Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML

Study type

Interventional

Primary purpose

Treatment

Allocation

Randomized

Intervention model

Parallel

Masking

Quadruple

Arms

5

Interventions

• Ziftomenib Drug
• Placebo Drug
• Venetoclax Drug
• Azacitidine (AZA) Drug
• Daunorubicin Drug
• Cytarabine (Ara-C) Drug

• Acute Myeloid Leukemia (AML)

Primary outcome

Nonintensive Therapy Study: (Primary Endpoint for all countries): Overall survival (OS) (Defined as the time from randomization to date of death from any cause, assessed up to 36 months after last patient inclusion); Nonintensive Therapy Study: (Dual Primary Endpoint for US & US reference countries only): Complete remission (CR) (Assessed up to 36 months after last patient inclusion); Intensive Therapy Study: (Primary Endpoint for all countries): Event-free survival (EFS) (Defined as the time from randomization to treatment failure, hematologic relapse following CR, or death from any cause, whichever comes first, assessed up to 36 months after last patient inclusion); Intensive Therapy Study: (Dual Primary Endpoint for US & US reference countries only): Complete remission (CR) with bone marrow (BM) measurable residual disease (MRD) negativity in NPM1-m patients (Assessed up to 36 months after last patient inclusion)

• Ziftomenib

• NCT07007312 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read 25 Oct 2026

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.