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2. Ibrutinib for bridging to allogeneic hematopoietic cell transplantation in patients with chronic lymphocytic leukemia or mantle cell lymphoma: a study by the EBMT Chronic Malignancies and Lymphoma Working Parties

Author

Dreger, Peter, Michallet, Mauricette, Bosman, Paul, Dietrich, Sascha, Sobh, Mohamad, Boumendil, Ariane, Nagler, Arnon, Scheid, Christof, Cornelissen, Jan, Niederwieser, Dietger, Müller, Lutz, Vandenberghe, Elizabeth, Scortechini, Ilaria, Schoemans, Helene, Andersen, Niels S., Finke, Jürgen, Russo, Domenico, Ljungman, Per, Passweg, Jakob, van Gelder, Michel, Durakovic, Nadira, Labussiere-Wallet, Helene, Berg, Tobias, Wulf, Gerald, Bethge, Wolfgang, Bunjes, Donald, Stilgenbauer, Stefan, Canepari, Maria Elisa, Schaap, Michel, Fox, Christopher P., Kröger, Nicolaus, Montoto, Silvia, and Schetelig, Johannes

Published
2019
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3. Outcomes of Cord Blood Transplantation Using Reduced-Intensity Conditioning for Chronic Lymphocytic Leukemia: A Study on Behalf of Eurocord and Cord Blood Committee of Cellular Therapy and Immunobiology Working Party, Chronic Malignancies Working Party of the European Society for Blood and Marrow Transplantation, and the Societé Française de Greffe de Moelle et Therapie Cellulaire

Author

Xavier, Erick, Cornillon, Jérôme, Ruggeri, Annalisa, Chevallier, Patrice, Cornelissen, Jan J., Andersen, Niels S., Maillard, Natacha, Nguyen, Stephanie, Blaise, Didier, Deconinck, Eric, Veelken, Hendrik, Milpied, Noel, Van Gelder, Michel, Peffault de Latour, Regis, Gluckman, Eliane, Kröger, Nicolaus, Schetelig, Johannes, and Rocha, Vanderson

Published
2015
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5. Trends in survival and cure after allogeneic haematopoietic cell transplantation for acute myeloid leukaemia from 2000 to 2020: A Danish population‐based cohort study

Author

Gjærde, Lars K., primary, Jakobsen, Lasse H., additional, Juhl‐Christensen, Caroline, additional, Olesen, Gitte, additional, Petruskevicius, Irma, additional, Severinsen, Marianne T., additional, Marcher, Claus W., additional, Theilgaard‐Mönch, Kim, additional, Andersen, Niels S., additional, Friis, Lone S., additional, Kornblit, Brian, additional, Petersen, Søren L., additional, Schjødt, Ida, additional, and Sengeløv, Henrik, additional

Published
2022
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6. Trends in survival and cure after allogeneic haematopoietic cell transplantation for acute myeloid leukaemia from 2000 to 2020: A Danish population‐based cohort study.

Author

Gjærde, Lars K., Jakobsen, Lasse H., Juhl‐Christensen, Caroline, Olesen, Gitte, Petruskevicius, Irma, Severinsen, Marianne T., Marcher, Claus W., Theilgaard‐Mönch, Kim, Andersen, Niels S., Friis, Lone S., Kornblit, Brian, Petersen, Søren L., Schjødt, Ida, and Sengeløv, Henrik

Subjects
ACUTE myeloid leukemia, CELL transplantation, COHORT analysis, HEMATOPOIETIC stem cell transplantation, CORD blood
Published
2023
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7. Pulmonary function is a strong predictor of 2‐year overall survival and non‐relapse mortality after allogenic hematopoietic cell transplantation.

Author

Schierbeck, Frederikke, Mortensen, Jann, Andersen, Niels S., Friis, Lone S., Kornblit, Brian, Petersen, Søren L., Schjødt, Ida, and Sengeløv, Henrik

Subjects
HEMATOPOIETIC stem cell transplantation, OVERALL survival, UNIVARIATE analysis
Abstract

Objectives: The purpose of the study was to assess the validity of the hematopoietic cell transplantation‐specific comorbidity index (HCT‐CI) and of pulmonary comorbidity prior to HCT in terms of predicting non‐relapse mortality (NRM) and overall survival (OS). Methods: In this retrospective single‐center study of 663 consecutive adult recipients of HCT, we stratified patients into groups by pulmonary comorbidity: low‐risk, intermediate‐risk, and high‐risk. The predictive value of this pulmonary comorbidity score (PCS) was compared to HCT‐CI. Results: In univariate analysis, the HCT‐CI and the PCS were associated with OS after transplantation when comparing patients in high‐risk groups with patients in low‐risk groups. Using the PCS, the hazard ratios (HRs) of the 2‐year OS in the entire population and in the myeloablative conditioning (MAC) group were 1.98 (p <.001) and 3.27 (p <.001), respectively, whereas the HRs using the HCT‐CI were 1.83 (p <.001) and 2.57 (p =.002). The 2‐year NRM incidence in the three risk‐groups in the entire population was significant using both indexes. In the MAC group, the 2‐year NRM was significant using the PCS (p =.003), but not using the HCT‐CI (p =.23). Conclusions: Our study suggest that pulmonary function alone is a strong predictor of 2‐year OS and NRM after HCT. [ABSTRACT FROM AUTHOR]

