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1. Clonal hematopoiesis in patients with autoimmune thrombocytopenia: an international multicenter study

Author

Fattizzo, Bruno, Marchetti, Alfredo, Bosi, Alessandro, Gurnari, Carmelo, Giannotta, Juri Alessandro, Pedone, Giacinto Luca, Rossi, Elena, Carrai, Valentina, Guido, Andrea, Brioschi, Filippo, Carpenedo, Monica, Crugnola, Monica, Caramazza, Domenica, Leuzzi, Livia, Marchetti, Monia, Merati, Gabriele, Malato, Simona, Vianello, Fabrizio, Patriarca, Andrea, Awada, Hussein, Bortolotti, Marta, Canzi, Marta, Bolli, Niccolò, Capecchi, Marco, Chen, Frederick, Artoni, Andrea, Maciejewski, Jaroslaw P., and Barcellini, Wilma

Published
2025
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2. Second primary malignancies in ruxolitinib-treated myelofibrosis: real-world evidence from 219 consecutive patients

Author

Maffioli, Margherita, Giorgino, Toni, Mora, Barbara, Iurlo, Alessandra, Elli, Elena, Finazzi, Maria Chiara, Caramella, Marianna, Rumi, Elisa, Carraro, Maria Cristina, Polverelli, Nicola, D'Adda, Mariella, Malato, Simona, Rossi, Marianna, Molteni, Alfredo, Vismara, Alessandro, Sissa, Cinzia, Spina, Francesco, Anghilieri, Michela, Cattaneo, Daniele, Renso, Rossella, Bellini, Marta, Pioltelli, Maria Luisa, Cavalloni, Chiara, Barraco, Daniela, Accetta, Raffaella, Bertù, Lorenza, Della Porta, Matteo Giovanni, and Passamonti, Francesco

Published
2019
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3. Minimal residual disease detection by next-generation sequencing in multiple myeloma: Promise and challenges for response-adapted therapy

Author

Ferla, Valeria, primary, Antonini, Elena, additional, Perini, Tommaso, additional, Farina, Francesca, additional, Masottini, Serena, additional, Malato, Simona, additional, Marktel, Sarah, additional, Lupo Stanghellini, Maria Teresa, additional, Tresoldi, Cristina, additional, Ciceri, Fabio, additional, and Marcatti, Magda, additional

Published
2022
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6. Minimal residual disease detection by next-generation sequencing in multiple myeloma: Promise and challenges for responseadapted therapy.

Author

Ferla, Valeria, Antonini, Elena, Perini, Tommaso, Farina, Francesca, Masottini, Serena, Malato, Simona, Marktel, Sarah, Lupo Stanghellini, Maria Teresa, Tresoldi, Cristina, Ciceri, Fabio, and Marcatti, Magda

Subjects
MULTIPLE myeloma, NUCLEOTIDE sequencing, CHRONIC myeloid leukemia, INCURABLE diseases, DRUG bioavailability, TESTICULAR cancer
Abstract

Assessment of minimal residual disease (MRD) is becoming a standard diagnostic tool for curable hematological malignancies such as chronic and acute myeloid leukemia. Multiple myeloma (MM) remains an incurable disease, as a major portion of patients even in complete response eventually relapse, suggesting that residual disease remains. Over the past decade, the treatment landscape of MM has radically changed with the introduction of new effective drugs and the availability of immunotherapy, including targeted antibodies and adoptive cell therapy. Therefore, conventional serological and morphological techniques have become suboptimal for the evaluation of depth of response. Recently, the International Myeloma Working Group (IMWG) introduced the definition of MRD negativity as the absence of clonal Plasma cells (PC) with a minimum sensitivity of <10-5 either by next-generation sequencing (NGS) using the LymphoSIGHT platform (Sequenta/Adaptative) or by next-generation flow cytometry (NGF) using EuroFlow approaches as the reference methods. While the definition of the LymphoSIGHT platform (Sequenta/Adaptive) as the standard method derives from its large use and validation in clinical studies on the prognostic value of NGS-based MRD, other commercially available options exist. Recently, the LymphoTrack assay has been evaluated in MM, demonstrating a sensitivity level of 10-5, hence qualifying as an alternative effective tool for MRD monitoring in MM. Here, we will review state-of-the-art methods for MRD assessment by NGS. We will summarize how MRD testing supports clinical trials as a useful tool in dynamic risk-adapted therapy. Finally, we will also discuss future promise and challenges of NGS-based MRD determination for clinical decision-making. In addition, we will present our real-life single-center experience with the commercially available NGS strategy LymphoTrack-MiSeq. Even with the limitation of a limited number of patients, our results confirm the LymphoTrack-MiSeq platform as a cost-effective, readily available, and standardized workflow with a sensitivity of 10-5. Our real-life data also confirm that achieving MRD negativity is an important prognostic factor in MM. [ABSTRACT FROM AUTHOR]

Published
2022
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7. Progressive Down Regulation of JAK-STAT, Cell Cycle, and ABC Transporter Genes in CD34+/Lin- Cells of Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients at Diagnosis Vs. 12 Months of Nilotinib Treatment Vs. Healthy Subjects

