Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes
Phase 1
Completed
- Conditions
- Myelodysplastic Syndromes
- Interventions
- Biological: Microtransplantation
- Registration Number
- NCT01674985
- Lead Sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Brief Summary
The purpose of this study is to investigate whether infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
- patients 10 to 90 years old with primary or treatment-related MDS or chronic myelomonocytic leukemia;
- International Prognostic Scoring System(IPSS) intermediate-1,intermediate-2,or high risk;
- bone marrow blasts > 11% or <= 10% and poor cytogenetics;
- lack of an HLA-identical donor;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- adequate cardiac and hepatorenal functions.
Exclusion Criteria
- have an HLA-identical donor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Decitabine and cytarabine Microtransplantation induction therapy：decitabine 25mg/m2 daily for 4 days with cytarabine 150 mg/m2 daily for 7 days consolidation：decitabine 25mg/m2 daily for 4 days with cytarabine 2g/m2 q12h for 3 days
- Primary Outcome Measures
Name Time Method complete remission six months
- Secondary Outcome Measures
Name Time Method disease-free survival three years
Trial Locations
- Locations (1)
Affiliated Hospital of Academy of Military Medical Sciences
🇨🇳Beijing, Beijing, China