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 2025-11-19
20
Participants Needed
1
Research Sites
279 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
To learn the recommended dose of momelotinib that can be given in combination with gilteritinib to participants with AML.
CONDITIONS
Official 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 acute myeloid leukemia (including FLT3-ITD or FLT3 D835/D836 mutations)
- Performance status of 3 or less on the ECOG scale
- Adequate liver function with total serum bilirubin 2 times or less the upper limit of normal unless approved by the investigator
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels 3 times or less the upper limit of normal unless approved by the investigator
- Creatinine clearance of 30 mL/min or higher
- Willingness to use adequate contraception during the study and for 4 months after
- Ability to understand and sign informed consent
You will not qualify if you...
- Congenital long QT syndrome or QTcF greater than 450 msec unless manually confirmed to be 450 msec or less
- 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 surface antigen positive or active hepatitis C infection without undetectable viral load
- Prior or concurrent malignancy that may interfere with the study unless approved by the investigator
- Treatment with investigational antileukemic or chemotherapy agents within 7 days before study entry unless fully recovered or rapidly progressive disease
- Inability to swallow medication
- Unable or unwilling to sign informed consent
- Pregnant or breastfeeding women
- Participants with psychiatric or social conditions limiting study compliance
- History of allergic reactions to gilteritinib, momelotinib, or related compounds
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
N
Nicholas Short, 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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