Rituximab Purging and/or Maintenance in Patients Undergoing Autologous Transplantation for Relapsed Follicular Lymphoma: A Prospective Randomized Trial From the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation

Pettengell, Ruth; Schmitz, Norbert; Gisselbrecht, Christian; Smith, Graeme; Patton, W. N.; Metzner, Bernd; Caballero, Dolores; Tilly, Hervé; Walewski, Jan; Bence‐Bruckler, Isabelle; To, Bik; Geisler, Christian H.; Schots, Rik; Kimby, Eva; Taverna, Christian; Kozák, Tomáš; Dreger, Peter; Uddin, Ruzena; Elvira, Carmen Ruiz de; Goldstone, Anthony H.

doi:10.1200/jco.2012.47.1862

Cited by 109 publications

(64 citation statements)

References 29 publications

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“…39,40,44 The median age of 48 years in prospective trials such as the CUP trial is similar to that in the EBMT LYM1 trial with a mean age of 51.6 years. 16,49 More recent registry studies report a median age between 49 and 57 years. 39,40,44,53 Patients undergoing ASCT continue to be younger patients despite reasonable NRM in the transplanted population.…”

Section: Outcomes Of Asct For Inhlmentioning

confidence: 99%

“…Toxicity in the ASCT population is well managed in the modern era, with NRM ranging from 3% to 5%. 44,49,53 A summary of the efficacy outcomes of key ASCT studies is provided in Table 2.…”

Section: Outcomes Of Asct For Inhlmentioning

confidence: 99%

“…16 The European Society for Blood and Marrow Transplantation (EBMT) LYM1 trial used the BEAM regimen. 49 The question of TBI in FL ASCT procedures was recently evaluated in an EBMT study comparing outcomes of TBI-containing regimens with BEAM. 50 Both NRM (6% at 5 years and 10% at 10 years) and secondary malignancies (9.7% after TBI and 7.9% after BEAM; P 5 .19) were similar.…”

Section: Outcomes Of Asct For Inhlmentioning

confidence: 99%

“…16 Similarly, the other randomized trial in the relapsed population (EBMT LYM1) is of limited value because this trial in second or third remission mandated that patients be rituximab naïve. 49 The trial used a factorial design and randomly assigned patients to in vivo purging with rituximab or observation before ASCT or to rituximab maintenance with 1 dose For personal use only. on May 11, 2018. by guest www.bloodjournal.org From given every 2 months for 4 doses or observation in the post-ASCT setting.…”

Section: Outcomes Of Asct For Inhlmentioning

confidence: 99%

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The role of autologous and allogeneic stem cell transplantation in the management of indolent B-cell lymphoma

Kuruvilla

2016

Blood

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Despite improvements over the past decade in the overall survival of patients with indolent non-Hodgkin lymphomas, these lymphomas remain largely incurable with standard therapies. Immunochemotherapy with rituximab-based regimens has become a well-established standard of care in the primary and relapsed disease settings. The role of hematopoietic stem cell transplantation in indolent lymphoma has been defined by the adoption of this therapy largely in the relapse setting because randomized trials in the first-line setting have not shown survival advantages. Allogeneic stem cell transplantation has the possibility for cure because of the potential for immunologic graft-versus-lymphoma effect, but there are significant concerns regarding nonrelapse mortality. Autologous stem cell transplantation offers a safe treatment platform, but relapse remains a significant issue. The role of transplantation in the current treatment landscape of immunochemotherapy has not been conclusively proven, and randomized trials are lacking. This review summarizes the current relevant data regarding transplantation in indolent non-Hodgkin lymphoma and highlights the issues relevant to clinicians in the field.

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Section: Outcomes Of Asct For Inhlmentioning

confidence: 99%

“…Toxicity in the ASCT population is well managed in the modern era, with NRM ranging from 3% to 5%. 44,49,53 A summary of the efficacy outcomes of key ASCT studies is provided in Table 2.…”

Section: Outcomes Of Asct For Inhlmentioning

confidence: 99%

Section: Outcomes Of Asct For Inhlmentioning

confidence: 99%

Section: Outcomes Of Asct For Inhlmentioning

confidence: 99%

See 2 more Smart Citations

The role of autologous and allogeneic stem cell transplantation in the management of indolent B-cell lymphoma

Kuruvilla

2016

Blood

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“…In a large randomized trial, patients with relapsed FL who achieved response with salvage chemotherapy were randomly assigned using a factorial design to rituximab purging and rituximab maintenance. A 10-year PFS was 48% for the purging cohort and 42% for the non-purging group while maintenance had a significant effect on PFS [16]. However, in this study efficacy of in vivo purging has not assessed by molecular evaluation of harvest.…”