Published
2023
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8. Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo–purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group

Author

Geisler, Christian H., Kolstad, Arne, Laurell, Anna, Andersen, Niels S., Pedersen, Lone B., Jerkeman, Mats, Eriksson, Mikael, Nordström, Marie, Kimby, Eva, Boesen, Anne Marie, Kuittinen, Outi, Lauritzsen, Grete F., Nilsson-Ehle, Herman, Ralfkiær, Elisabeth, Åkerman, Måns, Ehinger, Mats, Sundström, Christer, Langholm, Ruth, Delabie, Jan, Karjalainen-Lindsberg, Marja-Liisa, Brown, Peter, and Elonen, Erkki

Published
2008
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10. Nordic MCL2 trial update: six-year follow-up after intensive immunochemotherapy for untreated mantle cell lymphoma followed by BEAM or BEAC + autologous stem-cell support: still very long survival but late relapses do occur

Author

Geisler, Christian H., Kolstad, Arne, Laurell, Anna, Jerkeman, Mats, Räty, Riikka, Andersen, Niels S., Pedersen, Lone B., Eriksson, Mikael, Nordström, Marie, Kimby, Eva, Bentzen, Hans, Kuittinen, Outi, Lauritzsen, Grete F., Nilsson-Ehle, Herman, Ralfkiær, Elisabeth, Ehinger, Mats, Sundström, Christer, Delabie, Jan, Karjalainen-Lindsberg, Marja-Liisa, Brown, Peter, and Elonen, Erkki

Published
2012
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11. Sirolimus with CSP and MMF as GVHD prophylaxis for allogeneic transplantation with HLA antigen–mismatched donors

Author

Kornblit, Brian, primary, Storer, Barry E., additional, Andersen, Niels S., additional, Maris, Michael B., additional, Chauncey, Thomas R., additional, Petersdorf, Effie W., additional, Woolfrey, Ann E., additional, Flowers, Mary E. D., additional, Storb, Rainer, additional, Maloney, David G., additional, and Sandmaier, Brenda M., additional

Published
2020
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14. Centre characteristics and procedure-related factors have an impact on outcomes of allogeneic transplantation for patients with CLL: a retrospective analysis from the European Society for Blood and Marrow Transplantation (EBMT)

Author

Schetelig, Johannes, de Wreede, Liesbeth C., Andersen, Niels S., Moreno, Carol, van Gelder, Michel, Vitek, Antonin, Karas, Michal, Michallet, Mauricette, Machaczka, Maciej, Gramatzki, Martin, Beelen, Dietrich, Finke, Jürgen, Delgado, Julio, Volin, Liisa, Passweg, Jakob, Dreger, Peter, Schaap, Nicolaas, Wagner, Eva, Henseler, Anja, van Biezen, Anja, Bornhäuser, Martin, Iacobelli, Simona, Putter, Hein, Schönland, Stefan O., Kröger, Nicolaus, Esteve, Jordi, Ljungman, Per, de Witte, Theo, Stelljes, Matthias, Sierra, Jorge, Socié, Gerard, Ganser, Arnold, Wulf, Gerhard G., Deconinck, Eric, Faber, Edgar, Feguex, Nathalie, Gedde-Dahl, Tobias, Kolbe, Karin, Chalandon, Yves, Krüger, William, Huynh, Anne, Bourhis, Jean Henri, Schouten, Harry, Ribera Santasusana, Josep M., Interne Geneeskunde, MUMC+: MA Hematologie (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, and Chalandon, Yves

Subjects
Oncology, Male, Transplantation Conditioning, Cancer development and immune defence Radboud Institute for Molecular Life Sciences [Radboudumc 2], Chronic lymphocytic leukemia, Medizin, QUALITY MANAGEMENT-SYSTEM, Kaplan-Meier Estimate, risk factor analysis, GUIDELINES, Biochemistry, allogeneic stem cell transplantation, centre effects, chronic lymphocytic leukaemia, frailties, Transplantation Conditioning / methods, 0302 clinical medicine, Recurrence, Risk Factors, Leukemia, Lymphocytic, Chronic, B-Cell / mortality, Registries, Delivery of Health Care / statistics & numerical data, IBRUTINIB, ddc:616, 0303 health sciences, ALEMTUZUMAB, Hazard ratio, Hematopoietic Stem Cell Transplantation, Professional Practice, Hematology, Middle Aged, 3. Good health, Europe, 030220 oncology & carcinogenesis, ABT-199, Cohort, SURVIVAL, Alemtuzumab, Female, Europe / epidemiology, medicine.drug, Adult, medicine.medical_specialty, Allogeneic transplantation, Immunology, Lower risk, DIAGNOSIS, Settore MED/01 - Statistica Medica, 03 medical and health sciences, Leukemia, Lymphocytic, Chronic, B-Cell / therapy, Hematopoietic Stem Cell Transplantation / methods, Internal medicine, medicine, Humans, Karnofsky Performance Status, 030304 developmental biology, Aged, Retrospective Studies, business.industry, Proportional hazards model, CHRONIC LYMPHOCYTIC-LEUKEMIA, Retrospective cohort study, STEM-CELL TRANSPLANTATION, Cell Biology, medicine.disease, Leukemia, Lymphocytic, Chronic, B-Cell, Confidence interval, Surgery, Professional Practice / statistics & numerical data, Transplantation, business, Delivery of Health Care, 030215 immunology, RESPONSES
Abstract

