Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies

Summary

This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies. Venetoclax and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Giving ivosidenib and venetoclax with azacitidine may work better in treating patients with hematologic malignancies compared to ivosidenib and venetoclax alone.

Timeline

Start

2018-03-19

Primary completion

2027-09-30

Completion

2027-09-30

Publications

• DiNardo CD, Marvin-Peek J, Loghavi S, Takahashi K, Issa GC, Jen WY, Daver NG, Reville PK, Short NJ, Sasaki K, Mullin JK, Bradley CA, Borthakur G, Maiti A, Alvarado Y, Pemmaraju N, Abbas HA, Hammond DE, Haddad F, Bravo GM, Chien KS, Yilmaz M, Kornblau SM, Jabbour E, Ravandi F, Kadia T, Garcia-Manero G, Konopleva MY, Kantarjian HM. Outcomes of Frontline Triplet Regimens With a Hypomethylating Agent, Venetoclax, and Isocitrate Dehydrogenase Inhibitor for Intensive Chemotherapy-Ineligible Patients With Isocitrate Dehydrogenase-Mutated AML. J Clin Oncol. 2025 Aug 20;43(24):2692-2699. doi: 10.1200/JCO-25-00640. Epub 2025 Jun 13.
• Greenberg PL, Stone RM, Abaza Y, Al-Kali A, Anand S, Ball B, Bennett JM, Borate U, Brunner AM, Chai-Ho W, Curtin P, DeZern AE, Gaensler K, Gahvari Z, Garcia-Manero G, Griffiths EA, Haque T, Jacoby M, Jonas BA, Keel S, Khanal R, Kishtagari A, Madanat Y, Maness LJ, McCurdy SR, McMahon C, Odenike O, Osman A, Reddy VV, Sallman DA, Sayar H, Shallis R, Singh A, Tanaka T, Thota S, Kovach E, Nguyen J, Hochstetler C. NCCN Guidelines(R) Insights: Myelodysplastic Syndromes, Version 2.2025. J Natl Compr Canc Netw. 2025 Mar;23(3):66-75. doi: 10.6004/jnccn.2025.0013.
• Wilde L, Kasner M. Whom should we treat with novel agents? Specific indications for specific and challenging populations. Hematology Am Soc Hematol Educ Program. 2021 Dec 10;2021(1):24-29. doi: 10.1182/hematology.2021000228.

Drugs

Indications