drugset / Trial / NCT03318016
Arsenic Trioxide With Cyclophosphamide in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Non-randomizedSequentialOpen-labelTreatment
Summary
Determine the maximum tolerated dose (MTD) and toxicity profile of the combination of cyclophosphamide and ATO (Arsenic Trioxide) in subjects with relapsed refractory AML. Determine the efficacy of ATO and cyclophosphamide in this population, as defined by response rate, response duration, event-free survival (EFS) and overall survival (OS). Determine the number of transplant-eligible subjects who are successfully bridged to stem cell transplantation or donor lymphocyte infusion.
Timeline
- Start
- 2017-12-15
- Primary completion
- 2020-01-15
- Completion
- 2021-01-20
Outcome
Outcome not reported
Stopped (Enrollment): “Low enrollment, University Scientific Review Committee required study closure.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 1000 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 2000 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 3000 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 4000 mg/m2 | Intravenous |