Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial

Glaß, Bertram; Hasenkamp, Justin; Wulf, Gerald; Dreger, Peter; Pfreundschuh, Michael; Gramatzki, Martin; Silling, Gerda; Wilhelm, Christian; Zeis, Matthias; Görlitz, Anke; Pfeiffer, Sebastian; Hilgers, Reinhard; Truemper, Lorenz; Schmitz, Norbert

doi:10.1016/s1470-2045(14)70161-5

Cited by 105 publications

(72 citation statements)

References 38 publications

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“…[11][12][13] Overall, allogeneic SCT in DLBCL has been shown to be associated with durable disease control and graft-versus-lymphoma effect, as demonstrated by the role of immunotherapeutic intervention post allo-SCT. [14][15][16] Although prior ASCT may adversely affect PFS, encouraging OS has been reported for allogeneic SCT as second transplant procedure in DLBCL after various conditioning regimens with various donor types. 12,[17][18][19] Recently, the CIBMTR reviewed 503 patients with allogeneic SCT (25% myeloablative conditioning) after experiencing disease progression or relapse following prior ASCT.…”

Section: Discussionmentioning

confidence: 99%

Outcomes of diffuse large B-cell lymphoma patients relapsing after autologous stem cell transplantation: an analysis of patients included in the CORAL study

Neste

Schmitz

Mounier

et al. 2016

Bone Marrow Transplant

108

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In the CORAL study, 255 chemosensitive relapses with diffuse large B-cell lymphoma (DLBCL) were consolidated with autologous stem cell transplantation (ASCT), and 75 of them relapsed thereafter. The median time between ASCT and progression was 7.1 months. The median age was 56.1 years; tertiary International Prognosis Index (tIPI) observed at relapse was 0-2 in 71.6% of the patients and 42 in 28.4%. The overall response rate to third-line chemotherapy was 44%. The median overall survival (OS) was 10.0 months (median follow-up: 32.8 months). Thirteen patients received an allogeneic SCT, and three a second ASCT. The median OS was shorter among patients who relapsed o6 months (5.7 months) compared with those relapsing ⩾ 12 months after ASCT (12.6 months, P = 0.0221). The median OS in patients achieving CR, PR or no response after the third-line regimen was 37.7 (Po0.0001), 10.0 (P = 0.03) and 6.3 months, respectively. The median OS varied according to tIPI: 0-2: 12.6 months and 42: 5.3 months (P = 0.0007). In multivariate analysis, tIPI 42, achievement of response and remission lasting o6 months predicted the OS. This report identifies the prognostic factors for DLBCL relapsing after ASCT and thus helps to select patients for experimental therapy. INTRODUCTIONSalvage second-line chemotherapy followed by high-dose therapy and autologous stem cell transplantation (ASCT) is the standard of care for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In the CORAL study, two salvage regimens (R-DHAP (rituximab, dexamethasone, cytarabine, cisplatinum) or R-ICE (rituximab, ifosfamide, carboplatinum, etoposide)) were compared in 477 patients, and no difference was found. Only 50% of the patients could proceed to per protocol ASCT, afterwards they were randomly assigned to rituximab or observation. The 4-year event-free survival post ASCT was 52% and 53% for the rituximab and observation groups, respectively (P = 0.7). International Prognosis Index (IPI) at relapse, that is, secondary IPI (sIPI), independently predicted event-free survival, PFS and OS. Patients with DLBCL relapsing o 12 months after rituximab-containing first-line therapy were also identified as a subgroup with dismal outcome.

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Section: Discussionmentioning

confidence: 99%

Outcomes of diffuse large B-cell lymphoma patients relapsing after autologous stem cell transplantation: an analysis of patients included in the CORAL study

Neste

Schmitz

Mounier

et al. 2016

Bone Marrow Transplant

108

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“…GVHD are still unclear (14)(15)(16). The major experience derived from the pivotal studies of Khouri (14) that showed a 40 rather good disease control with the unexpected finding of a limited incidence of acute and chronic extensive GVHD.…”

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confidence: 99%

Allogeneic Stem Cell Transplantation for Relapsed/Refractory B Cell Lymphomas: Results of a Multicenter Phase II Prospective Trial including Rituximab in the Reduced-Intensity Conditioning Regimen

Dodero

Milone

Sarina

et al. 2017

Biology of Blood and Marrow Transplantation

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The graft versus host disease free, relapse free survival is 34% after transplantation in 2 lymphomas; 3Reduced extensive chronic GVHD with a combination of ATG and Rituximab in recipients of 4 unrelated graft 5One Rituximab Infusion prevents EBV-related lymphoproliferative disorders 6 Abstract 7The treatment of patients with refractory/relapsed B-Cell non-Hodgkin lymphoma (NHL) is evolving due to the 8 availability of novel drugs. Allogeneic stem cell transplantation (alloSCT) can be curative, but its morbidity and 9 mortality remain a matter of concern. We conducted a multicentre prospective phase II trial to evaluate the benefit of 10 including only one dose of Rituximab (R) in the conditioning regimen before alloSCT. The primary end-point was 11 progression-free survival. The study enrolled 121 patients with relapsed/refractory B-cell lymphomas. The conditioning 12 regimen consisted of thiotepa, cyclophosphamide, fludarabine and R (500 mg/ms). Rabbit anti-thymocyte globulin 13(ATG) was administered only in case of unrelated donors. Sixty-seven (55%) and fifty-four (45%) patients received 14 grafts from related and unrelated donors, respectively. The crude cumulative incidence (CCI) of non-relapse mortality 15(NRM) was 21% at 3-years. The CCI of chronic GVHD at 3-years was 54% and 31% in recipients of matched sibling 16 and unrelated grafts, respectively. At a median follow-up of 41 months, the estimated 3-years progression-free and 17 overall survival were 50% and 61%, respectively. Long-term outcome was also evaluated with the composite end-point 18 of graft-versus-host disease-free and relapse-free survival (GRFS). This is the first work evaluating the GRFS in a 19 prospective trial of lymphomas patients: the 1 and 3-years GRFS were 40% and 34%, respectively. AlloSCT can cure a 20 fraction of patients with rather low NRM and an encouraging PFS and GRFS.

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“…Die besonders schlechte Prognose von frühzeitigen Rezidiven (1 Jahr) und refraktären Patienten kann zur Erwägung einer allogenen Stammzelltransplantation führen [21].…”

Section: Introductionunclassified

Lymphome bei rheumatischen Erkrankungen

2017

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Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial

Cited by 105 publications

References 38 publications

Outcomes of diffuse large B-cell lymphoma patients relapsing after autologous stem cell transplantation: an analysis of patients included in the CORAL study

Outcomes of diffuse large B-cell lymphoma patients relapsing after autologous stem cell transplantation: an analysis of patients included in the CORAL study

Allogeneic Stem Cell Transplantation for Relapsed/Refractory B Cell Lymphomas: Results of a Multicenter Phase II Prospective Trial including Rituximab in the Reduced-Intensity Conditioning Regimen

Lymphome bei rheumatischen Erkrankungen

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