A phase II study of haploidentical transplantation with post-transplantation cyclophosphamide following myeloablative conditioning
Not Applicable
- Conditions
- hematologic malignancies
- Registration Number
- JPRN-UMIN000020655
- Lead Sponsor
- JSCT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients who are positive for HIV antibody. 2. Patients with active other malignancies. 3. Patients with active infectious disease. 4. Women who are pregnant, of childbearing potential, or lactating. 5. Patients who experienced serious hypersensitivity or anaphylaxis to cyclophosphamide, fludarabine, tacrolimus, mycophenolate mofetil. 6. Patients who has a prior history of allogeneic transplantation. 7. Positive anti-donor HLA antibody. 8. Patients who need chemotherapy within 13 days before transplantation. 9. Patients who are not eligible for this study at the discretion of the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of grade III-IV acute GVHD at 100 days
- Secondary Outcome Measures
Name Time Method 1. Engraftment at 100 days. 2. The incidence of acute GVHD and chronic GVHD at 100 days, 1 year, and 2 years. 3. Non-relapse mortality at 100 days, 1 year, and 2 years. 4. The incidence of relapse at 100 days, 1 year, and 2 years. 5. Disease-free survival at 100 days, 1 year, and 2 years. 6. Overall survival at 100 days, 1 year, and 2 years. 7. The incidence of infectious event at 100 days, 1 year, and 2 years. 8. GVHD free, relapse free survival (GRFS) at 100 days, 1 year, and 2 years. 9. The proportion of patients who stopped immunosuppressive drugs within 1 year and 2 year. 10. Noninfectious fever within 7 days after transplantation 11. Grade 3-4 non-hematologic toxicity within 100 days. 12. Subgroup analysis subgroup analysis according to conditioning regimen. 13. Subgroup analysis subgroup analysis according to disease risk index (DRI)