JPRN-UMIN000011293
Completed
Phase 2
HLA-haploidentical allogeneic stem cell transplantation for refractory hematopoietic malignancies (OCU13-3) - HLA-haploidentical allogeneic stem cell transplantation for refractory hematopoietic malignancies (OCU13-3)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Acute myeloid leukemia(AML) Acute lymphoblastic leukemia (ALL) Chronic myeloid leukemia (CML) Myelodysplastic syndrome (MDS)
- Sponsor
- Osaka City University
- Enrollment
- 35
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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, coronary 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 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.)
Outcomes
Primary Outcomes
Not specified
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