Author

Trojani, Alessandra, primary, Pungolino, Ester, additional, Rossi, Giuseppe, additional, D'adda, Mariella, additional, Bossi, Luca Emanuele, additional, Baruzzo, Giacomo, additional, Di Camillo, Barbara, additional, Perego, Alessandra, additional, Turrini, Mauro, additional, Elena, Chiara, additional, Borin, Lorenza Maria, additional, Iurlo, Alessandra, additional, Malato, Simona, additional, Spina, Francesco, additional, Latargia, Maria Luisa, additional, Spedini, Pierangelo, additional, Artale, Salvatore, additional, Anghilieri, Michela, additional, Carraro, Maria Cristina, additional, Bucelli, Cristina, additional, De Canal, Gabriella, additional, Morra, Enrica, additional, and Cairoli, Roberto, additional

Published
2019
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8. Nilotinib interferes with cell cycle, ABC transporters and JAK-STAT signaling pathway in CD34+/lin- cells of patients with chronic phase chronic myeloid leukemia after 12 months of treatment

Author

Trojani, Alessandra, primary, Pungolino, Ester, additional, Dal Molin, Alessandra, additional, Lodola, Milena, additional, Rossi, Giuseppe, additional, D’Adda, Mariella, additional, Perego, Alessandra, additional, Elena, Chiara, additional, Turrini, Mauro, additional, Borin, Lorenza, additional, Bucelli, Cristina, additional, Malato, Simona, additional, Carraro, Maria Cristina, additional, Spina, Francesco, additional, Latargia, Maria Luisa, additional, Artale, Salvatore, additional, Spedini, Pierangelo, additional, Anghilieri, Michela, additional, Di Camillo, Barbara, additional, Baruzzo, Giacomo, additional, De Canal, Gabriella, additional, Iurlo, Alessandra, additional, Morra, Enrica, additional, and Cairoli, Roberto, additional

Published
2019
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9. Deferasirox in the management of iron‐overload in patients with myelofibrosis: a multicentre study from the Rete Ematologica Lombarda ( IRON ‐M study)

Author

Elli, Elena M., primary, Iurlo, Alessandra, additional, Aroldi, Andrea, additional, Caramella, Marianna, additional, Malato, Simona, additional, Casartelli, Elena, additional, Maffioli, Margherita, additional, Gardellini, Angelo, additional, Carraro, Maria C., additional, D'Adda, Mariella, additional, Polverelli, Nicola, additional, Rossi, Marianna, additional, Orofino, Nicola, additional, Carrer, Andrea, additional, Gambacorti‐Passerini, Carlo, additional, Antolini, Laura, additional, and Passamonti, Francesco, additional

Published
2019
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10. Nilotinib Deregulates Cell Cycle Checkpoints, ABC Transporters Genes and JAK-STAT Signaling Pathway of CD34+/Lin- Cells in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients after 12 Months of Treatment

Author

Lodola Milena, Morra Enrica, Giacomo Baruzzo, Anghilieri Michela, Carraro Maria Cristina, Lorenza Borin, Elena Chiara, Pungolino Ester, Rossi Giuseppe, Artale Salvatore, Gabriella De Canal, Turrini Mauro, Spina Francesco, Bucelli Cristina, Trojani Alessandra, D'adda Mariella, Malato Simona, Perego Alessandra, Iurlo Alessandra, Spedini Pierangelo, Alessandra Dal Molin, Cairoli Roberto, Maria Luisa Latargia, Trojani, A, Pungolino, E, Rossi, G, D'Adda, M, Lodola, M, Dal Molin, A, Baruzzo, G, Perego, A, Turrini, M, Elena, C, Borin, L, Iurlo, A, Malato, S, Spina, F, Latargia, M, Spedini, P, Artale, S, Anghilieri, M, Cristina, C, Bucelli, C, De Canal, G, Morra, E, and Cairoli, R

Subjects
Oncology, education.field_of_study, medicine.medical_specialty, business.industry, Immunology, Population, CD34, Myeloid leukemia, Cell Biology, Hematology, Cell cycle, Biochemistry, Gene expression profiling, medicine.anatomical_structure, Nilotinib, Internal medicine, medicine, Bone marrow, Stem cell, education, business, medicine.drug
Abstract

