Actively Recruiting
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
Led by M.D. Anderson Cancer Center · Updated on 2026-01-12
73
Participants Needed
1
Research Sites
478 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I/II trial studies how well quizartinib, decitabine, and venetoclax work in treating participants with acute myeloid leukemia or high risk myelodysplastic syndrome that is untreated or has come back (relapsed). Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving quizartinib and decitabine may work better at treating acute myeloid leukemia and myelodysplastic syndrome.
CONDITIONS
Official Title
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of AML with at least 20% blasts or MDS with more than 10% blasts
- For frontline patients: Age 60 or older and not candidates for intensive chemotherapy
- Not candidates for intensive remission induction chemotherapy due to age 75 or older, or under 75 with poor performance or significant heart/lung conditions
- Newly diagnosed AML patients 60 years or younger with poor risk complex karyotype and/or TP53 mutations
- For relapsed patients: Age 18 or older, not eligible for curative therapy or who refuse such therapy
- FLT3-ITD mutation or FLT3-ITD/TKD co-mutations detected within 30 days prior to enrollment
- Frontline patients must be chemotherapy-naive except limited prior treatments for control
- Relapsed patients may have received up to 4 prior salvage therapies
- At least 2 weeks interval from prior cytotoxic treatment or 5 half-lives for other agents
- No chemotherapy during study except certain allowed agents
- ECOG performance status 0 or 1
- Acceptable kidney and liver function within specified limits
- White blood cell count less than 25 x 10^9/L
- Normal potassium, magnesium, and calcium levels
- Able to take oral medication
- Able to understand and sign informed consent
- Baseline left ventricular ejection fraction at least 50%
- Women of childbearing potential must have negative pregnancy test and use contraception
- Men must agree to use contraception if partner is of childbearing potential
- Use of investigational agents allowed if not leukemia treatment per se
You will not qualify if you...
- Allergy or hypersensitivity to quizartinib, mannitol, decitabine, or components
- Prior use of quizartinib
- Uncontrolled central nervous system leukemia
- Frontline patients fit for intensive chemotherapy
- Electrolyte abnormalities despite supplementation
- Significant gastrointestinal conditions affecting drug absorption
- Severe uncontrolled medical conditions or active infections
- Concurrent antineoplastic or radiation therapy for other cancers (except maintenance/hormonal/steroid therapy)
- Known HIV infection
- Positive hepatitis B or C infection without undetectable viral load
- Recent consumption of grapefruit, Seville oranges, or starfruit within 3 days
- Major surgery within 14 days before treatment
- Impaired cardiac function including prolonged QTc interval, congenital long QT syndrome, recent heart attack, heart failure class III/IV, recent atrial fibrillation, or certain conduction abnormalities
- Use of strong CYP3A4 inducers or inhibitors except standard antibiotics/antifungals/antivirals
- Family history of congenital long QT syndrome
- On strong CYP3A4 inhibitors not allowed by protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Musa Yilmaz
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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