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NotablePrimary endpoints: details revised at 2 of 4 entriesTrial sites expanded: 115 → 122 locations · Eligibility criteria expanded, about 27 words · Secondary endpoints: details revised at 4 of 13 entries · 1 moreShow 4 more changesShow less
Trial sites expanded: 115 → 122 locations
Eligibility criteria expanded, about 27 words
Secondary endpoints: details revised at 4 of 13 entries
Study description expanded, about 5 words
MinorTrial sites expanded: 106 → 115 locationsv14
MinorTrial sites expanded: 82 → 106 locationsv13
MinorTrial sites expanded: 71 → 82 locationsv12
MinorTrial sites expanded: 53 → 71 locationsv11
MinorTrial sites expanded: 39 → 53 locationsv10
MinorTrial sites expanded: 29 → 39 locationsv9
MinorStudy sites: 26 to 29v8
MinorStudy sites: 20 to 26Eligibility criteria revisedv7Show 1 more changeShow less
MinorStudy sites: 14 to 20Secondary endpoints: details revised at 2 of 13 entriesv6Show 1 more changeShow less
Secondary endpoints: details revised at 2 of 13 entries
MinorStudy sites: 8 to 14v5
MinorStudy sites: 2 to 8v4
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 2 · Start date changed from estimate of Sep 2025 to Sep 26, 2025v3Show 2 more changesShow less
Study sites: 0 to 2
Start date changed from estimate of Sep 2025 to Sep 26, 2025
MinorRe-verified, no change to tracked fieldsv2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
The physician will determine which study is the appropriate treatment for the patient, but neither the patient nor their physician will know whether the patient has been assigned to receive ziftomenib or a placebo. This design is called "double-blinded".