Introduction:Even in the era of novel targeted therapies for the treatment of Chronic Lymphocytic Leukemia (CLL) patients, such as BTK, PI3K and BCL2 inhibitors, allogeneic hematopoietic stem cell transplantations (alloHCT) will remain an important treatment option for a subset of patients with very high risk CLL. The current study focused on the impact of center and procedure-related factors on outcomes after alloHCT, taking into account the impact of patient- and disease-related risk factors. Patients and Methods:Data of 684 CLL patients who received a first alloHCT between 2000 and 2011 were analyzed. Their data were collected as part of the EBMT CLL Data Quality Initiative. Outcomes of interest were Event-Free Survival (EFS) up to 5 years after transplantation and mortality in the first 100 days after alloHCT. Outcomes were analyzed by means of the Kaplan-Meier method and Cox proportional hazards models with a frailty (random effects) component to take into account unexplained center heterogeneity. The following factors describing center characteristics or the transplant procedure were analyzed: experience in alloHCT in general and, for CLL specifically, accreditation by the Joint Accreditation Committee-ISCT & EBMT (JACIE), Gross National Income (GNI)/capita based on purchasing power parity (PPP) (GNI/cap), donor type, donor-patient sex-match, type of conditioning, stem cell source and T-cell depletion (TCD). Results:Five-year EFS of the whole cohort was 37% (95% Confidence Interval, 33%-42%), Day-100 survival was 90% (88%-92%). Experience of the transplant center was measured by the number of all alloHCTs, and alloHCTs for patients with CLL respectively. The median total number of alloHCTs per center per year was 45 (range 0-169) and the median number of CLL alloHCTs was only 2 per center per year (range 0-19). Greater experience with transplantation of patients with CLL (Hazard Ratio (HR) 0.96 per additional transplant, p=0.002), JACIE accreditation (HR 0.7, p=0.045) and a higher GNI/cap (HR 0.4, 95% CI 0.2-0.96, p=0.04) showed a protective impact on 5-year EFS in the Cox model. In vivo TCD with alemtuzumab (HR 1.5 compared to no TCD, p=0.03) and a female donor for a male patient (HR 1.4 compared to a male donor for a male patient, p=0.02) were the only procedure-related factors significantly associated with EFS. Event-Free Survival after in vivo TCD with Anti-Thymocyte-Globulin or after ex vivo TCD was comparable to EFS without TCD (HR 0.9, 0.7-1.3, p=0.6; HR 0.9, 0.5-1.6, p=0.8). Non-myeloablative conditioning did not have a negative impact on 5-year EFS, and exposed patients to a lower risk of non-relapse mortality. Measured and unmeasured center characteristics did not have a significant impact on 100-day mortality. Even when correcting for patient-, procedure- and center-related characteristics, there was still significant variation in center outcome, expressed by center-specific HRs derived from the frailty models, ranging from 0.6 to 1.2. Their impact is illustrated in a model-based plot for EFS (see Figure) which shows outcomes for three reference patients with the same characteristics who would be transplanted in three centers with the same measured characteristics but with the highest, average and lowest HRs in the dataset. These unexplained center effects likely represent a mixture of differences which could apply to the location of the transplant center, unmeasured characteristics of the patient population transplanted at this center, selection criteria which were not reported and factors determining the success of the transplant procedure which might differ between centers. Conclusion: We have confirmed that both center- and procedure-related factors have a significant impact on the EFS of patients with CLL undergoing alloHCT. Our results may help to interpret outcomes of single or multicenter studies better. Since non-myeloablative conditioning did not have a negative impact on EFS and exposed patients to a lower risk of non-relapse mortality, this approach should be favored for future alloHCT for CLL. Probability of Event-Free Survival up to Five Years Post-HCT for three Reference Patients Contribution: J.S. designed the research and wrote the paper. L.C.d.W conducted the statistical analysis and produced the figure. Figure Figure. Disclosures Schetelig: Sanofi: Honoraria. Gramatzki:Janssen: Other: Travel/Accommodation/Expenses, Research Funding. Dreger:Gilead: Consultancy; Gilead: Speakers Bureau; Janssen: Consultancy; Novartis: Speakers Bureau; Novartis: Consultancy; Roche: Consultancy.

