A Phase 2 interventional study of Reduced_intensity conditioning in Lymphoma, Follicular and Stem Cell Transplantation, sponsored by University Hospital, Bordeaux. Completed at 26 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by University Hospital, Bordeaux · Phase 2, Interventional, and Treatment
This trial will evaluate the efficacy and the safety of a strategy of allogeneic stem cell transplantation including Rituximab in the conditioning regimen for the treatment of relapsed follicular lymphoma. The rationale for using Rituximab relies on a better control of the disease and a better prophylaxis of the graft versus host disease.
Follicular lymphomas are chemosensitive neoplasms characterized by a relentless succession of remissions and relapses when treated with conventional chemotherapy. The successive periods of remission are of shorter duration and patients invariably die of their disease. At first line, patients are treated with conventional chemotherapy. At first relapse, intensive chemotherapy with autologous stem cell transplantation (SCT) is often proposed.
Allogeneic hematopoietic stem cell transplantation after reduced-intensity conditioning (RIC-allo) is an option for patients relapsing after autologous SCT, allowing long-term progression free survival of 50 to 60%. The toxic mortality related to severe acute graft versus host disease (GVHD) remains a critical issue. The goal of our study is to test in a multicentric approach a strategy of RIC-allo including rituximab in order to reduce the incidence of acute GVHD.
Around half of patients with relapsed or refractory follicular lymphomas treated with allogeneic SCT achieve long-term progression free survival whatever the conditioning regimen. Because the median age of patients with follicular lymphoma is 55 years, a reduced intensity conditioning is the most appropriate option in this setting. The outcome of patients with a chemoresistant disease is usually poor because of a high toxic mortality. As a consequence, only patients with a chemosensitive disease will be included in this study. To further reduce the toxic mortality, it is critical to reduce the incidence of severe acute GVHD. A low incidence of acute GVHD could be obtained by the use of Rituximab before and after the transplantation as reported by the MD Anderson's experience in several hematological malignancies including follicular lymphoma. Their results are impressive in patients with follicular lymphoma with long-term survival of 85%. The favored hypothesis is a depletion of patient and donor B cells reducing the presentation of minor histocompatibility alloantigens. The benefit of Rituximab could also be explained by its anti-lymphoma effects that could compensate the putative reduction of a graft versus lymphoma effect due to a better control of GVHD.
The primary objective is to estimate 2-year overall survival in this setting.
931 studies on the registry are indexed under Lymphoma, Follicular; 237 are open to participants now.
This study's enrollment of 32 is below the median of 48 across 797 interventional studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
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Exclusion Criteria:
Drug: Reduced_intensity conditioning
The conditioning regimen is composed of Fludarabine (30 mg/m2) and Cyclophosphamide (750 mg/m2), both administered intravenously at Days -5, -4, -3 with Day 0 being the day of transplantation. Rituximab will be administered intravenously at 375 mg/m2 at Day -13 and 1000 mg/m2 at Days -6, +1, +8. Tacrolimus and low-doses of methotrexate will be used for prophylaxis of GVHD.
Overall survival
Time frame: 2 year
Toxic mortality
Time frame: 2 year
Progression free survival
Time frame: 2 year
Incidence of relapse
Time frame: 2 year
Grade II-IV acute GVHD incidence
Time frame: 2 year
Chronic GVHD incidence
Time frame: 2 year
Morbidity and adverse event
Time frame: 2 year
Hematologic reconstitution, Immunologic reconstitution, Chimerism
Time frame: 2 years
Plan to share: No
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux