OncoMatch/Clinical Trials/NCT05735184
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML
Is NCT05735184 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for acute myeloid leukemia.
Treatment: Ziftomenib · Venetoclax · Azacitidine · Daunorubicin · Cytarabine · Quizartinib — Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations. This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion. The purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Sarcoma
Biomarker criteria
Required: NPM1 mutation
documented NPM1 mutation
Required: KMT2A (MLL) rearrangement
KMT2A rearrangement
Required: FLT3 ITD+ with an allelic ratio ≥0.05 (allelic ratio ≥0.05)
FLT3-ITD+ with an allelic ratio ≥0.05 and eligible for FLT3-targeted treatment (Arm C)
Excluded: BCR ABL alteration
Known history of BCR-ABL alteration [excluded]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy for leukemia
Exception: hydroxyurea and/or leukapheresis and/or up to 2 doses of cytarabine per institutional standards to control leukocytosis; prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia
For newly diagnosed cohorts: received prior chemotherapy for leukemia, except hydroxyurea and/or leukapheresis and/or up to 2 doses of cytarabine per institutional standards to control leukocytosis, or prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia
Cannot have received: chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational
For relapsed/refractory cohorts: received chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational < 14 days prior to the first dose of ziftomenib or within 5 drug half-lives prior to the first dose of study drug
Lab requirements
Kidney function
adequate renal function according to protocol defined criteria
Liver function
adequate liver function according to protocol defined criteria
Cardiac function
adequate cardiac function according to protocol defined criteria; QTcF Arm A/B >480 ms, Arm C >450 ms excluded
Adequate liver, renal, and cardiac function according to protocol defined criteria; Mean QT interval corrected for heart rate by Fredericia's formula (QTcF): Arm A and Arm B: >480 ms on triplicate ECGs; Arm C: >450 ms on triplicate ECGs
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic - Phoenix · Phoenix, Arizona
- Moores UC San Diego Cancer Center · La Jolla, California
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
- UCLA - Bowyer Oncology Center · Los Angeles, California
- UC Irvine Health Chao Family Comprehensive Cancer Center · Orange, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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