Published
2017

15. Ibrutinib for bridging to allogeneic hematopoietic cell transplantation in patients with chronic lymphocytic leukemia or mantle cell lymphoma: a study by the EBMT Chronic Malignancies and Lymphoma Working Parties

Author

Dreger, Peter, primary, Michallet, Mauricette, additional, Bosman, Paul, additional, Dietrich, Sascha, additional, Sobh, Mohamad, additional, Boumendil, Ariane, additional, Nagler, Arnon, additional, Scheid, Christof, additional, Cornelissen, Jan, additional, Niederwieser, Dietger, additional, Müller, Lutz, additional, Vandenberghe, Elizabeth, additional, Scortechini, Ilaria, additional, Schoemans, Helene, additional, Andersen, Niels S., additional, Finke, Jürgen, additional, Russo, Domenico, additional, Ljungman, Per, additional, Passweg, Jakob, additional, van Gelder, Michel, additional, Durakovic, Nadira, additional, Labussiere-Wallet, Helene, additional, Berg, Tobias, additional, Wulf, Gerald, additional, Bethge, Wolfgang, additional, Bunjes, Donald, additional, Stilgenbauer, Stefan, additional, Canepari, Maria Elisa, additional, Schaap, Michel, additional, Fox, Christopher P., additional, Kröger, Nicolaus, additional, Montoto, Silvia, additional, and Schetelig, Johannes, additional

Published
2018
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16. Ibrutinib for Bridging to Allogeneic Hematopoietic Stem Cell Transplantation (alloHCT) in Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL) Is Safe and Effective: First Results of a Survey By the Chronic Malignancy and the Lymphoma Working Parties of the EBMT

Author

Dreger, Peter, primary, Michallet, Mauricette, additional, Hoek, Jennifer, additional, Boumendil, Ariane, additional, Sobh, Mohamad, additional, Muller, Lutz, additional, Vandenberghe, Elisabeth A., additional, Scortechini, Ilaria, additional, Andersen, Niels S., additional, Finke, Jurgen, additional, Russo, Domenico, additional, Passweg, Jakob R, additional, Schoemans, Helene, additional, Durakovic, Nadira, additional, Labussiere, Helene, additional, Berg, Tobias, additional, Niederwieser, Dietger, additional, Bethge, Wolfgang, additional, Mordini, Nicola, additional, van Gelder, Michel, additional, Schaap, Nicolaas PM, additional, Kroger, Nicolaus, additional, Montoto, Silvia, additional, and Schetelig, Johannes, additional

Published
2016
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17. Molecular Monitoring and Tailored Strategy with Pre-Emptive Rituximab Treatment for Molecular Relapse; Results from the Nordic Mantle Cell Lymphoma Studies (MCL2 and MCL3) with Median Follow-up of 8.5 Years

Author

Kolstad, Arne, primary, Pedersen, Lone B, additional, Eskelund, Christian Winther, additional, Husby, Simon, additional, Grønbæk, Kirsten, additional, Jerkeman, Mats, additional, Laurell, Anna, additional, Räty, Riikka, additional, Elonen, Erkki, additional, Andersen, Niels S., additional, Brown, Peter de Nully, additional, and Geisler, Christian H, additional

Published
2016
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18. Center Characteristics and Procedure-Related Factors Have an Impact on Outcomes of Allogeneic Transplantation for Patients with CLL: A Retrospective Analysis from the European Society for Blood and Marrow Transplantation (EBMT)

Author

Schetelig, Johannes, primary, de Wreede, Liesbeth C, additional, Andersen, Niels S., additional, Moreno, Carol, additional, van Gelder, Michel, additional, Vitek, Antonin, additional, Karas, Michal, additional, Michallet, Mauricette, additional, Machaczka, Maciej J, additional, Gramatzki, Martin, additional, Beelen, Dietrich W., additional, Finke, Jurgen, additional, Delgado, Julio, additional, Volin, Liisa, additional, Passweg, Jakob, additional, Dreger, Peter, additional, Schaap, Nicolaas PM, additional, Theobald, Matthias, additional, Henseler, Anja, additional, van Biezen, Anja, additional, Bornhaeuser, Martin, additional, Iacobella, Simona, additional, Putter, Hein, additional, Schönland, Stefen, additional, and Kröger, Nicolaus, additional

Published
2016
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19. Chronic Graft-Versus-Host Disease in Double Cord Blood Transplantation According to National Institutes of Health 2005 Criteria: A Study on Behalf of Eurocord and Cord Blood Committee of Cellular Therapy and Immunobiology Working Party of the EBMT

Author

Hayashi, Hiromi, primary, Ruggeri, Annalisa, additional, Rafii - El Ayoubi, Hanadi, additional, Cornelissen, Jan J., additional, Socié, Gerard, additional, Andersen, Niels S., additional, Michallet, Mauricette, additional, Karakasis, Dimitrios, additional, Petersen, Eefke, additional, Veelken, Joan Hendrik, additional, Cahn, Jean Yves, additional, Rohrlich, Pierre-Simon, additional, Mercier, Melanie, additional, Volt, Fernanda, additional, Kenzey, Chantal, additional, Xavier, Erick, additional, Rocha, Vanderson, additional, and Gluckman, Eliane, additional

