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
Phase 3 – large-scale trial before approval
Conditions:
NPM1-m and KMT2A-r Acute Myeloid Leukemia
Sponsor: Kura Oncology Inc.
trial.available_in:
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Overview
Trial status: Authorised
Nonintensive Therapy Study - CR rate per the ELN 2022 criteria per Investigator assessment - Percentage of patients achieving centrally defined BM MRD negativity - Rates of CR+CRh per ELN 2022 per Investigator assessment, Intensive Therapy Study (7+3) - Percentage of patients achieving CR per ELN 2022 criteria with centrally defined BM MRD negativity (CRMRD-) - Overall survival (OS)
Nonintensive Therapy Study - Overall survival (OS) Intensive Therapy Study (7+3) - EFS, defined as the time from randomization to treatment failurea, hematologic relapse following CR, or death from any cause, whichever comes first
Description
Nonintensive Therapy Study - CR rate per the ELN 2022 criteria per Investigator assessment - Percentage of patients achieving centrally defined BM MRD negativity - Rates of CR+CRh per ELN 2022 per Investigator assessment, Intensive Therapy Study (7+3) - Percentage of patients achieving CR per ELN 2022 criteria with centrally defined BM MRD negativity (CRMRD-) - Overall survival (OS)
Who can participate
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 719 participants
Interventions
Ziftomenib Placebo
Drug
CYTARABINE
Drug
AZACITIDINE
Drug
CYTARABINE
Drug
VENETOCLAX
Drug
VENETOCLAX
Drug
Ziftomenib
Drug
VENETOCLAX
Drug
Daunoblastin® 20 mg Pulver zur Herstellung einer Infusions- oder Injektionslösung
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