A randomized trial comparing conventional GVHD prophylaxis vs. anti-thymocyte globulin-combined GVHD prophylaxis in HLA 1-locus mismatched unrelated bone marrow transplantation.
Phase 3
Recruiting
- Conditions
- Acute myeloid leukemia Acute lymphoblastic leukemia Adult T cell leukemia Chronic myelogenous leukemia Myelodysplastic syndrome Non-Hodgkin lymphoma Hodgkin lymphoma
- Registration Number
- JPRN-UMIN000028008
- Lead Sponsor
- Clinical research committee of the Japan Society for Hematopoietic Cell Transplantation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
Not provided
Exclusion Criteria
1. Presence of donor-specific HLA antibodies 2. Patients with HBs antibody positive 3. Patients with HIV antibody positive 4. Patients with serious mental disorder who are likely unable to participate in the study 5. Patients who are pregnant, nursing, or possibly pregnant 6. Patients with coexistence of malignancy 7. Patients with poorly controlled active infection 8. Patients who are allergic to ATG 9. Prior history of allogeneic hematopoietic cell transplantation within 1 year
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success rate at 1 year after transplantation (Success is defined as the situation without the following events within 1 year after transplantation 1. Death 2. Relapse 3. Grades III-IV acute GVHD 4. Severe chronic GVHD or mild chronic GVHD requiring systemic steroid treatment)
- Secondary Outcome Measures
Name Time Method