Actively Recruiting
Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for Treating Relapsed/Refractory Acute Myeloid Leukemia with KMT2A Rearrangement or NPM1 Mutation
Led by Kura Oncology, Inc. · Updated on 2026-04-14
171
Participants Needed
45
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and antileukemic response of the drug ziftomenib when combined with standard treatments for patients with relapsed or refractory acute myeloid leukemia (AML). This Phase 1 study focuses on participants who have specific genetic mutations, including NPM1 mutation or KMT2A rearrangement, and aims to find safe and tolerable dosing levels for these combinations. The study includes oral ziftomenib combined with other treatments such as FLAG-IDA (a regimen including fludarabine, cytarabine, idarubicin, and granulocyte colony-stimulating factor), low-dose cytarabine, or gilteritinib. Participants are enrolled in different groups based on their genetic mutation and treatment combination, with dose escalation cohorts to identify maximum tolerated doses followed by dose validation and expansion cohorts. Participants will be monitored closely during the treatment cycles, which typically last 28 days, with assessments of dose-limiting toxicities and adverse events. Researchers will measure remission rates, survival outcomes, and drug levels in the body up to 12 months after treatment ends. Participants will also undergo evaluations of heart function, liver and kidney health, and overall condition to ensure safety throughout the study.
CONDITIONS
Brief Title
Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with relapsed or refractory acute myeloid leukemia (AML)
- Documented NPM1 mutation or KMT2A rearrangement
- For cohort A-3, a documented FLT3 mutation is required
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate liver and kidney function as defined in the study protocol
- Ejection fraction above the study's defined limit
- Able to understand and provide written informed consent
- Agreed to use contraception as defined in the protocol
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia
- Clinically active central nervous system leukemia
- Active and uncontrolled infection
- Mean corrected QT interval (QTcF) greater than 480 ms
- Uncontrolled intercurrent illness, including specific cardiac diseases
- Received radiation, chemotherapy, immunotherapy, or other anticancer therapy within 14 days or within 5 drug half-lives before starting study treatment
- Major surgery within 4 weeks before starting study treatment
- Received hematopoietic stem cell transplant (HSCT) without adequate recovery
- Active graft-versus-host disease or on immunosuppressive drugs for its treatment
- Pregnant or lactating
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - First 28 days of ziftomenib in combination with standard of care treatment (1 cycle)
Participants receive oral ziftomenib in combination with other drugs depending on their assigned cohort to determine safety and tolerability.
Weekly visits for up to 4 weeks
Duration - Up to 12 months following discontinuation of treatment
Participants are monitored for up to 12 months after discontinuing treatment to assess remission rates, survival, and other long-term outcomes.
Regular visits for up to 12 months
Trial Site Locations
Total: 45 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089
Actively Recruiting
3
UCLA Health - Bowyer Oncology Center
Los Angeles, California, United States, 90095
Actively Recruiting
4
UC Irvine Health Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
5
University of California San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
6
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
7
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06511
Actively Recruiting
8
Emory Healthcare - The Emory Clinic
Atlanta, Georgia, United States, 30322
Actively Recruiting
9
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
10
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
11
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
12
Simmons Cancer Institute
Springfield, Illinois, United States, 62702
Withdrawn
13
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
14
The University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
15
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
16
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
17
Henry Ford Cancer Institute
Detroit, Michigan, United States, 48202
Actively Recruiting
18
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
19
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
20
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
21
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
22
Northwell Health, LLC PRIME
Lake Success, New York, United States, 11042
Actively Recruiting
23
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
24
Weill Cornell Medical College-NY Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
25
Wilmot Cancer Institute, University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
26
Stony Brook Cancer Center
Stony Brook, New York, United States, 11794
Actively Recruiting
27
Atrium Health Levine Cancer Center
Charlotte, North Carolina, United States, 60201
Actively Recruiting
28
UH Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
29
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
30
Lehigh Valley Topper Cancer Institute
Allentown, Pennsylvania, United States, 18103
Withdrawn
31
Prisma Health
Greenville, South Carolina, United States, 29615
Actively Recruiting
32
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
33
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
34
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
35
University of Vermont
Burlington, Vermont, United States, 05401
Actively Recruiting
36
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
37
University of Washington
Seattle, Washington, United States, 98109
Actively Recruiting
38
Froedtert & Medical College Clinics
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
39
IRCCS Azienda Ospedaliero-Universitaria do Bologna - Policlinico di Sant'Orsola
Bologna, Italy, 40138
Actively Recruiting
40
Ospedale Santa Maria delle Croci
Ravenna, Italy, 48121
Actively Recruiting
41
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
42
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
43
Hospital Universitario Central de Asturias
Oviedo, Spain, 33011
Actively Recruiting
44
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
45
Hospital Universitari y Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
Research Team
K
Kura Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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