drugset / Trial / NCT03625505
A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia
Non-randomizedSequentialOpen-labelTreatment
Summary
A dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and efficacy of venetoclax, in combination with gilteritinib, in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) who have failed to respond to, and/or have relapsed or progressed after at least 1 prior therapy.
Timeline
- Start
- 2018-10-18
- Primary completion
- 2021-08-31
- Completion
- 2021-08-31
Publications
- Kennedy VE, Peretz CAC, Walia A, Chyla B, Sun Y, Hill JE, Tran E, Koh AD, Ferng TT, Pintar S, Jones M, Popescu B, Lomeli I, Chehab F, Murad N, John A, Roy RP, Olshen AB, Berryhill CA, Davis C, Angus SP, Rivera JM, Meshulam A, Stieglitz E, Joshi SK, Traer E, Dail M, Hamidi H, Altman JK, Daver NG, Levis MJ, McCloskey J, Perl AE, Smith CC. Dynamic genetic and nongenetic RAS pathway activation drives resistance to FLT3 and BCL2 inhibitor therapy. Blood. 2026 Jun 1:blood.2025032466. doi: 10.1182/blood.2025032466. Online ahead of print.
- Daver N, Perl AE, Maly J, Levis M, Ritchie E, Litzow M, McCloskey J, Smith CC, Schiller G, Bradley T, Tiu RV, Naqvi K, Dail M, Brackman D, Siddani S, Wang J, Chyla B, Lee P, Altman JK. Venetoclax Plus Gilteritinib for FLT3-Mutated Relapsed/Refractory Acute Myeloid Leukemia. J Clin Oncol. 2022 Dec 10;40(35):4048-4059. doi: 10.1200/JCO.22.00602. Epub 2022 Jul 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gilteritinib | Small molecule | 80 mg | Oral |
| Subject | Gilteritinib | Small molecule | 120 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |