JPRN-UMIN000009766
Completed
Phase 2
Phase II study of allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and fludarabine as conditioning regimen - IVBU1002(FB4): Phase II study of once daily ivBu+Flu
Hematopoietic Stem Cell Transplantation Division, National Cancer Center Hospital0 sites75 target enrollmentJanuary 21, 2013
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- acute myeloid leukemia(AML) myelodysplastic syndrome(MDS) chronic myelogenous leukemia(CML)
- Sponsor
- Hematopoietic Stem Cell Transplantation Division, National Cancer Center Hospital
- Enrollment
- 75
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •(1\) Patients who have one of the following organ dysfunction 1\) SPO2\<90% by room air, %VC\=\<30% or FEV1\.0%\=\<40% 2\) sCr\>2\.0mg/dL 3\) T\-bil\>2\.0mg/dL 4\) AST, ALT or ganma\-GTP\>3 x upper limit of normal range 5\) Ejection fraction of left ventricle\<40% by UCG (2\) Patients with uncontrolled diabetes mellitus in spite of regular use of insulin (3\) Patients with uncontrolled hypertension in spite of use of antihypertensive drugs (4\) Patients who have active infection (5\) Patients who are positive for TPHA, HBV surface antigen or anti\-HCV antibody (6\) Patients who are positive for anti\-HTLV\-I or anti\-HIV antibody (7\) Patients who are not evaluated to be able to survive more than 100 days after transplantation (8\) Patients who have coinciding active malignancies (9\) 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 (10\) Patients who have psychiatric disorder (11\) Patients who have prior hematopoietic stem cell transplantation (12\) Patients who are considered as inappropriate to register by attending physicians
Outcomes
Primary Outcomes
Not specified
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