A prospective non-randomized phase II study to assess the efficacy of unrelated cord blood transplantation for adult unfavorable hematological malignancies (C-SHOT 0601)
Phase 2
- Conditions
- Patients with acute myeloid leukemia/acute lymphocytic leukemia/myelodysplastic syndrome/chronic myelomonocytic leukemia categorized as high risk group
- Registration Number
- JPRN-UMIN000000600
- Lead Sponsor
- agoya Blood and Marrow Transplantation Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
(1)Positive for HIV antibody and/or HBs antigen and/or HCV antibody (2)Graft manipulation such as T-cell depletion (3)history of administration of gemtuzumab ozogamicin within 6 month before transplantation (4)Pregnant or during breast feeding (5)Uncontrolled another neoplastic disease (6)Uncontrolled active psychiatric disease (7)Uncontrolled active infection (8)Allergic history to drugs used in the conditioning regimen or GVHD prophylaxis regimen (9)Patients suggested as ineligible by their attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method survival rate of patients with successful engraftment at 180 days post-transplant
- Secondary Outcome Measures
Name Time Method Time to hematopoietic recovery, grade of treatment-associated toxicity by day28, incidence and severity of acute GVHD, incidence and severity of chronic GVHD, treatment-related mortality rate at day180, relapse rate at day180, disease-free survival 2years after transplantation, overall survival 2years after transplantation.