Section: Discussionmentioning

confidence: 89%

Autologous stem cell transplantation with in vivo purged progenitor cells shows long‐term efficacy in relapsed/refractory follicular lymphoma

et al. 2015

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High-dose chemotherapy with autologous stem cell transplantation (ASCT) has been shown effective in the control of relapsed/refractory follicular lymphoma. We evaluate the long-term outcome of patients with relapsed or refractory follicular lymphoma treated with ASCT with in vivo purged progenitors cells. We report the long-term results of a prospective multicenter phase 2 trial on 124 relapsed/refractory follicular lymphoma patients treated with a program of anthracycline-based debulking chemotherapy, immunochemotherapy, mobilization of in vivo purged PBSC followed by ASCT. Median age was 52 years; 14% of patients had grade 3A histology. Debulking chemotherapy produced CR in 16% and PR in 71%, while 13% of patients progressed. After rituximab, cyclophosphamide, vincristine, prednisone (R-COP), CR was obtained in 60% and PR in 35%; 118 patients successfully mobilized PBSC and 117 proceeded to ASCT. The harvest in all the 32 molecularly informative patients was bcl-2 negative. TRM was 0%. The 5-year PFS was 54% and the 5-year OS was 83%. After a median f-up of 6.7 years (range 1.5-13.6), 54% are still in CR. These data show that prolonged PFS is achievable in relapsed/refractory patients with high dose autologous transplantation of in vivo purged progenitor cells.

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Maintenance Therapies for Hodgkin and Non-Hodgkin Lymphomas After Autologous Transplantation

et al. 2019

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IMPORTANCE Maintenance therapies are often considered as a therapeutic strategy in patients with lymphoma following autologous hematopoietic cell transplantation (auto-HCT) to mitigate the risk of disease relapse. With an evolving therapeutic landscape, where novel drugs are moving earlier in therapy lines, evidence relevant to contemporary practice is increasingly limited. The American Society for Blood and Marrow Transplantation (ASBMT), Center for International Blood and Marrow Transplant Research (CIBMTR), and European Society for Blood and Marrow Transplantation (EBMT) jointly convened an expert panel with diverse expertise and geographical representation to formulate consensus recommendations regarding the use of maintenance and/or consolidation therapies after auto-HCT in patients with lymphoma. OBSERVATIONS The RAND-modified Delphi method was used to generate consensus statements where at least 75% vote in favor of a recommendation was considered as consensus. The process included 3 online surveys moderated by an independent methodological expert to ensure anonymity and an in-person meeting. The panel recommended restricting the histologic categories covered in this project to Hodgkin lymphoma (HL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma. On completion of the voting process, the panel generated 22 consensus statements regarding post auto-HCT maintenance and/or consolidation therapies. The grade A recommendations included endorsement of: (1) brentuximab vedotin (BV) maintenance and/or consolidation in BV-naïve high-risk HL, (2) rituximab maintenance in MCL undergoing auto-HCT after first-line therapy, (3) rituximab maintenance in rituximab-naïve FL, and (4) No post auto-HCT maintenance was recommended in DLBCL. The panel also developed consensus statements for important real-world clinical scenarios, where randomized data are lacking to guide clinical practice. CONCLUSIONS AND RELEVANCE In the absence of contemporary evidence-based data, the panel found RAND-modified Delphi methodology effective in providing a rigorous framework for developing consensus recommendations for post auto-HCT maintenance and/or consolidation therapies in lymphoma.

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Rituximab Purging and/or Maintenance in Patients Undergoing Autologous Transplantation for Relapsed Follicular Lymphoma: A Prospective Randomized Trial From the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation

Abstract: Rituximab maintenance after HDC-ASCT is safe and significantly prolongs PFS but not OS in patients undergoing transplantation for relapsed FL. Pretransplantation rituximab in vivo purging, even in rituximab-naive patients, failed to improve PFS or OS.

Cited by 109 publications

References 29 publications

The role of autologous and allogeneic stem cell transplantation in the management of indolent B-cell lymphoma

The role of autologous and allogeneic stem cell transplantation in the management of indolent B-cell lymphoma

Autologous stem cell transplantation with in vivo purged progenitor cells shows long‐term efficacy in relapsed/refractory follicular lymphoma

Maintenance Therapies for Hodgkin and Non-Hodgkin Lymphomas After Autologous Transplantation

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