drugset / Trial / NCT02461121
HLA-mismatched MST vs HLA-matched NST for AML in Intermediate-risk
Phase 3
Completed
156 enrolled
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
RandomizedParallel-groupOpen-labelTreatment
Summary
Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.
Timeline
- Start
- 2004-05
- Primary completion
- 2013-05
- Completion
- 2013-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anti-lymphocyte globulin | Unknown | 1.5 mg/kg | — |
| Comparator | Anti-lymphocyte globulin | Unknown | 2 mg/kg | — |
| Comparator | Cyclophosphamide | Other / unclassified | 40 mg/kg | — |
| Subject | Cytarabine | Small molecule | 2000 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 2500 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 3000 mg/m2 | Intravenous |
| Comparator | Fludarabine | Small molecule | 30 mg/m2 | — |
| Comparator | HLA matched stem cell | Cell therapy | — | Other |
| Subject | Microtransplantation | Cell therapy | — | Other |
| Comparator | Cyclosporine | Peptide | — | — |
| Comparator | Mycophenolate Mofetil | Small molecule | — | — |