Published
2016
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20. 15-year follow-up of the Second Nordic Mantle Cell Lymphoma trial (MCL2): prolonged remissions without survival plateau

Author

Eskelund, Christian W., primary, Kolstad, Arne, additional, Jerkeman, Mats, additional, Räty, Riikka, additional, Laurell, Anna, additional, Eloranta, Sandra, additional, Smedby, Karin E., additional, Husby, Simon, additional, Pedersen, Lone B., additional, Andersen, Niels S., additional, Eriksson, Mikael, additional, Kimby, Eva, additional, Bentzen, Hans, additional, Kuittinen, Outi, additional, Lauritzsen, Grete F., additional, Nilsson-Ehle, Herman, additional, Ralfkiaer, Elisabeth, additional, Ehinger, Mats, additional, Sundström, Christer, additional, Delabie, Jan, additional, Karjalainen-Lindsberg, Marja-Liisa, additional, Workman, Christopher T., additional, Garde, Christian, additional, Elonen, Erkki, additional, Brown, Peter, additional, Grønbaek, Kirsten, additional, and Geisler, Christian H., additional

Published
2016
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21. Long-Term Follow-up Data Support the Curative Potential of Allogeneic Hematopoietic Cell Transplantation in Patients with Chronic Lymphocytic Leukemia: A Retrospective Analysis from the Chronic Malignancies Working Party of the EBMT

Author

Van Gelder, Michel, primary, de Wreede, Liesbeth, additional, Henseler, Anja, additional, van Biezen, Anja, additional, Niederwieser, Dietger, additional, Karas, Michal, additional, Andersen, Niels S., additional, Gramatzki, Martin, additional, Dreger, Peter, additional, Bunjes, Donald W., additional, Petersen, Eefke J, additional, Potter, Michael N, additional, Beelen, Dietrich, additional, Yakoub-Agha, Ibrahim, additional, Cornelissen, Jan J, additional, Russell, Nigel, additional, Finke, Jurgen, additional, Schoemans, Helene, additional, Blaise, Didier, additional, Shankara, Paneesha, additional, Vitek, Antonin, additional, Bornhäuser, Martin, additional, Schönland, Stefan, additional, Kröger, Nicolaus, additional, and Schetelig, Johannes, additional

Published
2014
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22. Outcomes of Cord Blood Transplantation Using Reduced Intensity Conditioning for Chronic Lymphocytic Leukemia: A Retrospective Study on Behalf of Eurocord, SFGM-TC and Cqwp-EBMT

Author

Xavier, Erick, primary, Cornillon, Jérôme, additional, Ruggeri, Annalisa, additional, Chevallier, Patrice, additional, Cornelissen, Jan J., additional, Andersen, Niels S., additional, Maillard, Natacha, additional, Nguyen-coq, Stephanie, additional, Blaise, Didier, additional, Deconinck, Eric, additional, Veelken, Hendrik, additional, Corby, Anne, additional, Huynh, Anna, additional, Gonzalez Perez, Marta Sonia, additional, Cahn, Jean-Yves, additional, Milpied, Noel, additional, Mohty, Mohamad, additional, Michallet, Mauricette, additional, Bourhis, Jean-Henri, additional, de Revel, Thierry, additional, Berthou, Christian, additional, Ceballos, Patrice, additional, Turlure, Pascal, additional, Donnini, Irene, additional, Sica, Simona, additional, Peffault de la tour, Regis, additional, Gluckman, Eliane, additional, Kroeger, Nicolaus, additional, Schetelig, Johannes, additional, and Rocha, Vanderson, additional

Published
2014
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23. Allogeneic HCT in Patients with 17p-CLL: Results of a Non-Interventional Study of the EBMT & Eric

Author

Schetelig, Johannes, primary, Hoek, Jennifer, additional, Stilgenbauer, Stephan, additional, Bornhäuser, Martin, additional, Andersen, Niels S., additional, Fox, Christopher P, additional, Lenhoff, Stig, additional, Bunjes, Donald W., additional, Volin, Liisa, additional, Shimoni, Avichai, additional, Schroyens, Wilfried A, additional, van Gelder, Michel, additional, van Biezen, Anja, additional, de Wreede, Liesbeth, additional, de Witte, Theo M, additional, Kröger, Nicolaus, additional, and Dreger, Peter, additional

Published
2014
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24. 90y-Ibritumumab Tiuxetan (Zevalin®-BEAM/C with Autologous Stem Cell Support as Therapy for Advanced Mantle Cell Lymphoma. - Preliminary Results From the Third Nordic II Study (MCL3)

Author

Kolstad, Arne, Laurell, Anna, Andersen, Niels S, Elonen, Erkki, Raty, Riikka, Pedersen, Lone Bredo, Bogsrud, Annik Trond Velde, Nordstrom, Marie, Gillström, Dorte Balle, Hansen, Per Boye, Bentzen, Hans, Fagerli, Unn-Merete, Meyer, Peter, Nilsson-Ehle, Herman, Jerkeman, Mats, Lehman, Anne Kristine, Lauritzen, Grete F, Sundstrom, Christer, Delabie, Jan, Karjaalainen-Lindsberg, Marja-Liisa, Ralfkiaer, Elisabeth, Ehinger, Mats, and Geisler, Christian H.

