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NCT07007312 · ClinicalTrials.gov registry record · Phase 3
Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML
A Phase 3 study of Acute Myeloid Leukemia (AML), sponsored by Kura Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,300
- Enrollment target
- 20
- Study locations
NCT07007312 is a Phase 3 study of Acute Myeloid Leukemia (AML) that is actively recruiting participants, run by Kura Oncology. The registered enrollment target is 1,300 participants, above the 101-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (1187% higher). The trial reports 20 study locations across 16 states.
The verdict
NCT07007312, a Phase 3 study of Acute Myeloid Leukemia (AML), is actively recruiting participants, sponsored by Kura Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,300 participants
- Enrollment target
- 20
- Study locations
Study Summary
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".
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Placebo
- DRUG Daunorubicin
- DRUG Azacitidine (AZA)
- DRUG Ziftomenib
Study Locations (20)
California
- University of California, San Diego - La Jolla
- Cedars-Sinai Medical Center - Los Angeles
- University of California, Irvine - Orange
Florida
- University of Miami - Miami
- Moffitt Cancer Center & Research Institute - Tampa
North Carolina
- University of North Carolina, Chapel Hill - Chapel Hill
- Duke University Medical Center - Durham
Arizona
- Banner MD Anderson Cancer Center - Gilbert
Colorado
- Colorado Blood Cancer Institute - Denver
Connecticut
- Yale University School of Medicine - New Haven
Kentucky
- University of Kentucky - Lexington
Michigan
- Wayne State University School of Medicine - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,300 participants |
| Start Date | 2025-09-26 |
| Est. Completion | 2031-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07007312
The ClinicalTrials.gov registry entry for NCT07007312 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 101-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (1187% higher). The listed sponsor is Kura Oncology, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.
NCT07007312 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT07007312 about?
NCT07007312 is a clinical study titled "Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML". 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 b...
What is the current status of trial NCT07007312?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,300 participants. The study started on 2025-09-26. Estimated completion is 2031-11.
What conditions does trial NCT07007312 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML).
What interventions are being tested in trial NCT07007312?
The interventions under investigation include: Venetoclax (DRUG), Placebo (DRUG), Daunorubicin (DRUG), Azacitidine (AZA) (DRUG), Ziftomenib (DRUG).
Who is sponsoring clinical trial NCT07007312?
This trial is sponsored by Kura Oncology, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07007312 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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