drugset / Trial / NCT03862157
Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Phase 1/2
Active not recruiting
40 enrolled
M.D. Anderson Cancer Center
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase I/II trial studies the best dose of venetoclax when given together with azacitidine and pevonedistat and to see how well it works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Pevonedistat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine, venetoclax, and pevonedistat may work better in treating patients with acute myeloid leukemia.
Timeline
- Start
- 2019-02-27
- Primary completion
- 2027-01-31
- Completion
- 2027-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Pevonedistat | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Venetoclax | Small molecule | 200 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |
Indications
acquired polycythemia vera
acute myeloid leukemia
atypical chronic myeloid leukemia, BCR-ABL1 negative
chronic eosinophilic leukemia
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
essential thrombocythemia
myelodysplastic syndrome
myelofibrosis
myeloproliferative neoplasm, unclassifiable
primary myelofibrosis