Posttransplantation cyclophosphamide and tacrolimus for prevention of Graft-versus-host disease in allogeneic hematopoietic stem cell transplantation from HLA matched sibling or unrelated donor: a single center prospective phase II study (OCU16-1)
- Conditions
- Acute myeloid leukemia(AML) Acute lymphoblastic leukemia(ALL) Acute leukemias of ambiguous lineage Myelodysplastic syndrome(MDS) Chronic myeloid leukemia(CML) Malignant lymphoma(ML)
- Registration Number
- JPRN-UMIN000023890
- Lead Sponsor
- Osaka City University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 39
Not provided
1) Major organ dysfunction a) Total bilirubin:>= 2.0mg/dl b) Serum creatinine: >= 2.0mg/dl c) Ejection fraction: < 50 % d) Pulmonary function test: %VC <40%, FEV1.0% <50% or SaO2 <90% on room air e) AST or ALT >= 3 x UNL 2) Uncontrolled active infection 3) Uncontrolled CNS invasion 4) Poorly controlled insulin-treated diabetes mellitus 5) Poorly controlled hypertension 6) Patients with a severe complication including heart failure, liver failure, acute myocardial infarction within the last three months, liver cirrhosis and interstitial pneumonia 7) Pregnant, lactating or possible fertile women who may become pregnant 8) Patients with a severe mental who are likely to be unable to participate in the study 9) A history of hypersensitivity or allergy to any drugs in the conditioning regimen of this transplant 10) HIV antibody positivity 11) The administration of ATG is scheduled in conditioning regimen. 12) The physician in charge determines that there is no indication to perform this intervention. (Note: HBs antigen positivity and HCV antibody positivity is not exclusion criterion.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 year chronic GVHD cumulative incidence
- Secondary Outcome Measures
Name Time Method