Introduction Chronic myeloid leukemia (CML) is a stem cell disease characterized by the constitutive activity of the oncoprotein BCR-ABL that activates multiple signal transduction pathways. Tyrosine-kinase inhibitor (TKI) nilotinib successfully inhibits the activation and the proliferative function of BCR-ABL in patients with CP-CML. Despite the success of nilotinib, some patients become refractory suggesting the presence of a population of Philadelphia positive (Ph+) quiescent stem cells escaping the drug activity. Thus, the molecular mechanisms underlying CML remain poorly understood. In this study, we enrolled 87 CP-CML patients (Pungolino et. al. Am J Hematol. 2018). Samples were collected on the behalf of the Rete Ematologica Lombarda (REL) the PhilosoPhi34 study (EudraCT: 2012-005062-34), which included 15 centers from Italy. We undertook gene expression profiling (GEP) of selected bone marrow (BM) CD34+/lin- cells of 80 patients at diagnosis vs. the same patients after 12 months of nilotinib to investigate gene expression changes induced by the treatment. Methods We isolated CD34+/lin- cells from BM samples in 87 patients at diagnosis whereas the same cells were also selected from 80/87 patients after 3, 6 and 12 months of nilotinib (Trojani et. al. Cancer Biomark. 2017). BM mononuclear cells (MNCs) as well as BM CD34+/lin- cells of all 80 CML patients were counted at diagnosis and during the treatment with nilotinib (at 3, 6, and 12 months, respectively). Standard FISH tested isolated BM CD34/lin- cells for the 87 patients at diagnosis, and for 80/87 patients after 3, 6 and 12 months of nilotinib treatment, respectively. Therefore, we performed GEP analyses of selected BM CD34+/lin- cells of 80/87 patients at diagnosis vs. the same patients after 12 months of nilotinib treatment. Then, we executed bioinformatic preprocessing and correction for batch effects on raw microarray data. Finally, we conducted differential expression analysis and significantly perturbed genes were subjected to functional clustering. Results We observed a wide variability of the number of BM MNCs as well as the number of the BM CD34+/lin- cells among the 80 CP-CML patients at diagnosis and after 3, 6 and 12 months of nilotinib for each patient (Table 1). Figure 1 showed that the number of the BM CD34+/lin- cells dramatically decreased between the diagnosis and after 3 as well as 6 months of nilotinib. We noticed that the BM CD34+/lin- cells slightly increased between 6 and 12 months of nilotinib which might be caused by the gradual repopulation of the normal CD34+/lin- cells in the bone marrow as FISH results suggested. FISH analysis detected CD34+/lin- Ph+ cells in 87 CP-CML patients at diagnosis. No positive Ph+ nuclei were detected on CD34+/lin- cells of 79/80 patients after 12 months of treatment (to categorize a sample as negative, at least 200 nuclei were examined). All of these 79 patients achieved at least complete cytogenetic response. 1/80 patient relapsed at 12 months. We conducted GEP analyses on 78 subjects because, due to experimental issues, two patients were not considered for differential expression analyses, as the microarray CEL files of the 12 months' samples were corrupted and missed probe intensities for most of the probes. GEP analyses determined 2,959 significantly differently expressed probes between diagnosis and after 12 months of nilotinib treatment. Functional clustering identified some pathways significantly enriched between diagnosis and 12 months of nilotinib. Among these pathways, we found that ABCC4, ABCC5, and ABCD3 genes associated with ATP-binding cassette (ABC) transporters were up regulated at diagnosis. GEP results highlighted that 26 genes belonging to cell cycle, mitosis, DNA damage and repair were over expressed at diagnosis. Moreover, GEP data demonstrated that JAK-STAT signaling pathway was deregulated: JAK2, IL7, STAM, PIK3CA, PTPN11, RAF1, SOS1 were over expressed whereas IL22RA1 was under expressed at diagnosis vs. 12 months of nilotinib, respectively. Conclusions In summary, we reported that BM CD34+/lin- cells from CP-CML patients after 12 months of nilotinib were characterized by changes of expression of genes involved in cell cycle checkpoints and mitosis, ABC transporters genes that pump drugs outside form the cells, and JAK-STAT signaling pathway genes responsible for the proliferation, differentiation and cell survival in CML. Disclosures Rossi: Teva: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Jazz: Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria; Mundipharma: Honoraria; BMS: Honoraria; Sandoz: Honoraria; Gilead: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees.

Published
2018

11. Genes and Pathways Dysregulated by Nilotinib Treatment in Bone Marrow CD34+/Lin- Cells of Patients with Chronic-Phase Chronic Myeloid Leukaemia

Author

Alessandra Trojani, Ester Pungolino, Alessandra Dal Molin, Milena Lodola, Gabriella De Canal, Giuseppe Rossi, Mariella D’Adda, Alessandra Perego, Ester Orlandi, Malato Simona, Mauro Turrini, Lorenza Borin, Alessandra Iurlo, Maria Luisa Latargia, Maria Cristina Carraro, Francesco Spina, Salvatore Artale, Michela Anghilieri, Francesco Lanza, Enrica Morra, Cairoli Roberto, Alessandra, T, Ester, P, Alessandra Dal, M, Milena, L, Gabriella De, C, Giuseppe, R, Mariella, D, Alessandra, P, Ester, O, Malato, S, Mauro, T, Lorenza, B, Alessandra, I, Maria Luisa, L, Maria Cristina, C, Francesco, S, Salvatore, A, Michela, A, Francesco, L, Enrica, M, and Cairoli, R

Subjects
Bone marrow CD34+/Lin- cells, chronic myeloid leukaemia (CML), genes and pathways, nilotinib
Published
2018

12. Jak-2 and Nfkbia Gene Expression Play a Strategic Role in Chronic Myeloid Leukemia (CML) Molecular Response during Early Nilotinib Treatment: The PhilosoPhi34 Data

Author

Pungolino, Ester, primary, D'adda, Mariella, additional, Trojani, Alessandra, additional, Perego, Alessandra, additional, Elena, Chiara, additional, Iurlo, Alessandra, additional, Malato, Simona, additional, Turrini, Mauro, additional, De Canal, Gabriella, additional, Borin, Lorenza, additional, Lodola, Milena, additional, Caramella, Marianna, additional, Artale, Salvatore, additional, Spina, Francesco, additional, Latargia, Maria Luisa, additional, Anghilieri, Michela, additional, Spedini, Pierangelo, additional, Carraro, Mariacristina, additional, Di Camillo, Barbara, additional, Gramegna, Doriana, additional, Pioltelli, Maria Luisa, additional, Rossi, Giuseppe, additional, Morra, Enrica, additional, and Cairoli, Roberto, additional

Published
2018
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13. Nilotinib Deregulates Cell Cycle Checkpoints, ABC Transporters Genes and JAK-STAT Signaling Pathway of CD34+/Lin- Cells in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients after 12 Months of Treatment

