Study on Ziftomenib with Standard Treatments for Untreated Acute Myeloid Leukemia (AML) with Specific Genetic Changes
Sponsor: Kura Oncology, Inc.
ClinicalTrials ID:NCT07007312
This clinical trial is testing a new drug, Ziftomenib, combined with standard treatments for patients with acute myeloid leukemia (AML) who have certain genetic mutations and have not yet received any treatment. The study aims to see if adding Ziftomenib can improve treatment outcomes.
Patient Parameters
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Program Overview
Ziftomenib is an experimental drug being tested for treating acute myeloid leukemia (AML) in patients with specific genetic changes. This study includes two separate parts to explore the benefits and risks of adding Ziftomenib to standard AML treatments for patients who haven't been treated before. In one part, older patients or those with serious health issues will receive standard therapies, venetoclax and azacitidine, with either Ziftomenib or a placebo. In the other part, healthier patients will receive standard therapies, cytarabine and daunorubicin, with either Ziftomenib or a placebo during different treatment phases. Neither the patients nor their doctors will know if they are receiving Ziftomenib or a placebo, which is called a "double-blind" study.
Description
This study involves two main parts, both testing the effectiveness and safety of Ziftomenib combined with standard treatments for AML.
Nonintensive Therapy Study (Ven+Aza):
- Patients with a specific genetic mutation (NPM1-m) will be randomly assigned to receive either Ziftomenib with venetoclax and azacitidine or a placebo with these standard drugs. This part is for older patients or those with serious health issues.
Intensive Therapy Study (Cytarabine+Daunorubicin):
- Patients with specific genetic mutations (NPM1-m or KMT2A-r) will be randomly assigned to one of three groups:
- Group A: Ziftomenib with standard drugs during all treatment phases.
- Group B: Ziftomenib with standard drugs during the first two phases, then a placebo.
- Group C: Placebo with standard drugs during all phases.
The study is "double-blind," meaning neither the patients nor the doctors know who is receiving Ziftomenib or a placebo.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Diagnosed with AML according to specific medical guidelines.
- Must be in good general health with a performance status score of 0, 1, or 2.
- Must have adequate liver and kidney function.
- Women of childbearing age must use effective birth control during the study and for 180 days after the last dose. Men must use birth control or abstain from sex during the study and for 90 days after the last dose.
Nonintensive Therapy Study (Ven+Aza):
- Must have a specific genetic mutation (NPM1-m).
- Must be ineligible for intensive therapy due to age (75 or older) or health issues.
Intensive Therapy Study (7+3):
- Must have specific genetic mutations (NPM1-m or KMT2A-r).
- Must not have certain other genetic mutations or be ineligible for specific targeted therapies.
- Must have a heart function of 50% or higher.
- Must be fit for intensive therapy according to the doctor's opinion.
Exclusion Criteria
- Have received prior therapy for AML, except for certain treatments to control white blood cell counts.
- Have a diagnosis of certain other types of leukemia or related conditions.
- Have a known history of specific genetic mutations not targeted by the study.
- Have other active cancers, except for certain skin cancers or cancers treated with curative intent.
- Have active central nervous system involvement by AML.
- Have high white blood cell counts before starting the study drug, unless controlled by specific treatments.
- Have uncontrolled HIV or active hepatitis B or C infections.
- Have other uncontrolled illnesses, including certain heart conditions.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Yale University School of Medicine | 06510 | New Haven | Connecticut |
| Wayne State University School of Medicine | 48201 | Detroit | Michigan |
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