Status:
TERMINATED
T-cell and B-cell Depletion in Allogeneic Peripheral Blood Stem Cell Transplantation
Lead Sponsor:
Radboud University Medical Center
Conditions:
Leukemia, Myeloid
Leukemia, Lymphocytic
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
T-cell and B-cell depletion in allogeneic peripheral blood stem cell transplantation by using immunomagnetic negative and positive selection procedures Background: Removal of T-cells from the donor ...
Eligibility Criteria
Inclusion
- Patients with the diagnosis of:
- De novo acute myeloid leukaemia in first or second remission.
- Secondary acute myeloid leukaemia in first or second remission supervening after myelodysplastic syndrome or cytotoxic / immunosuppressive therapy.
- Acute lymphoblastic leukaemia in first or second remission.
- Myelodysplastic syndrome.
- Chronic myeloid leukaemia, patients who are candidate for SCT.
- Malignant lymphoma following relapse or first line therapy resistant.
- Aggressive mantle cell lymphoma in first complete remission.
- Age 18-65 years.
- WHO performance 0-1 (see appendix ).
- Availability of an HLA-identical sibling or HLA, A, B, DRB, DQB -identical VUD donor.
- Life expectancy \> 3 months.
- Witnessed written informed consent.
Exclusion
- Patients with severe cardiac dysfunction (NYHA-classification II-IV)
- Patients with severe pulmonary dysfunction (vital capacity or diffusion \< 70% of predicted value).
- Patients with hepatic dysfunction, bilirubin or transaminases \> 2.5 x upper normal limit
- Patients with renal dysfunction, serum creatinin \> 150 umol/liter or clearance \< 40 ml/minute.
- Patients with a history of moderate ore severe CNS disturbances and psychiatric problems.
- Prior treatment with chemotherapy, immunotherapy, radiation therapy or surgery within the last 3 weeks before entering the study.
- Patients with active uncontrolled infections.
- Patients who are poor medical risks because of non malignant systemic disease.
- Patients with severe coagulopathy.
- Patients to be known HIV positive.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00306332
Start Date
March 1 2006
Last Update
August 18 2009
Active Locations (1)
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1
476 Hematology, University Medical Centre St Radboud Nijmegen
Nijmegen, Netherlands, 6500 HB