drugset / Trial / NCT05360160
A Phase I-II Study Investigating the All-Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)
Phase 1/2
Recruiting
43 enrolled
M.D. Anderson Cancer Center
Astex Pharmaceuticals, Inc. · collabSyndax Pharmaceuticals · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Part 1b of this clinical research study is to find the highest tolerable dose of SNDX-5613 that can be given in combination with ASTX727 (a combination of the drugs decitabine/cedazuridine) and venetoclax for patients with acute myeloid leukemia (AML) or those with a mixed phenotype acute leukemia with a myeloid phenotype (MPAL). Part 2 of this study is to learn if the dose of study drugs found in Part 1b can help to control AML/MPAL
Timeline
- Start
- 2022-10-14
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
Publications
- Issa GC, Cuglievan B, El Hajjar G, Jen WY, Bataller A, Short NJ, DiNardo CD, Alvarado Y, Loghavi S, Duose DY, Zhang B, Furudate K, Ning J, Xiao L, Mouhayar E, Pinto A, Bidikian A, Thompson E, Daver N, Garcia-Manero G, Farhat A, McCall D, Kadia TM, Abbas HA, Tan S, Bazinet A, Jabbour E, Montalban-Bravo G, Ravandi F, Takahashi K, Andreeff M, Kantarjian HM. All-Oral Combination of Revumenib, Decitabine, and Venetoclax for Relapsed or Refractory AML (SAVE). J Clin Oncol. 2026 Aug;44(22):2110-2120. doi: 10.1200/JCO-26-01159. Epub 2026 Jun 11.
- Garcia MB, Wang B, Sheikh I, El Hajjar G, McCall D, Nunez C, Gibson A, Lorenzi PL, Issa GC, Cuglievan B, Abbas HA. High-Throughput Proteomic Profiling to Evaluate Differentiation Syndrome With Menin Inhibition. Mol Cell Proteomics. 2026 Mar;25(3):101522. doi: 10.1016/j.mcpro.2026.101522. Epub 2026 Jan 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SNDX-5613 | Unknown | — | Oral |
| Background | ASTX727 | Unknown | — | Oral |
| Background | Venetoclax | Small molecule | — | Oral |