A Phase 1B Investigator Initiated Study of Safety and Tolerability of Dexamethasone (D) in Combination With Venetoclax-based Low-Intensity Therapy (LIT) in Treatment-Naïve Acute Myeloid Leukemia (AML): DLIT-AML
Summary
This study is investigating whether adding dexamethasone, an anti-inflammatory medication, to a standard venetoclax-based low-intensity therapy (LIT) is safe and well-tolerated in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are not eligible for intensive chemotherapy. Study Goals Primary Goal: To assess the safety and tolerability of dexamethasone in combination with venetoclax-based LIT. Secondary Goal: To evaluate how this treatment affects patients' quality of life using surveys. Exploratory Goal: To measure the treatment response, including remission rates and signs of minimal residual disease. What Happens in the Study? Patients will receive treatment over six cycles. Dexamethasone is given in different doses during the first six cycles along with venetoclax and another standard chemotherapy drug.
Timeline
- Start
- 2025-09-01
- Primary completion
- 2029-06
- Completion
- 2029-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Azacitidine | Other / unclassified | — | — |
| Background | Cytarabine | Small molecule | — | — |
| Background | Decitabine | Small molecule | — | — |
| Background | Venetoclax | Small molecule | — | — |