Actively Recruiting
A Phase I Study Investigating the Combination of the Ziftomenib, Venetoclax and Azacitidine in Pediatric Relapsed and Refractory Acute Leukemias
Led by M.D. Anderson Cancer Center · Updated on 2026-01-29
22
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
K
Kura Oncology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To find the highest safe dose of ziftomenib that can be combined with venetoclax and azacitidine in pediatric participants with acute leukemia that has certain types of genetic mutations (changes).
CONDITIONS
Official Title
A Phase I Study Investigating the Combination of the Ziftomenib, Venetoclax and Azacitidine in Pediatric Relapsed and Refractory Acute Leukemias
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 to 21 years
- ECOG performance status of 2 or less
- Diagnosed with relapsed or refractory acute leukemia including AML, MPAL, ALL, or ALAL with KMT2A-r, NPM1-m, NUP98-r, or HOX pathway mutations
- At least 5% leukemic blasts in bone marrow
- White blood cell count below 25,000 per microliter at enrollment (cytoreduction allowed before enrollment)
- Baseline heart ejection fraction greater than 40%
- Adequate liver function with bilirubin and liver enzymes within specified limits
- Adequate kidney function with creatinine clearance at least 30 mL/min unless related to disease
- At least 14 days from prior treatment or 5 half-lives of prior therapy unless rapidly proliferative disease
- Women of childbearing potential and males must agree to contraception during study and specified months after last treatment unless sterile
You will not qualify if you...
- Weighing less than 10 kilograms
- Having uncontrolled medical conditions, laboratory abnormalities, or psychiatric illnesses posing unacceptable risk
- Using other chemotherapy or anti-leukemic agents except specified exceptions
- Having severe gastrointestinal or metabolic conditions interfering with oral medication absorption
- Having concurrent active malignancy under treatment
- Known active hepatitis B or C infection, uncontrolled HIV/AIDS, or taking contraindicated HIV medications
- Pregnant or breastfeeding females
- Active uncontrolled infections
- Recent (within 6 months) serious heart conditions including heart attack, unstable angina, heart failure, severe arrhythmia, stroke, or transient ischemic attack
- Corrected QT interval over 480 ms on ECG
- Any condition or therapy that might interfere with study results or full participation
- Clinically active central nervous system leukemia
- Grade higher than 2 active acute graft-versus-host disease or moderate/severe chronic graft-versus-host disease
- Consumption of grapefruit, Seville oranges, or star fruit within 3 days before first venetoclax dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
David McCall, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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