Studies to Assess Ziftomenib with Ven+Aza or 7+3 in Untreated AML

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1012377

• Contact name

  Hunkar Dag

• Contact email

  hdag@kuraoncology.com

• Sponsor organisation

  Kura Oncology Inc

• Eudract number

  0000-000000-00

• Clinicaltrials.gov Identifier

  NCT07007312

• Research summary

  This trial includes 2 independent Phase 3, randomized, double-blind, placebo-controlled studies in patients with untreated AML. The nonintensive therapy study examines ziftomenib in combination with venetoclax (ven)+azacitidine (aza) for NPM1-m AML. Participants will be randomly assigned to treatment with either ziftomenib in combination with ven+aza or placebo in combination with ven+aza. The intensive therapy study examines ziftomenib in combination with cytarabine+daunorubicin (7+3) induction, cytarabine consolidation, and the impact of ziftomenib maintenance therapy for participants with either NPM1-m or KMT2A-r AML. Participants in this study will be randomly assigned to 1 of 3 treatment arms: Arm A-ziftomenib in combination with 7+3 induction, followed by ziftomenib+cytarabine consolidation, followed by ziftomenib maintenance; Arm B-ziftomenib in combination with 7+3 induction, followed by ziftomenib+cytarabine consolidation, followed by placebo maintenance; or Arm C-placebo in combination with 7+3 induction, followed by placebo+cytarabine consolidation, followed by placebo maintenance.
  The main objective of the nonintensive study is to determine if ziftomenib combined with ven+aza improves participant survival in untreated NPM1-m AML. The key secondary objective is to determine if ziftomenib combined with ven+aza improves the response rates of untreated NPM1-m AML. Other secondary objectives are summarized in the protocol.
  The main objective of the intensive study is to determine if ziftomenib combined with 7+3 improves participant survival in untreated NPM1-m and KMT2A-r AML. The key secondary objectives are to determine if ziftomenib combined with 7+3 improves response rates of untreated NPM1-m AML, and to evaluate the effect of ziftomenib combined with 7+3 on participant survival in untreated NPM1-m and KMT2A-r AML. Other secondary objectives are summarized in the protocol.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  25/SC/0367

• Date of REC Opinion

  18 Dec 2025

• REC opinion

  Further Information Favourable Opinion