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
Recruiting
Phase 1
Interventional Study
Acute Myeloid Leukemia
Mixed Lineage Leukemia Gene Mutation
Refractory AML
AML With Mutated NPM1
Acute Myeloid Leukemia Recurrent
Acute Myeloid Leukemia, in Relapse
NPM1 Mutation
KMT2Ar
Myeloid Sarcoma
Nucleophosmin 1-mutated Acute Myeloid Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 420 (estimated)
- Sponsor
- Kura Oncology, Inc. · Industry
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About This Trial
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 pati…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* Patients must have a documented NPM1 mutation or KMT2A rearrangement and have either newly diagnosed or relapsed/refractory AML
* Those intending treatment with intensive chemotherapy in Arm C should be NPM1-m and FLT3-ITD+ with an allelic ratio ≥0.05 and eligible for F…
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