A phase II study of HLA matched related bone marrow or peripheral blood stem cell transplantation for elderly patients with hematologic malignancies using fludarabine and intravenous busulfan.
- Conditions
- AML,MDS
- Registration Number
- JPRN-UMIN000004213
- Lead Sponsor
- Japan Study Group for Cell Therapy and Transplantation
- Brief Summary
142 elderly patients (88 men and 54 women; median age, 61 years; range, 55-70 years) were participated, 103 AML and 39 MDS. 21 received related bone marrow (BM) or peripheral blood (PB), 50 did unrelated BM, and 71 did cord blood (CB). 105 (74%) experienced grade III or greater toxicities including 4 SOS. Neutrophil engraftment was achieved in 70 out of 71 related BM/PB or unrelated BM recipients, and 61 of 71 UCB recipients. Cumulative incidences of relapse and non-relapse mortality after 2 years were 24 % and 24.1%, respectively. Overall and event-free survivals at 2 years were 53.3% and 47.4 %, respectively. 2-year OS was 61.5% in related BM/PB, 67.8% in UBM, and 40.8% in CB recipients, showing inferior OS in CB recipients to the other donor types (P<0.05). However, for those in good performance status (ECOG 0) and had low blast count in BM (<5%), the differences became not significant (2-year OS were 77.3% in related BM/PB, 68.4% in UBM, and 65.0% in CB recipients). Conclusion: The myeloablative dose of ivBu was well tolerated without increased toxicity-related mortality. The differences between CB and the others could likely be due to relatively poor conditions of CB recipients. This trial was registered as #UMIN000002426, #UMIN000004213, and #UMIN000004211.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 42
Not provided
1.Those who are positive for anti-HIV antibody 2.Those who have history of gemtuzumab ozogamicin (MylotargTM) use within 4 months 3.Those who have coinciding active malignancies 4.Those who have uncontrolled psychiatric disorder 5.Those who have active infection 6.Those who have prior hematopoietic stem cell transplantation 7.Those who have history of chemotherapy within 30 days before transplant (except hydroxycarbamide or cytarabine therapy for blast control) 8.Those who have hypersensitivity to drugs included in this protocol therapy 9.Those who are considered as inappropriate to register by attending physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event-free survival at 1 year after transplantation
- Secondary Outcome Measures
Name Time Method