drugset / Trial / NCT06351306
DEC-C and Thioguanine for R/R AML
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to find out if oral decitabine-cedazuridine (Inqovi®) is effective, safe, and able to be tolerated without severe side effects when given with thioguanine (Tabloid®) in patients with acute myeloid leukemia (AML) whose disease has returned or did not respond to treatment (relapsed or refractory). This is a "phase II trial with a safety lead-in." The goal of the lead-in portion of the study is to make sure participants are getting the highest dose of medications that are safe. If too many serious side effects are seen with the dose previously studied, some additional patients may be treated with a lower dose to make sure that this dose is safe.
Timeline
- Start
- 2024-04-01
- Primary completion
- 2024-04-01
- Completion
- 2024-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cedazuridine | Small molecule | 100 mg | Oral |
| Subject | Decitabine | Small molecule | 35 mg | Oral |
| Subject | Thioguanine | Small molecule | 60 mg/m2 | Oral |
| Subject | Thioguanine | Small molecule | 80 mg/m2 | Oral |