Actively Recruiting
A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-06-08
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of momelotinib and gilteritinib in adults with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML). The study aims to find the recommended dose of momelotinib that can be safely given with gilteritinib and to determine the treatment's effectiveness in inducing remission. This phase I/II trial also explores safety, survival outcomes, and how genetic factors may influence response to treatment. Participants receive momelotinib and gilteritinib as oral medications. In Part 1, momelotinib doses vary to find the safest effective amount, while in Part 2, participants receive the recommended dose found earlier. Gilteritinib is given at a fixed dose to all. The first treatment cycle lasts 35 days, with momelotinib given daily from days 1 to 35 and gilteritinib from days 8 to 35. Subsequent cycles last 28 days, with both drugs taken daily throughout. During the study, participants will be closely monitored for safety and side effects for about one year. Researchers will assess treatment responses through various tests, including bone marrow evaluations and genetic analyses. Participants' health status, medication effects, and potential side effects will be regularly checked to understand the treatment's impact and to support participant safety throughout the trial.
CONDITIONS
Brief Title
A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with relapsed or refractory FLT3-mutated AML
- FLT3-ITD or FLT3 D835/D836 mutations
- Performance status 3 or less on the ECOG scale
- Adequate liver function: total serum bilirubin ≤ 2 times upper limit of normal (ULN) unless approved
- Adequate liver enzymes: ALT or AST ≤ 3 times ULN unless approved
- Creatinine clearance ≥ 30 mL/min
- Willingness to use effective contraception during and for 4 months after study participation
- Ability and willingness to sign informed consent
You will not qualify if you...
- Congenital long QT syndrome or QTcF > 450 msec unless approved by cardiologist
- Active serious infection not controlled by antibiotics
- Active Class III-V heart failure
- Active central nervous system leukemia
- Child-Turcotte-Pugh class C cirrhosis
- Known HIV positive status
- Known hepatitis B or active hepatitis C infection without undetectable viral load
- Prior or concurrent malignancy interfering with study assessments unless approved
- Treatment with investigational antileukemic or chemotherapy agents in last 7 days unless recovered or rapidly progressing disease
- Inability to swallow medications
- Unable or unwilling to sign informed consent
- Pregnant or breastfeeding women; must be nonpregnant and using effective contraception if of childbearing potential
- Psychiatric illness or social situations limiting study compliance
- History of allergic reactions to gilteritinib, momelotinib, or similar agents
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 - Repeated 28-day cycles until disease progression or discontinuation
Participants receive momelotinib and gilteritinib orally in treatment cycles. Cycle 1 lasts 35 days with momelotinib given daily on days 1-35 and gilteritinib given daily on days 8-35. Subsequent cycles last 28 days with both drugs given daily on days 1-28.
Visits occur at the start of each cycle and as needed for safety monitoring
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nicholas Short, MD
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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