Abstract

The Nordic Lymphoma Group has since 1996 conducted three consecutive phase II trials for front-line treatment of MCL patients ≤ 65 years of age. The first protocol (MCL1) 1996-2000 introduced high-dose chemotherapy with autologous stem cell support (unpurged or ex vivo purged) as consolidation after 4 cycles of intensified CHOP (maxi-CHOP). The results were disappointing, as the majority of patients relapsed. 1 Being in CR pre-transplant was the most important factor for outcome. Hence, in the second trial (MCL2) 2000-2006 induction therapy was intensified by adding high-dose Ara-C and rituximab to the regimen. Compared to MCL1 this led to significant improvement of event-free and overall survival, and the rate of PCR negative stem cell grafts and bone marrow samples.2 Again, responders in less than CR pre-transplant had a significantly poorer outcome. We therefore made a further intensification for the MCL3 study (2006-2009) by adding 90Y-Ibritumomab tiuxetan (Zevalin ®) to the high-dose BEAC/BEAM to responders not in CR. Methods: As in the MCL1 and 2 studies newly diagnosed stage II-IV MCL patients ≤ 65 years were included. Induction treatment was identical to that of the MCL2 study with alternating cycles of maxi-CHOP-rituximab (3 cycles) and Ara-C-rituximab (3 cycles). Response evaluation was done after cycle 5. PET/CT was recommended, but could not influence the response evaluation, which was done according to the International Workshop criteria. Responders underwent in vivo purged harvest of stem cells after cycle 6 (Ara-C + 2 doses of rituximab). Patients in CRu or PR received a standard dose 90Y-Ibritumomab tiuxetan (0.4 mCi/kg) one week prior to the BEAM/BEAC, CR patients received BEAM/BEAC alone. Patients are followed by CT-scans, bone marrow and blood samples, including PCR for minimal residual disease or molecular relapse. For molecular relapse preemptive treatment with 4 standard doses of rituximab, as in the MCL2 study3, is given. Results: The planned accrual of 160 patients was reached in June 2009. The patient characteristics are similar to those of the MCL2 trial with a median age of 57 years (28-65), the majority male (80%) and in stage IV (89%) with bone marrow involvement (74%). The response rates pre-transplant so far compare favorably with data from MCL2 with 50% in CR, 18% in CRu, and 28% in PR. Only 4 out of 128 evaluable patients did not respond (3%) and there was one case (1%) of treatment-related mortality during induction therapy. While it is still too early to assess the impact of the 90Y-Ibritumomab tiuxetan on the progression-free survival, the side effects were similar to those of the MCL2 study including a treatment related mortality of 4%. Fifty-five patients in CRu or PR have so far been treated with 90Y-Ibritumomab tiuxetan, with no indication of any added toxicity. Only 12 out of 133 patients (10%) have not undergone transplant, 5 due to stem cell harvest failure, 3 due to toxicity and 4 due to non response to induction treatment. PET-scan prior to transplant was positive in 2% of CR patients, 20% of CRu patients and 54% of PR patients. Patients with a positive PET-scan pre-transplant had a 36% chance of achieving a molecular remission post-transplant, compared to 92% of cases with a negative PET-scan (pConclusion: The high response rates after induction treatment achieved in the MCL2 study are confirmed in the present study. Adding 90Y-Ibritumomab tiuxetan to high-dose chemotherapy for responding patients not in CR prior to transplant is feasible and does not increase toxicity. A negative PET-scan prior to transplant predicts for a molecular remission after the transplant.References:1. Andersen et al, Eur J Cancer, 2002, 38: 401-4082. Geisler et al, Blood, 2008, 112: 2687-26933. Andersen et al J Clin Oncol 2009 epub ahead of press

Published
2009

25. 90y-Ibritumumab Tiuxetan (Zevalin ®)-BEAM/C with Autologous Stem Cell Support as Frontline Therapy for Advanced Mantle Cell Lymphoma. – Preliminary Results From the Third Nordic MCL Phase II Study (MCL3).