Author

Trojani, Alessandra, primary, Pungolino, Ester, additional, Rossi, Giuseppe, additional, D'adda, Mariella, additional, Lodola, Milena, additional, Dal Molin, Alessandra, additional, Baruzzo, Giacomo, additional, Perego, Alessandra, additional, Turrini, Mauro, additional, Elena, Chiara, additional, Borin, Lorenza Maria, additional, Iurlo, Alessandra, additional, Malato, Simona, additional, Spina, Francesco, additional, Latargia, Maria Luisa, additional, Spedini, Pierangelo, additional, Artale, Salvatore, additional, Anghilieri, Michela, additional, Maria Cristina, Carraro, additional, Bucelli, Cristina, additional, De Canal, Gabriella, additional, Morra, Enrica, additional, and Cairoli, Roberto, additional

Published
2018
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14. Combining Imatinib-Following-Nilotinib Treatment in First Line Therapy for Chronic Phase Chronic Myeloid Leukemia. Update from the PhilosoPhi34 Study at 24 Months of Follow-up

Author

Pioltelli, Maria Luisa, primary, Pungolino, Ester, additional, D'adda, Mariella, additional, Elena, Chiara, additional, Borin, Lorenza Maria, additional, Perego, Alessandra, additional, Iurlo, Alessandra, additional, Trojani, Alessandra, additional, Turrini, Mauro, additional, Caramella, Marianna, additional, Spedini, Pierangelo, additional, Malato, Simona, additional, Spina, Francesco, additional, Artale, Salvatore, additional, Carraro, Mariacristina, additional, Orofino, Nicola, additional, Anghilieri, Michela, additional, Farina, Mirko, additional, Latargia, Maria Luisa, additional, Rossi, Giuseppe, additional, Morra, Enrica, additional, and Cairoli, Roberto, additional

Published
2018
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15. Genes and Pathways Dysregulated by Nilotinib Treatment in Bone Marrow CD34+/Lin- Cells of Patients with Chronic-Phase Chronic Myeloid Leukaemia

Author

Alessandra, T, Ester, P, Alessandra Dal, M, Milena, L, Gabriella De, C, Giuseppe, R, Mariella, D, Alessandra, P, Ester, O, Malato, S, Mauro, T, Lorenza, B, Alessandra, I, Maria Luisa, L, Maria Cristina, C, Francesco, S, Salvatore, A, Michela, A, Francesco, L, Enrica, M, Cairoli, R, Alessandra Trojani, Ester Pungolino, Alessandra Dal Molin, Milena Lodola, Gabriella De Canal, Giuseppe Rossi, Mariella D’Adda, Alessandra Perego, Ester Orlandi, Malato Simona, Mauro Turrini, Lorenza Borin, Alessandra Iurlo, Maria Luisa Latargia, Maria Cristina Carraro, Francesco Spina, Salvatore Artale, Michela Anghilieri, Francesco Lanza, Enrica Morra, Cairoli Roberto, Alessandra, T, Ester, P, Alessandra Dal, M, Milena, L, Gabriella De, C, Giuseppe, R, Mariella, D, Alessandra, P, Ester, O, Malato, S, Mauro, T, Lorenza, B, Alessandra, I, Maria Luisa, L, Maria Cristina, C, Francesco, S, Salvatore, A, Michela, A, Francesco, L, Enrica, M, Cairoli, R, Alessandra Trojani, Ester Pungolino, Alessandra Dal Molin, Milena Lodola, Gabriella De Canal, Giuseppe Rossi, Mariella D’Adda, Alessandra Perego, Ester Orlandi, Malato Simona, Mauro Turrini, Lorenza Borin, Alessandra Iurlo, Maria Luisa Latargia, Maria Cristina Carraro, Francesco Spina, Salvatore Artale, Michela Anghilieri, Francesco Lanza, Enrica Morra, and Cairoli Roberto

Published
2018

16. Wide-transcriptome analysis and cellularity of bone marrow CD34+/lin- cells of patients with chronic-phase chronic myeloid leukemia at diagnosis vs. 12 months of first-line nilotinib treatment

Author

Trojani, Alessandra, primary, Pungolino, Ester, additional, Rossi, Giuseppe, additional, D’Adda, Mariella, additional, Lodola, Milena, additional, Camillo, Barbara Di, additional, Perego, Alessandra, additional, Turrini, Mauro, additional, Orlandi, Ester, additional, Borin, Lorenza, additional, Iurlo, Alessandra, additional, Malato, Simona, additional, Spina, Francesco, additional, Latargia, Maria Luisa, additional, Lanza, Francesco, additional, Artale, Salvatore, additional, Anghilieri, Michela, additional, Carraro, Maria Cristina, additional, Canal, Gabriella De, additional, Morra, Enrica, additional, and Cairoli, Roberto, additional

Published
2017
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17. The REL-Protocol PhilosoPhi34 - an Open Label, Single Arm, Phase II Study of Nilotinib 300 Mg BID in Newly Diagnosed Chronic Phase Chronic Myeloid Leukaemia (CML) Patients - Confirms Early Clearance of Bone Marrow CD34+/Lin-Ph+ Cells

