Haploidentical hematopoietic stem cell transplantation in combination with posttransplant cyclophosphamide and ATG-thymoglobulin Phase I study
Phase 1
- Conditions
- hematological malignancy
- Registration Number
- JPRN-UMIN000009374
- 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
- 15
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Organ dysfunction (2) Uncontrolled hypertension (3) HIV positive (4) Uncontrolled active infection (5) Uncontrolled CNS invasion (6) Pregnant (7) Psychiatric disorder (8) Allergy to drugs used for HSCT (9) Other reason which physicians think the patient is inappropriate for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Day 60 engraftment and survival 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) engraftment rate (5) acute and chronic GVHD (6) regimen-related toxicity (CTCAE ver 4.0) (7) relapse rate (8) infectious disease (9) immune reconstitution