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Clinical Trials/JPRN-UMIN000026028
JPRN-UMIN000026028
Completed
未知

Allogeneic hematopoietic stem cell transplantation (HSCT) from HLA-haploidentical related donor using reduced dose of posttransplantation high-dose cyclophosphamide (PTCy) for poor prognosis or refractory hematological malignancies (OCU16-2) - HLA-haploidentical HSCT with reduced dose of PTCy (OCU16-2)

Osaka City University0 sites33 target enrollmentFebruary 8, 2017

Overview

Phase
未知
Intervention
Not specified
Conditions
Acute myeloid leukemia(AML) Acute lymphoblastic leukemia(ALL) Acute leukemias of ambiguous lineage Myelodysplastic syndrome(MDS) Chronic myeloid leukemia(CML) Adult T-cell leukemia/lymphoma(ATLL) Malignant lymphoma(ML)
Sponsor
Osaka City University
Enrollment
33
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 8, 2017
End Date
April 30, 2021
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 1\) Major organ dysfunction a) Total bilirubin: \>\= 2\.0 mg/dl b) Serum creatinine: \>\= 2\.0 mg/dl c) Left ventricular 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 woman or woman of childbearing potential 8\) Patients with a severe mental disorder 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\) A history of administration of mogamulizumab 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)

Outcomes

Primary Outcomes

Not specified

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