Author

Pungolino, Ester, primary, De Canal, Gabriella, additional, D'adda, Mariella, additional, Perego, Alessandra, additional, Turrini, Mauro, additional, Orlandi, Ester Maria, additional, Trojani, Alessandra, additional, Borin, Lorenza, additional, Iurlo, Alessandra, additional, Latargia, Maria Luisa, additional, Malato, Simona, additional, Carraro, Maria Cristina, additional, Brusorio, Stefania, additional, Elena, Chiara, additional, Spina, Francesco, additional, Lodola, Milena, additional, Artale, Salvatore, additional, Anghilieri, Michela, additional, Bucelli, Cristina, additional, Pioltelli, Maria Luisa, additional, Cantoni, Silvia, additional, Rossi, Giuseppe, additional, Morra, Enrica, additional, and Cairoli, Roberto, additional

Published
2016
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18. Clonal hematopoiesis in patients with autoimmune thrombocytopenia: an international multicenter study

Author

Fattizzo, Bruno, Marchetti, Alfredo, Bosi, Alessandro, Gurnari, Carmelo, Giannotta, Juri Alessandro, Pedone, Giacinto Luca, Rossi, Elena, Carrai, Valentina, Guido, Andrea, Brioschi, Filippo, Carpenedo, Monica, Crugnola, Monica, Caramazza, Domenica, Leuzzi, Livia, Marchetti, Monia, Merati, Gabriele, Malato, Simona, Vianello, Fabrizio, Patriarca, Andrea, Awada, Hussein, Bortolotti, Marta, Canzi, Marta, Bolli, Niccolò, Capecchi, Marco, Chen, Frederick, Artoni, Andrea, Maciejewski, Jaroslaw P., and Barcellini, Wilma

Abstract

•Of 167 patients with ITP, 18.5% had somatic mutations typical of clonal hemopoiesis, 68% high-risk variants, and 8 multiple mutations.•Mutated patients were more frequently older males, with a shorter time from first to second-line therapy, and had a higher thrombotic risk.

Published
2024
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19. GEP Analyses of Bone Marrow CD34+/Lin- Cells of Chronic Phase CML Patients at Diagnosis Identified Different Sets of Genes Associated to the Molecular Response after 3 and 6 Months of First-Line Nilotinib Treatment

Author

Trojani, Alessandra, primary, Pungolino, Ester, additional, Lodola, Milena, additional, Di Camillo, Barbara, additional, D'Adda, Mariella, additional, Perego, Alessandra, additional, Turrini, Mauro, additional, Elena, Chiara, additional, Iurlo, Alessandra, additional, Buccelli, Cristina, additional, Malato, Simona, additional, Spina, Francesco, additional, Latargia, Maria Luisa, additional, Lanza, Francesco, additional, Pauli, Sergio, additional, Anghilieri, Michela, additional, Carraro, Maria Cristina, additional, Morra, Enrica, additional, and Cairoli, Roberto, additional

Published
2015
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20. REL-Protocol PhilosoPhi34: An Open Label, Single Arm, Phase II Study of Nilotinib 300 Mg BID in Newly Diagnosed Chronic Phase Chronic Myeloid Leukaemia Patients, to Study the Disappearance of CD34+/Lin-Ph+ Cells from Bone Marrow during Treatment. Preliminary Data

Author

Pungolino, Ester, primary, Rossi, Giuseppe, additional, Mura, Maria Angela, additional, Perego, Alessandra, additional, Orlandi, Ester Maria, additional, Turrini, Mauro, additional, Borin, Lorenza, additional, Capucci, Maria Adele, additional, Iurlo, Alessandra, additional, Trojani, Alessandra, additional, D'Adda, Mariella, additional, Spina, Francesco, additional, De Canal, Gabriella, additional, Pioltelli, Maria Luisa, additional, Latargia, Maria Luisa, additional, Pauli, Sergio, additional, Elena, Chiara, additional, Brusorio, Stefania, additional, Lanza, Francesco, additional, Malato, Simona, additional, Anghilieri, Michela, additional, Carraro, Maria C, additional, Morra, Enrica, additional, and Cairoli, Roberto, additional

Published
2015
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21. Gene Expression Profiling and Cellularity of Bone Marrow CD34+/Lin- Cells of Patients with Chronic-Phase Chronic Myeloid Leukemia at Diagnosis Vs. 12 Months of First-Line Nilotinib Treatment

Author

Trojani, Alessandra, Pungolino, Ester, Rossi, Giuseppe, D'Adda, Mariella, Lodola, Milena, Di Camillo, Barbara, Perego, Alessandra, Turrini, Mauro, Orlandi, Ester Maria, Borin, Lorenza Maria, Iurlo, Alessandra, Malato, Simona, Spina, Francesco, Latargia, Maria Luisa, Lanza, Francesco, Artale, Salvatore, Anghilieri, Michela, Maria Cristina, Carraro, Bucelli, Cristina, De Canal, Gabriella, Morra, Enrica, and Cairoli, Roberto

Published
2017
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22. Preliminary Experience of Imatinib after Nilotinib in the First Line Treatment of Chronic Myeloid Leukemia

Author

Pungolino, Ester, D'adda, Mariella, Perego, Alessandra, Orlandi, Ester Maria, Turrini, Mauro, Borin, Lorenza Maria, Iurlo, Alessandra, Artale, Salvatore, Latargia, Maria Luisa, Anghilieri, Michela, Malato, Simona, Trojani, Alessandra, Spina, Francesco, Maria Cristina, Carraro, Pioltelli, Maria Luisa, Elena, Chiara, Bucelli, Cristina, Spedini, Pierangelo, Rossi, Giuseppe, Morra, Enrica, and Cairoli, Roberto

Published
2017
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23. Refined Disease Risk Index (DRI) and Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) Predict Survival after Haploidentical Stem Cell Transplantation: A Comparative Study with EBMT Risk Score in 220 Consecutive Patients

