GFM-Acadesine: A Phase I-II Trial of Acadesine
Summary
A phase I-II trial of Acadesine in IPSS high and int 2 myelodysplastic syndromes, acute myeloid leukemia with 20-30% marrow blasts and chronic myelomonocytic leukemia type 2 not responding to Azacitidine or Decitabine for at least 6 courses or relapsing after a response: Patients will receive 6 treatment cycles unless disease progression, transformation, or unacceptable toxicity occurs, or the patient refuses to continue participating in the study. Efficacy will be assessed at the end of the 2nd, 4th and 6th cycles. After 6 cycles, patients demonstrating a response (CR, PR, marrow CR, or HI) will be able to continue with cycles of Acadesine (at the same dose as in the preceding cycles, depending on their cohort) until progression.
Timeline
- Start
- 2013-06
- Primary completion
- 2013-06
- Completion
- 2015-06
Outcome
Outcome not reported
Stopped: “Renal toxicity”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acadesine | Small molecule | 85 mg/kg | Intravenous |
| Subject | Acadesine | Small molecule | 140 mg/kg | Intravenous |
| Subject | Acadesine | Small molecule | 210 mg/kg | Intravenous |
| Subject | Acadesine | Small molecule | 315 mg/kg | Intravenous |
Indications
No indication recorded.