio F., Foa R., Gaidano G., della Carita A.O.M., Leone G., Santoro A., Griskevicius L., Jurgutis R., Baker B.W., Hawkins T., Corbett G.M., Ganly P., D'Souza A.B., Deptala A., Holowiecki J., Kloczko J., Skotnicki A., Zdziarska B., Kyrcz-Krzemien S., Dmoszynska A., Moreira I., Pereira A.P., Colita A., Moicean A.D., Vasilica M., Danaila C., Gheorghita E., Pavlov V.V., Rossiev V.A., Konstantinova T., Samoilova O.S., Novgorod N., Shelekhova T., Zaritsky A.Y., Abdulkadyrov K.M., Zyuzgin I.S., Pristupa A.S., Loscertales J., Vidal J.B., de Mallorca P., Gonzalez M., Ortuno F., Giraldo P., Nathwani A., Agrawal S.G., Rule S., Dearden C.E., Bloor A.J., Haynes A., Singer C., Boclek R.G., Bosserman L.D., Chan D., Davidson S.J., Dichmann R.A., Farber C., Hart L., Hermann R., Hu E., Janakiraman N., Jonas W., Liem K.D., Mcintyre R.E., O'Brien S., Patel G., Rado T., Schilder R., Smith S.E., Stock W., Turturro F., Venugopal P., Anderson T.C., Berry W., Boyd T.E., Byrd J., Cooper M., Flinn I., Gersh R., Gordon D., Guzley G.J., Wilks S.T., Klein A., Krauss J.C., Lister J., Mandell L., Molina A., Cooper B., Pendergrass K.B., Reeder C., Savin M.A., Spitzer G., Tuscano J.M., vanDeventer H., Eradat H.A., Masood A., Mena R., Awan F.T., Hillmen P., Hellmann A., Robak T., Hughes S.G., Trone D., Shannon M., Flinn I.W., Byrd J.C., Riveros D., Pavlovsky S., Iastrebner C.M., Carney D.A., Deveridge S., Durrant S., Hahn U.H., Hertzberg M., Leahy M.F., Ma D., Marlton P., Mulligan S., Opat S.S., Tiley C., Wickham N.W., Cannell P., Gatalano J., Catalano J., Cull G., To L.B., Hopfinger G., Jager U., Linkesch W., Petzer A., Schwarzmeier J., Steurer M., Greil R., Bememan Z., Bosly A., Bron D., and Janssens A.

Abstract

Summary: Lumiliximab is a chimeric monoclonal antibody that targets CD23 on the surface of chronic lymphocytic leukaemia (CLL) B-cells. Early phase clinical studies with lumiliximab alone and in combination with fludarabine, cyclophosphamide and rituximab (FCR) established its potential efficacy and tolerability. The 152CL201 trial [Lumiliximab with fludarabine, cyclophosphamide and rituximab (FCR) versus FCR alone in subjects with relapsed CLL; LUCID] was a phase 2/3, randomized (1:1), open-label, multicentre study of lumiliximab in combination with FCR versus FCR alone in patients with relapsed CLL. Six hundred and twenty-seven patients were randomized to either arm. Overall the combination of lumiliximab with FCR was not significantly better than FCR alone (overall response rate 71% vs. 72%, complete response rate 16% vs. 15%, median progression-free survival 24.6 vs. 23.9 months respectively, for FCR with and without lumiliximab). There was a slightly increased incidence of adverse events with lumiliximab but these increases did not appear to lead to differences in eventual outcomes. An interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. The study was therefore stopped early for lack of efficacy. Despite the eventual outcome, the LUCID trial is one of the largest studies that provides valuable insight into the efficacy and tolerability of FCR as a therapeutic option for patients with relapsed CLL.Copyright © 2014 John Wiley & Sons Ltd.

Published
2015

43. Molecular prediction of durable remission after first-line fludarabine-cyclophosphamide-rituximab in chronic lymphocytic leukemia.

Author

Rossi, D, Terzi-di-Bergamo, L, De Paoli, Luigi, Cerri, Marco Vittorio, Ghilardi, Giampaolo, Chiarenza, A, Bulian, P, Visco, C, Mauro, Fr, Morabito, F, Cortelezzi, A, Zaja, F, Forconi, F, Laurenti, Luca, Del Giudice, I, Gentile, M, Vincelli, I, Motta, M, Coscia, M, Rigolin, Gm, Tedeschi, Alessandra, Neri, A, Marasca, R, Perbellini, O, Moreno, C, Del Poeta, G, Massaia, M, Zinzani, Pl, Montillo, M, Cuneo, A, Gattei, V, Foà, R, Gaidano, G, Laurenti L (ORCID:0000-0002-8327-1396), Rossi, D, Terzi-di-Bergamo, L, De Paoli, Luigi, Cerri, Marco Vittorio, Ghilardi, Giampaolo, Chiarenza, A, Bulian, P, Visco, C, Mauro, Fr, Morabito, F, Cortelezzi, A, Zaja, F, Forconi, F, Laurenti, Luca, Del Giudice, I, Gentile, M, Vincelli, I, Motta, M, Coscia, M, Rigolin, Gm, Tedeschi, Alessandra, Neri, A, Marasca, R, Perbellini, O, Moreno, C, Del Poeta, G, Massaia, M, Zinzani, Pl, Montillo, M, Cuneo, A, Gattei, V, Foà, R, Gaidano, G, and Laurenti L (ORCID:0000-0002-8327-1396)

Abstract

X

Published
2015

44. Management of multiple myeloma and related-disorders: guidelines from the Italian Society of Hematology (SIE), Italian Society of Experimental Hematology (SIES) and Italian Group for Bone Marrow Transplantation (GITMO)

Author

BAROSI G, BOCCADORO M, CORRADINI P, MARCHETTI M, MASSAIA M, MERLINI G, ITALIAN SOCIETY OF HEMATOLOGY, ITALIAN SOCIETY OF EXPERIMENTAL HEMATOLOGY, ITALIAN GROUP FOR BONE MARROW TRANSPLANTATION, CAVO, MICHELE, TOSI, PATRIZIA, TURA, SANTE, BAROSI G, BOCCADORO M, CAVO M., CORRADINI P, MARCHETTI M, MASSAIA M, MERLINI G, TOSI P, TURA S, ITALIAN SOCIETY OF HEMATOLOGY, ITALIAN SOCIETY OF EXPERIMENTAL HEMATOLOGY, and ITALIAN GROUP FOR BONE MARROW TRANSPLANTATION.

Published
2004

49. A PHASE II STUDY OF CHLORAMBUCIL+RITUXIMAB (CLB-R) FOLLOWED BY R MAINTENANCE VS OBSERVATION IN ELDERLY PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA (CLL): INDUCTION PHASE RESULTS

Author

Foa, R., Alietti, A., Guarini, A., Ciolli, S., Di Raimondo, F., Del Poeta, G., Lauria, F., Forconi, F., Antonio Cuneo, Cortellezzi, A., Nobile, F., Callea, V., Brugiatelli, M., Massaia, M., Molica, S., Trentin, L., Rizzi, R., Specchia, G., Orsucci, L., Ambrosetti, A., Montillo, M., Zinzani, L., Ferrara, F., Morabito, F., Marco Mura, Soriani, S., Santangelo, S., Marinelli, M., Propris, M., and Runggaldier, J.

Published
2011

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