Author

Mara Morelli, Sarah Marktel, Massimo Bernardi, Raffaella Greco, Maria Teresa Lupo-Stanghellini, Fabio Giglio, Luca Vago, Sara Mastaglio, Carlo Messina, Forcina Alessandra, Jacopo Peccatori, Francesca Lunghi, Matteo Carrabba, Magda Marcatti, Elisa Sala, Simona Piemontese, Andrea Assanelli, Consuelo Corti, Malato Simona, Francesca Pavesi, Fabio Ciceri, Francesca Lorentino, Elena Guggiari, Lupo-Stanghellini, Mt, Sala, E, Piemontese, S, Morelli, M, Greco, R, Marcatti, M, Assanelli, A, Carrabba, Mg, Alessandra, F, Mastaglio, S, Marktel, S, Lorentino, F, Lunghi, F, Guggiari, E, Giglio, F, Simona, M, Pavesi, F, Messina, C, Vago, L, Corti, C, Bernardi, M, Peccatori, J, and Ciceri, F

Subjects
medicine.medical_specialty, Framingham Risk Score, business.industry, Immunology, Context (language use), Retrospective cohort study, Cell Biology, Hematology, Total body irradiation, Treosulfan, Biochemistry, Surgery, Transplantation, Clinical trial, surgical procedures, operative, Internal medicine, medicine, business, Risk assessment, medicine.drug
Abstract

Background Optimization of pre-transplant risk assessment is a crucial issue to improve the allo-HSCT decision making process. Actually 3 major algorithms are in use in clinical practice: the EBMT risk score, the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) score and - more recently introduced - the refined Disease Risk Index (DRI). DRI was defined to calibrate HSCT outcome across studies and centers. It was developed as a tool to assign patients into risk groups based on disease type and status at the time of transplantation. The aim of the DRI is to provide a robust tool that can be used for prognostication, for the analysis and interpretation of retrospective data, whether conducted in single-center, multicenter, or registry settings, or within the context of the federally mandated center outcome reporting. The DRI can also be used for the stratification of patients entering prospective HCT clinical trials. DRI is not a fixed tool but instead it was conceived to be refined by the transplant community as new information becomes available. Here we are presenting the results of a retrospective study designed to evaluate the 3 aforementioned score in stratification and prognostication of transplant outcome after a haploidentical HSCT (haplo-HSCT). Patients and Methods We included 220 adult patients (pts - 138 male, 82 female) who underwent a haplo-HSCT for hematologic malignancies, between 2006 and 2014 and were reported to our Institutional database. Risk assessment score and outcome analysis included all consecutive pts receiving an haplo-HSCT as 1st allogeneic transplantation. Pts receiving haplo-HSCT as 2nd or 3rd HSCT were excluded from the present analysis. Median age was 49 years (range, 15-77). The cohort included a broad representation of diseases (138/220 acute leukemia, 30 Hodgkin lymphoma); 62 pts were in complete remission at transplant, 158 were presenting active disease. Conditioning regimens mostly rely upon the combination of treosulfan plus fludarabine (201/220) and total body irradiation (range 200 - 400 cGy) was utilized in 52 patients. GVHD prophylaxis consisted mostly of an mTor inhibitor (rapamycin) combined with mycophenolate mofetil. The majority of patients received peripheral blood stem cells from a family haploidentical donor as stem cell source, while only 4 patients received bone marrow transplant. A written consent was given by pts allowing the use of medical records for research in accordance with the Declaration of Helsinki. Results The median follow-up for survivors was 37 months (r 6-107). The overall survival (OS) at 2-y was 35% and the transplant related mortality at 100-days 23%. The 2y OS according to EBMT / HCT-CI / DRI risk score are reported in table 1.a and figure 1. The evaluation of the HCT-CI impact after DRI stratification was able to show a significant difference in outcome showing better survival for pts with low DRI score and low HCT-CI score as expected (table 1.b). Discussion Refined DRI score and HCT-CI score predict survival after haplo-HSCT. The integrated application of refined DRI and HCT-CI may improve the definition of transplant eligibility for pts candidate to allogeneic HSCT form alternative donors including family haploidentical source. Table 1a. EBMT score 0-3 % pts 4-5 %pts > 5 %pts p 51% 17 34% 51 27% 32 0.07 HCT-CI score 0-2 3-4 >/= 5 48% 59 36% 31 0% 10 0.0001 DRI score Low-Intermediate High Very-High 61% 32 27% 51 5% 17 0.0001 Table 1b. HCT-CI 0-4 HCT-CI >/=5 p DRILow-Intermediate 64% 0% 0.0001 DRIHigh-Very High 29% 0% Figure 1. Figure 1. Disclosures No relevant conflicts of interest to declare.

