A prospective study which assess the safety and efficiacy of haploidentical hematopoietic stem cell transplantation using posttransplant cyclophosphamide for adult T cell leukemia/lymphoma
Phase 1
- Conditions
- aggressive adult T cell leukemia/lymphoma
- Registration Number
- JPRN-UMIN000021783
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who meet any criteria below are ineligible (1) severe organ failure (2) uncontrolled hypertension (3) HIV infection (4) uncontrolled infection (5) uncontrolled CNS invasion (6) pregnant/lactating (7) psychological disorder (8) known allergy for drugs used as GVHD prophylaxis or conditioning regimen (9) history of administration of anti-CCR4 antibody (10) high titer of anti-donor specific HLA antibody (11) the physician considers inappropriate for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival at day 60 after transplantation with engraftment and without grade III-IV acute GVHD
- Secondary Outcome Measures
Name Time Method (1) 1-year OS/PFS (2) 1-year NRM (3) graft failure (4) time to engraftment, complete chimerism (5) acute/chronic GVHD (6) regimen-related toxicity CTCAE ver 4.0 (7) relapse rate (8) incidence of bacterial, fungal, viral infection (9) immune reconstitution