Allogeneic Hematopoietic Stem Cell Transplantation After Reduced-intensity Conditioning for Relapsed Follicular Lymphoma

• Status: Completed
• Trial end date: 2017-09-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborator: Roche Pharma AG

Criteria

Inclusion Criteria:

• Age ≥ 18 and ≤ 65 years

• Follicular lymphoma confirmed by a biopsy at the last relapse.

• 2nd, 3rd or 4th complete or partial response according to Cheson's criteria 1 (Annexe 1)

• Relapse after autologous-SCT except if the absence of autologous SCT is due to a failure of collecting peripheral stem cells or investigator decision to not proceed to the autologous graft because of serious criteria

• Relapse after at least one line of treatment with rituximab

• Karnofsky index > 70%

• HLA Matched related or unrelated donor (10/10 matching; HLA-A, HLA-B, HLA-C, HLA-DRB1, HLA-DQB1)

• Signed informed consent

Exclusion Criteria:

• Stable or progressive disease according to Cheson's criteria1 (Annexe 1)

• Absence of treatment with rituximab before the last relapse

• Cardiac insufficiency (ejection fraction < 50% by echocardiography)

• Pulmonary disease characterized by DLCO < 60%

• Renal insufficiency (clearance of creatinin < 60 ml/min)

• Hepatic disease characterized by ASAT and/or ALAT and/or total bilirubin > 2 times the upper normal value except in case of Gilbert's disease or hepatic lymphoma

• HIV positive test

• Bacterial, Viral or Fungal uncontrolled infections

• Pregnant or breast feeding woman

• Cancer in the last 5 years except in case of cutaneous baso-cellular cancer or epithelioma "in situ" of the uterine cervix