Prophylaxis of relapse with high dose cyclophosphamide or donor lymphocyte infusion (DLI) after haploidentical stem cell transplantation in high risk acute leukemia
Phase 2
- Conditions
- Condition 1: Acute myelblastic leukaemia. Condition 2: Acute lymphoblastic leukaemia [ALL].Acute myelblastic leukaemiaAcute lymphoblastic leukaemia [ALL]
- Registration Number
- IRCT201208041030N11
- Lead Sponsor
- Hematology-Oncology & SCT Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Diagnosis of ALL or AML; Status of first complete remission (CR1) in high risk patients and second complete remission (CR2) for others; Age: 17-50; Karnofsky score 70-100; Life expectancy: 12 months; No Full matched donor (Related, Unrelated and Cord Blood); No candidate for autologous transplantation; Live enzyme < 2 upper normal limit (UNL) and Billirubin < 1.5 UNL; Cr < 1.4; Eject fraction (EF) > 45% and Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) greater than 45%; Human Immunodeficiency Virus (HIV) negative; No addiction. Exclusion criteria: Pregnancy; Breast feeding.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse rate after transplantation. Timepoint: One year after transplantation. Method of measurement: Bone marrow examination.
- Secondary Outcome Measures
Name Time Method One year overall survival. Timepoint: One year after transplantation. Method of measurement: Examination and following treatment.;One year disease free survival. Timepoint: One year after transplantation. Method of measurement: Examination and following treatment.;Rate of chronic GVHD. Timepoint: One year after transplantation. Method of measurement: Examination and following treatment.;Rate of treatment related mortality. Timepoint: One year after transplantation. Method of measurement: Examination and following treatment.;Rate of acute GVHD. Timepoint: Three month after transplantation. Method of measurement: Examination and following treatment.