A phase II trial of targeted busulfan and cyclophosphamide conditioning for allogeneic hematopoietic stem cell transplantation for hematological malignancies
Phase 2
- Conditions
- Chronic Myelogenous Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Registration Number
- JPRN-C000000156
- Lead Sponsor
- agoya Blood and Marrow Transplantation Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Uncontrollable and active infection (2) Positivity for HIV antibody and/or HBs antigen and/or HCV antibody (3) Graft manipulation such as T cell depletion (4) Impaired organ function (kidney; serum creatinine >2.0 mg/dl, Liver; aspartate aminotransferase more than 5 times high than upper limit or serum bilirubin >2.0mg/dl, heart; left ventricular ejection fraction less than 50%, lung; arterial oxygen saturation < 93% without oxygen inhalation.) (5) History of drug allergy used in the present conditioning or GVHD prophylaxis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival at one year after transplantation
- Secondary Outcome Measures
Name Time Method Disease-free survival, overall survival, pharmacokinetics of busulfan, incidence and severity of acute GVHD, incidence and severity of chronic GVHD, incidence and severity of hepatic veno-occlusive disease, mortality rate at 100 days after transplantaion, time to hematopoietic recovery, overall survival and disease-free survival in each disease group