Published
2015
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24. Microarray of Bone Marrow CD34+/Lin- Cells from Patients with Chronic Myeloid Leukemia (CML)

Author

Trojani, Alessandra, primary, Lodola, Milena, additional, Di Camillo, Barbara, additional, Rossi, Giuseppe, additional, Capucci, Adele, additional, Perego, Alessandra, additional, Pogliani, Enrico Maria, additional, Orlandi, Ester, additional, Iurlo, Alessandra, additional, Malato, Simona, additional, Corradini, Paolo, additional, Cairoli, Roberto, additional, Bregni, Marco, additional, Pauli, Sergio, additional, Morra, Enrica, additional, and Pungolino, Ester, additional

Published
2014
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25. Gene Expression Profiling of CD34+/Lin- Cells of Patients with Chronic Myeloid Leukemia at Diagnosis and after 12 Months of Nilotinib

Author

Trojani, Alessandra, primary, Lodola, Milena, additional, Di Camillo, Barbara, additional, Rossi, Giuseppe, additional, Capucci, Adele, additional, Perego, Alessandra, additional, Pogliani, Enrico Maria, additional, Orlandi, Ester, additional, Iurlo, Alessandra, additional, Malato, Simona, additional, Corradini, Paolo, additional, Cairoli, Roberto, additional, Bregni, Marco, additional, Artale, Salvatore, additional, Morra, Enrica, additional, and Pungolino, Ester, additional

Published
2014
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26. Human Herpes Virus-6 and Clinical Manifestations After Allogeneic Hematopoietic Stem Cell Transplantation

Author

Greco, Raffaella, primary, Lorentino, Francesca, additional, Clerici, Daniela, additional, Matteazzi, Francesca, additional, Forcina, Alessandra, additional, Vago, Luca, additional, Malato, Simona, additional, Stanghellini, Maria Teresa Lupo, additional, Carrabba, Matteo, additional, Assanelli, Andrea, additional, Marcatti, Magda, additional, Bernardi, Massimo, additional, Bordignon, Claudio, additional, Ciceri, Fabio, additional, and Corti, Consuelo, additional

Published
2011
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27. Treosulfan-Based Myeloablative Conditioning for Autologous Stem Cell Transplantation In Elderly Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome: Data of Feasibility and Efficacy In 10 Patients.

Author

Bernardi, Massimo, primary, Messina, Carlo, additional, Tassara, Michela, additional, Crotta, Alessandro, additional, Giglio, Fabio, additional, Assanelli, Andrea, additional, Clerici, Daniela, additional, Corti, Consuelo, additional, Marcatti, Magda, additional, Malato, Simona, additional, Forno, Barbara, additional, Peccatori, Jacopo, additional, and Ciceri, Fabio, additional

Published
2010
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28. Bone-to-Bone Stem Cell Infusion In Graft Failure After Haploidentical Hematopoietic Stem Cell Transplantation: Safety and Feasibility. Three Case Report

Author

Giglio, Fabio, primary, Malato, Simona, additional, Clerici, Daniela, additional, Messina, Carlo, additional, Mastaglio, Sara, additional, Claudiani, Simone, additional, Gentner, Bernhard, additional, Zambelli, Matilde, additional, Assanelli, Andrea, additional, Matozzo, Vincenzo, additional, Corti, Consuelo, additional, Bernardi, Massimo, additional, Peccatori, Jacopo, additional, and Ciceri, Fabio, additional

Published
2010
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29. Effect of Related and Unrelated Donor Haemopoietic Stem-Cell Transplantation on Outcome In Adults with High Risk Acute Leukemia: An Intention-to-Treat Analysis at a Single Center Institution

Author

Lupo-Stanghellini, Maria Teresa, primary, Marcatti, Magda, additional, Coppola, Milena, additional, Forno, Barbara, additional, Bitetti, Cinzia, additional, Sala, Elisa, additional, Assanelli, Andrea, additional, Greco, Raffaella, additional, Lunghi, Francesca, additional, Crotta, Alessandro, additional, Tassara, Michela, additional, Calbi, Valeria, additional, Matteazzi, Francesca, additional, Guggiari, Elena, additional, Carrabba, Matteo, additional, Camba, Lionello, additional, Clerici, Daniela, additional, Malato, Simona, additional, Marktel, Sarah, additional, Fleischhauer, Katharina, additional, Bonini, Chiara, additional, Bordignon, Claudio, additional, Corti, Consuelo, additional, Bernardi, Massimo, additional, Peccatori, Jacopo, additional, and Ciceri, Fabio, additional

Published
2010
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30. Implementation of An Alternative Donor Option Is Prerequisite for a Good Intention-to-Treat (ITT) In Patients In Need of Allogeneic Transplantation: Analysis of 410 Patients

Author

Lupo-Stanghellini, Maria Teresa, primary, Forno, Barbara, additional, Marcatti, Magda, additional, Bitetti, Cinzia, additional, Coppola, Milena, additional, Assanelli, Andrea, additional, Greco, Raffaella, additional, Lunghi, Francesca, additional, Tassara, Michela, additional, Guggiari, Elena, additional, Carrabba, Matteo, additional, Matteazzi, Francesca, additional, Camba, Lionello, additional, Clerici, Daniela, additional, Malato, Simona, additional, Marktel, Sarah, additional, Bonini, Chiara, additional, Bordignon, Claudio, additional, Corti, Consuelo, additional, Bernardi, Massimo, additional, Peccatori, Jacopo, additional, and Ciceri, Fabio, additional

Published
2010
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31. Quantitative Real-Time PCR Detection of Wilms' Tumor Gene (WT1) Transcript in Autologous Peripheral Blood Stem Cell (PBSC) Products Predict the Risk of Acute Myeloid Leukaemia (AML) Relapse After Autologous Transplantation (ASCT).