Author

Kolstad, Arne, primary, Laurell, Anna, additional, Andersen, Niels S, additional, Elonen, Erkki, additional, Raty, Riikka, additional, Pedersen, Lone Bredo, additional, Loft, Annika, additional, Bogsrud, Trond Velde, additional, Nordstrom, Marie, additional, Gillstrom, Dorte, additional, Hansen, Per Boye, additional, Bentzen, Hans, additional, Fagerli, Unn-Merete, additional, Meyer, Peter, additional, Nilsson-Ehle, Herman, additional, Jerkeman, Mats, additional, Lehmann, Anne Kristine, additional, Lauritzsen, Grete F, additional, Sundstrom, Christer, additional, Delabie, Jan, additional, Karjalainen-Lindsberg, Marja-Liisa, additional, Ralfkiaer, Elisabeth, additional, Ehinger, Mats, additional, and Geisler, Christian H., additional

Published
2009
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26. Pre-Emptive Treatment With Rituximab of Molecular Relapse After Autologous Stem Cell Transplantation in Mantle Cell Lymphoma

Author

Andersen, Niels S., primary, Pedersen, Lone B., additional, Laurell, Anna, additional, Elonen, Erkki, additional, Kolstad, Arne, additional, Boesen, Anne Marie, additional, Pedersen, Lars M., additional, Lauritzsen, Grete F., additional, Ekanger, Roald, additional, Nilsson-Ehle, Herman, additional, Nordström, Marie, additional, Fredén, Susanne, additional, Jerkeman, Mats, additional, Eriksson, Mikael, additional, Väärt, Jaan, additional, Malmer, Beatrice, additional, and Geisler, Christian H., additional

Published
2009
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28. Nordic Mantle Cell Lymphoma (MCL) Project: Prolonged Follow-Up of 86 Patients Treated with BEAM/BEAC + PBSCT Confirms That Addition of High-Dose Ara-C and Rituximab to CHOP Induction + In-Vivo Purging with Rituximab Increases Clinical and Molecular Response Rates, PCR-Neg. Grafts, Failure-Free, Relapse-Free and Overall Survival.

Author

Geisler, Christian H., primary, Elonen, Erkki, additional, Kolstad, Arne, additional, Laurell, Anna, additional, Andersen, Niels S., additional, Pedersen, Lone B., additional, Jerkeman, Mats, additional, Nordstroem, Marie, additional, Lauritzen, Grete F., additional, Ralfkiaer, Elisabeth, additional, Aakerman, Maans, additional, Sundstroem, Christer, additional, Langholm, Ruth, additional, and Karjalainen-Lindsberg, Marja-Liisa, additional

Published
2004
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32. Error in a study of the outcome of mantle cell lymphoma: Nordic MCL2 Trial Update: 6-year follow-up after intensive immunochemotherapy for untreated mantle cell lymphoma followed by BEAM or BEAC + autologous stem-cell support: still very long survival but late relapses do occur

Author

Geisler, Christian H., Kolstad, Arne, Laurell, Anna, Jerkeman, Mats, Räty, Riikka, Andersen, Niels S., Pedersen, Lone B., Eriksson, Mikael, Nordström, Marie, Kimby, Eva, Bentzen, Hans, Kuittinen, Outi, Lauritzsen, Grete F., Nilsson-Ehle, Herman, Ralfkiær, Elisabeth, Ehinger, Mats, Sundström, Christer, Delabie, Jan, Karjalainen-Lindsberg, Marja-Liisa, and Brown, Peter

Subjects
PUBLISHED errata, LYMPHOMAS
Abstract

A correction to the article "Nordic MCL2 Trial Update: 6-year follow-up after intensive immunochemotherapy for untreated mantle cell lymphoma followed by BEAM or BEAC + autologous stem-cell support: Still very long survival but late relapses do occur" published in previous issue is presented.

Published
2012
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33. Nordic Mantle Cell Lymphoma (MCL) Project: Preemptive Rituximab Treatment of Molecular Relapse Following Autotransplant Can Reinduce Molecular Remission and Prolonged Disease-Free Survival.

Author

Geisler, Christian H., Elonen, Erkki, Kolstad, Arne, Laurell, Anna, Pedersen, Lone B., Andersen, Niels S., Jerkeman, Mats, Nordstrom, Marie, Lauritzen, Grethe F., Ralfkiaer, Elisabeth, Akerman, Maans, Sundstrom, Christer, Langholm, Ruth, Karjalainen-Lindsberg, Marja-Liisa, Kuittinen, Outti, and Eriksson, Mikael

