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Phase 3Recruiting

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

Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia

Sponsor
Kura Oncology, Inc. (Industry)
Enrolment
1,300 planned
Conditions
Acute Myeloid Leukemia (AML)
Interventions
Ziftomenib; Placebo; Venetoclax; Azacitidine (AZA); Daunorubicin; Cytarabine (Ara-C)
Ages
adults, older adults
Registry
NCT07007312, CTIS2025-521314-25-00

Full record on ClinicalTrials.gov

From the registry

Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations. Ziftomenib is a type of therapy known to target the menin pathway in cancer cells. This protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML. In the first study, the Nonintensive Therapy Study, older patients or those with serious medical problems will receive the SOC therapies venetoclax (ven) and azacitidine (aza), plus either ziftomenib or a placebo. In the second study, the Intensive Therapy Study, medically fit patients will receive (a) the SOC therapies cytarabine and daunorubicin, plus either ziftomenib or a placebo during a first treatment phase called induction, (b) cytarabine plus either ziftomenib or a placebo during a second treatment phase called consolidation, and (c) ziftomenib or a placebo during a third treatment phase called maintenance.…

Primary outcomes

  • Nonintensive Therapy Study: (Primary Endpoint for all countries): Overall survival (OS)
  • Nonintensive Therapy Study: (Dual Primary Endpoint for US & US reference countries only): Complete remission (CR)
  • Intensive Therapy Study: (Primary Endpoint for all countries): Event-free survival (EFS)
  • 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

History

  1. Primary completion expected

  2. Last registry update

  3. Started

  4. Registered