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HLA-haploidentical allogeneic stem cell transplantation for Adult T-cell leukemia/lymphoma (ATL/L) and refractory aggressive lymphoma

Phase 2
Conditions
Adult T-cell leukemia/lymphoma (acute type and lymphoma type) Malignant lymphoma (aggressive hodgkin and non-hodgkin lymphoma)
Registration Number
JPRN-UMIN000002606
Lead Sponsor
Hematology, Osaka City University, Graduate School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
17
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 3 months, liver cirrhosis and interstitial pneumonia 7) Pregnant, nursing or possible fertile woman 8) Patients with mental disorder or neurological disorder who are likely to unable to participate in the study 9) A history of hypersensitivity or allergy to any drugs in conditioning regimen of this transplant 10) HIV antibody positivity 11) Patients with history of administration of mogamulizumab 12) No indication for this study judged by physician in charge. (Note: HBs antigen positivity and HCV antibody positivity is not excluded.)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Engraftment rate
Secondary Outcome Measures
NameTimeMethod
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