Status:
COMPLETED
Allogeneic Hematopoietic Stem Cell Transplantation After Reduced-intensity Conditioning for Relapsed Follicular Lymphoma
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Lymphoma, Follicular
Stem Cell Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 lymp...
Detailed Description
Follicular lymphomas are chemosensitive neoplasms characterized by a relentless succession of remissions and relapses when treated with conventional chemotherapy. The successive periods of remission a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 3 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01208896
Start Date
February 3 2011
End Date
September 28 2017
Last Update
August 9 2018
Active Locations (26)
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1
University Hospital Angers
Angers, Angers, France, 49033
2
Service Hématologie, Hôpital Minjoz
Besançon, France, 25030
3
Service Hématologie, Hôpital Augustin Morvan
Brest, France, 29609
4
University Hospital, Caen
Caen, France