Haploidentical hematopoietic stem cell transplantation with posttransplant cyclophosphamide in combination with thymoglobulin (RIC version) Phase I
Phase 1
- Conditions
- Hematological malignancy
- Registration Number
- JPRN-UMIN000011004
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
(1) severe organ dysfunction (2) uncontrolled hypertenstion (3) HIV (4) uncontrolled active infection (5) uncontrolled CNS disease (6) pregnant (7) uncontrolled mental disorder (8) allergy to drugs used as conditioning regimen or GVHD prophylaxis (9) recent high-dose chemotherapy (10) patients whom the physician regard as inappropriate for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Day 60 survival with engraftment without grade III-IV acute GVHD
- Secondary Outcome Measures
Name Time Method (1) 1-year OS and PFS (2) 1-year NRM (3) graft failure (4) time to engraftment and complete donor chimerism (5) acute/chronic GVHD (6) regimen-related toxicity (CTCAE ver 4.0) (7) relapse (8) infection (bacterial, fungal, viral) (9) immune reconstitution