Author

Messina, Carlo, primary, Tresoldi, Cristina, additional, Crotta, Alessandro, additional, Tassara, Michela, additional, Malato, Simona, additional, Forno, Barbara, additional, Marcatti, Magda, additional, Peccatori, Jacopo, additional, Corti, Consuelo, additional, Fleischhauer, Katharina, additional, Bordignon, Claudio, additional, Ciceri, Fabio, additional, and Bernardi, Massimo, additional

Published
2009
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32. Allogeneic Transplantation with a Treosulfan-Fludarabine Conditioning Regimen Is Feasible and Effective in Elderly Patients with Refractory or Relapsed Acute Myeloid Leukaemia (AML) and Myelodysplastic Syndrome (MDS); Preliminary Results From a Single Center Experience.

Author

Bernardi, Massimo, primary, Peccatori, Jacopo, additional, Tassara, Michela, additional, Crotta, Alessandro, additional, Messina, Carlo, additional, Stanghellini, Maria Teresa Lupo, additional, Forno, Barbara, additional, Girlanda, Stefania, additional, Assanelli, Andrea, additional, Clerici, Daniela, additional, Mastaglio, Sara, additional, Ruggeri, Annalisa, additional, Malato, Simona, additional, Giglio, Fabio, additional, Corti, Consuelo, additional, Guggiari, Elena, additional, Carrabba, Matteo Giovanni, additional, Bonini, Chiara, additional, and Ciceri, Fabio, additional

Published
2009
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33. Rapamycin-Based GvHD Prophylaxis Is Effective in T-Cell Replete Unmanipulated Haploidentical Peripheral Stem Cell Transplantation for Advanced Haematological Malignancies: Results in 46 Patients.

Author

Peccatori, Jacopo, primary, Clerici, Daniela, additional, Messina, Carlo, additional, Forcina, Alessandra, additional, Bondanza, Attilio, additional, Crocchiolo, Roberto, additional, Stanghellini, Maria Teresa Lupo, additional, Assanelli, Andrea, additional, Marcatti, Magda, additional, Giglio, Fabio, additional, Claudiani, Simone, additional, Mastaglio, Sara, additional, Malato, Simona, additional, Crotta, Alessandro, additional, Battaglia, Manuela, additional, Ronchi, Paola, additional, Gattillo, Salvatore, additional, Rossini, Silvano, additional, Corti, Consuelo, additional, Bernardi, Massimo, additional, Marktel, Sarah, additional, Bernardo, Maria Ester, additional, Bonini, Chiara, additional, Roncarolo, Maria Grazia, additional, Locatelli, Franco, additional, and Ciceri, Fabio, additional

Published
2009
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34. WT1 Transcripts Is a Powerful Leukemia Marker to Predict Early Relapse After Allogeneic Haematopoietic Stem Cell Transplantation.

Author

Messina, Carlo, primary, Tresoldi, Cristina, additional, Stanghellini, Maria Teresa Lupo, additional, Crotta, Alessandro, additional, Girlanda, Stefania, additional, Coppola, Milena, additional, Piemontese, Simona, additional, Greco, Raffaella, additional, Malato, Simona, additional, Forno, Barbara, additional, Assanelli, Andrea, additional, Clerici, Daniela, additional, Mastaglio, Sara, additional, Giglio, Fabio, additional, Ventre, Marta Bruno, additional, Lunghi, Francesca, additional, Guggiari, Elena, additional, Carrabba, Matteo Giovanni, additional, Marcatti, Magda, additional, Corti, Consuelo, additional, Bonini, Chiara, additional, Fleischhauer, Katharina, additional, Peccatori, Jacopo, additional, Bordignon, Claudio, additional, Ciceri, Fabio, additional, and Bernardi, Massimo, additional

Published
2009
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35. Jak-2and Nfkbia Gene Expression Play a Strategic Role in Chronic Myeloid Leukemia (CML) Molecular Response during Early Nilotinib Treatment: The PhilosoPhi34 Data

Author

Pungolino, Ester, D'adda, Mariella, Trojani, Alessandra, Perego, Alessandra, Elena, Chiara, Iurlo, Alessandra, Malato, Simona, Turrini, Mauro, De Canal, Gabriella, Borin, Lorenza, Lodola, Milena, Caramella, Marianna, Artale, Salvatore, Spina, Francesco, Latargia, Maria Luisa, Anghilieri, Michela, Spedini, Pierangelo, Carraro, Mariacristina, Di Camillo, Barbara, Gramegna, Doriana, Pioltelli, Maria Luisa, Rossi, Giuseppe, Morra, Enrica, and Cairoli, Roberto

Abstract

BackgroundTargeted therapy with Tyrosine-Kinase-Inhibitors (TKIs) totally modified the course of treatment of Chronic Myeloid Leukemia (CML). The objectives and the needs of treatment have been modified during the last years and the discontinuation of therapy is now a feasible aim. However, a lot of biological data acquired in the last twenty years, showed that degree and mechanisms of Leukemic Stem Cells (LSCs) clearance during TKI treatment are not clearly established as well as the predictive criteria for a stable and prolonged Treatment Free Remission (TFR). The multicentre, prospective, single-arm PhilosoPhi34 study (EudraCT: 2012-005062-34) was designed by the Rete Ematologica Lombarda (REL), to verify the in-vivo activity and time-course of first-line Nilotinib (NIL) therapy on Bone Marrow (BM) CD34+/lin-Ph+ cells clearance. An exploratory Gene Expression Profiling (GEP) study of CD34+/lin- cells at diagnosis and at 12 months (mos) of treatment, for the first 30 evaluable pts, was included. Preliminary GEP data suggested a correlation between different NFKBIAexpression at diagnosis and at 12 mos and the achievement of a deeper Molecular Response (MR) (Pungolino et al, AJH 2018).

Published
2018
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