drugset / Trial / NCT05079230
Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia
RandomizedParallel-groupDouble-blindTreatment
Summary
The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy.
Timeline
- Start
- 2022-07-07
- Primary completion
- 2024-04-11
- Completion
- 2024-04-11
Publications
- Daver N, Vyas P, Huls G, Dohner H, Maury S, Novak J, Papayannidis C, Martinez Chamorro C, Montesinos P, Niroula R, Fenaux P, Esteve J, Wu SJ, De Voeght A, Mayer J, Valk PJM, Johnson L, Dong M, Liu K, Kuwahara S, Caldwell K, Guru Murthy GS. The ENHANCE-3 study: venetoclax and azacitidine plus magrolimab or placebo for untreated AML unfit for intensive therapy. Blood. 2025 Jul 31;146(5):601-611. doi: 10.1182/blood.2024027506.
- Daver NG, Vyas P, Kambhampati S, Al Malki MM, Larson RA, Asch AS, Mannis G, Chai-Ho W, Tanaka TN, Bradley TJ, Jeyakumar D, Wang ES, Sweet K, Kantarjian HM, Garcia-Manero G, Komrokji R, Xing G, Ramsingh G, Renard C, Zeidner JF, Sallman DA. Tolerability and Efficacy of the Anticluster of Differentiation 47 Antibody Magrolimab Combined With Azacitidine in Patients With Previously Untreated AML: Phase Ib Results. J Clin Oncol. 2023 Nov 1;41(31):4893-4904. doi: 10.1200/JCO.22.02604. Epub 2023 Sep 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Magrolimab | Monoclonal antibody | 30 mg/kg | Intravenous |
| Background | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Background | Venetoclax | Small molecule | 400 mg | Oral |