Status:
COMPLETED
Amplifying Graft-Versus-Tumor Effect by Donor Regulatory T-Cell Depletion Before Donor Lymphocytes Infusion
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Université Paris XII
Pierre and Marie Curie University
Conditions:
Hematologic Neoplasms
Relapse
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The investigators have previously shown that depletion of CD4+CD25+FoxP3+ regulatory T cells (Treg) enhances the alloreactivity of T lymphocytes, as attested by an accelerated GVHD after allogeneic he...
Detailed Description
We have previously shown that depletion of CD4+CD25+FoxP3+ regulatory T cells (Treg) enhances the alloreactivity of T lymphocytes, as attested by an accelerated GVHD after allogeneic hematopoietic ste...
Eligibility Criteria
Inclusion
- Hematological malignancy except chronic myeloid leukaemia.
- Previous allogeneic hematopoietic stem cell transplantation.
- Relapse diagnosed at the molecular, cytogenetic, or cytological level.
- Failure of a previous stdILD or inclusion in first intention if progressive disease.
- Age \> 18 years and \< 70 years at the time of inclusion.
- Performance status considered on the score ECOG \< 2.
- Life expectation 1-month-old superior.
- Signed written informed consent.
- Negative HCG in the 7 days preceding the inclusion for women in age of procreation.
- Membership of the French national insurance.
Exclusion
- Chronic myeloid leukemia
- Grade \>II acute GVHD or chronic extensive GVHD at the time of inclusion.
- Patient receiving an immunosuppressive treatment for GVHD treatment at the time of inclusion.
- Dysfunction of liver (ALAT/ASAT \> 5 N, or bilirubin \> 50 µM), or of the renal function (creatinine clearance \< 30 ml / min).
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00987987
Start Date
December 1 2005
End Date
December 1 2009
Last Update
January 24 2011
Active Locations (1)
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1
Hopital Henri Mondor
Créteil, France, 94000