Abstract

The 2nd. Nordic Lymphoma Group mantle cell lymphoma (MCL2) protocol has demonstrated the importance of Ara-C and Rituximab in the induction chemotherapy and stem-cell mobilisation before high-dose therapy and autologous stem-cell transplant (1). By July 2005, 128 patients (83% stage IV) had completed protocol treatment consisting of 3 series of R-CHOP and 3 series of R-Ara-C, stem-cell harvest and high-dose therapy with BEAM/BEAC with ASCT. The 5-year failure-free and overall survival is 50% and 83% respectively, significantly higher than the historic control group of the Nordic MCL1 protocol with the same treatment without HD-Ara-C and Rituximab (P<0.0001). Patients with a molecular marker (t(11;14) or clonal IgH rearrangement) identified at the time of diagnosis in bone marrow and blood, undergo regular molecular follow-up posttransplant,. Patients who turn PCR-positive or increase their qPCR signal, without clinical disease, are offered preemptive treatment with Rituximab 375 mg/m2 Wx4. Of 75 patients with molecular markers who had completed treatment, 55 remain PCR-negative and 20 have become/remained PCR-pos. posttransplant. Clinical relapse ocurred significantly more often in the latter group (11 of 20) than in the PCR-neg. patients (4 of 55) (P<0.0001) (Fig.1). Ten of the 20 PCR-positive patient did not receive preemptive rituximab: five due to immediate clinical relapse, 2 due to stable qPCR signals, one due to protocol error and two await treatment. Of 10 patients who did receive preemptive rituximab 8 again became PCR-negative and 2 remain PCR-positive. Six of the 10 Rituximab treated patients remain in clinical and molecular remission 200–600 days after the Rituximab treatment (Fig. 2). Conclusions: In MCL, molecular relapse is a harbinger of imminent clinical relapse, whereas continuous molecular remission is associated with prolonged disease-free survival (89% at 4 years) Rituximab preemptive treatment can reinduce molecular remission and may delay clinical relapse. Following molecular relapse, only Rituximab treated patients (6 of 8 evaluable) remain disease-free. FIG. 1. NORDIC NCL-2 PROTOCOL: RELAPSE-FREE SURVIVAL ACC. TO MOLECULAR STATUS POSTTRANSPALNT FIG. 1. NORDIC NCL-2 PROTOCOL: RELAPSE-FREE SURVIVAL ACC. TO MOLECULAR STATUS POSTTRANSPALNT FIG. 2. NORDIC NCL-2 PROTOCOL: RELAPSE-FREE SURVIVAL FROM TIME OF MOLECULAR RELAPSE. FIG. 2. NORDIC NCL-2 PROTOCOL: RELAPSE-FREE SURVIVAL FROM TIME OF MOLECULAR RELAPSE.

Published
2005
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34. Trends in survival and cure after allogeneic haematopoietic cell transplantation for acute myeloid leukaemia from 2000 to 2020: A Danish population-based cohort study.

Author

Gjaerde LK, Jakobsen LH, Juhl-Christensen C, Olesen G, Petruskevicius I, Severinsen MT, Marcher CW, Theilgaard-Mönch K, Andersen NS, Friis LS, Kornblit B, Petersen SL, Schjødt I, and Sengeløv H

Subjects
Humans, Cohort Studies, Neoplasm Recurrence, Local, Denmark epidemiology, Transplantation Conditioning, Hematopoietic Stem Cell Transplantation, Leukemia, Myeloid, Acute therapy, Graft vs Host Disease
Published
2023
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35. Centre characteristics and procedure-related factors have an impact on outcomes of allogeneic transplantation for patients with CLL: a retrospective analysis from the European Society for Blood and Marrow Transplantation (EBMT).

Author

Schetelig J, de Wreede LC, Andersen NS, Moreno C, van Gelder M, Vitek A, Karas M, Michallet M, Machaczka M, Gramatzki M, Beelen D, Finke J, Delgado J, Volin L, Passweg J, Dreger P, Schaap N, Wagner E, Henseler A, van Biezen A, Bornhäuser M, Iacobelli S, Putter H, Schönland SO, and Kröger N

Subjects
Adult, Aged, Delivery of Health Care statistics & numerical data, Europe epidemiology, Female, Humans, Kaplan-Meier Estimate, Karnofsky Performance Status, Leukemia, Lymphocytic, Chronic, B-Cell mortality, Male, Middle Aged, Recurrence, Registries, Retrospective Studies, Risk Factors, Transplantation Conditioning methods, Hematopoietic Stem Cell Transplantation methods, Leukemia, Lymphocytic, Chronic, B-Cell therapy, Professional Practice statistics & numerical data
Abstract

The best approach for allogeneic haematopoietic stem cell transplantations (alloHCT) in patients with chronic lymphocytic leukaemia (CLL) is unknown. We therefore analysed the impact of procedure- and centre-related factors on 5-year event-free survival (EFS) in a large retrospective study. Data of 684 CLL patients who received a first alloHCT between 2000 and 2011 were analysed by multivariable Cox proportional hazards models with a frailty component to investigate unexplained centre heterogeneity. Five-year EFS of the whole cohort was 37% (95% confidence interval [CI], 34-42%). Larger numbers of CLL alloHCTs (hazard ratio [HR] 0·96, P = 0·002), certification of quality management (HR 0·7, P = 0·045) and a higher gross national income per capita (HR 0·4, P = 0·04) improved EFS. In vivo T-cell depletion (TCD) with alemtuzumab compared to no TCD (HR 1·5, P = 0·03), and a female donor compared to a male donor for a male patient (HR 1·4, P = 0·02) had a negative impact on EFS, but not non-myeloablative versus more intensive conditioning. After correcting for patient-, procedure- and centre-characteristics, significant variation in centre outcomes persisted. In conclusion, further research on the impact of centre and procedural characteristics is warranted. Non-myeloablative conditioning appears to be the preferable approach for patients with CLL., (© 2017 John Wiley & Sons Ltd.)

Published
2017
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