Randomized phase II study of allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and cyclophosphamide as conditioning regime
- Conditions
- acute myeloid leukemia(AML) myelodysplastic syndrome(MDS) chronic myelogenous leukemia(CML)
- Registration Number
- JPRN-UMIN000009762
- Lead Sponsor
- Hematopoietic Stem Cell Transplantation Division, National Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 68
Not provided
(1) Patients with uncontrolled diabetes mellitus in spite of regular use of insulin (2) Patients with uncontrolled hypertension in spite of use of antihypertensive drugs (3) Patients who have active infection (4) Patients who are positive for TPHA, HBV surface antigen or anti-HCV antibody (5) Patients who are positive for anti-HTLV-I or anti-HIV antibody (6) Patients who are not evaluated to be able to survive more than 100 days after transplantation (7) Patients who have coinciding active malignancies (8) Patients who are pregnant or in the lactation period, and who are not able to, or not willing to prevent conception during the therapeutic period of this clinical trial (9) Patients who have psychiatric disorder (10) Patients who have prior hematopoietic stem cell transplantation (11) Patients who are considered as inappropriate to register by attending physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Probability of event-free survival at 1 year after transplantation
- Secondary Outcome Measures
Name Time Method (1) Incidence of Bearman's grade 2 or higher adverse events which occur from the begining of conditioning regimen to 28 days after transplantation (2) Cumulative incidence of engraftment at 100 days after transplantation (3) Cumulative incidence of non-relapse mortality at 100 days after transplantation (4) Cumulative incidence of SOS(sinusoidal obstrction syndrome) at 100 days after transplantation (5) Cumulative incidence of grade II-IV acute GVHD at 1 year after transplantation (6) Cumulative incidence of chronic GVHD at 1 year after transplantation (7) Probability of overall survival and cumulative incidence of relapse at 1 year after transplantation