A phase II study of the dose reduction and shortening of duration of immunosuppressant after HLA-haploidentical transplantation with post-transplantation cyclophosphamide following reduced-intensity conditioning
Not Applicable
Recruiting
- Conditions
- hematologic malignancies
- Registration Number
- JPRN-UMIN000026002
- Lead Sponsor
- JSCT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients who are positive for HBs antigen, HCV antibody, or 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. Positive anti-donor HLA antibody. 7. Patients who need chemotherapy within 13 days before transplantation. 8. Patients whose body mass index is >=30. 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 on-relapse mortality at 180 days
- Secondary Outcome Measures
Name Time Method 1. Engraftment at 100 days. 2. The incidence of acute GVHD and chronic GVHD at 180 days, 1 year, and 2 years. 3. Non-relapse mortality at 1 year, and 2 years. 4. The incidence of relapse at 180 days, 1 year, and 2 years. 5. Disease-free survival at 180 days, 1 year, and 2 years. 6. Overall survival at 180 days, 1 year, and 2 years. 7. The incidence of infectious event at 180 days, 1 year, and 2 years. 8. GVHD free, relapse free survival (GRFS) at 180 days, 1 year, and 2 years. 9. The proportion of patients who stopped immunosuppressive drugs within 180 days, 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 disease risk index (DRI)