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Tyrosine Kinase Inhibitor

Gilteritinib + Momelotinib for Acute Myeloid Leukemia

Phase 1 & 2
Recruiting
Led By Nicholas Short, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
a) Adults ≥18 years with relapsed/refractory FLT3-mutated AML. Participants with either FLT3-ITD or FLT3 D835/D836 mutations will be eligible
Performance status ≤3 (ECOG Scale)
Must not have
Known human immunodeficiency virus (HIV) seropositive
Congenital long QT syndrome or QTcF >450 msec
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights

Summary

This trial aims to determine the safe and effective dose of momelotinib that can be given alongside gilteritinib to individuals with acute myeloid leukemia (AML).

Who is the study for?
Adults over 18 with relapsed or refractory FLT3-mutated Acute Myeloid Leukemia (AML) can join this trial. They should be relatively stable (ECOG ≤3), have acceptable liver function tests, and a creatinine clearance of ≥30 mL/min. Participants must agree to use effective contraception during the study and for four months after.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs, Momelotinib and Gilteritinib, to find out the safest dose that works for AML patients who have specific genetic changes in their leukemia cells.See study design
What are the potential side effects?
Potential side effects may include but are not limited to fatigue, gastrointestinal issues like nausea or diarrhea, liver enzyme elevations, skin reactions, blood count abnormalities which could increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am an adult with AML that has come back or didn't respond to treatment, and my AML has a specific FLT3 mutation.
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I can take care of myself but might not be able to do any work.
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I can care for myself but cannot do any physical work.
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I am an adult with AML that has come back or didn't respond to treatment, and it has a FLT3 mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV positive.
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I have a long QT syndrome or my QTcF is over 450 msec.
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I have a serious infection that isn't getting better with antibiotics.
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My liver disease is severe.
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I do not have severe heart failure.
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I have leukemia that has spread to my brain or spinal cord.
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I cannot swallow.
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I cannot or do not want to sign the consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and adverse events (AEs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose Escalation Phase 1/Phase 2Experimental Treatment2 Interventions
Participants who are enrolled in Part 1, the dose of momelotinib you receive will depend on when you join this study. Participants you are enrolled in Part 2, you will receive momelotinib at the recommended dose that was found in Part 1. All participants will receive the same dose level of gilteritinib. Cycle 1 will be 35 days in length. Momelotinib will be administered once daily by mouth on days 1-35. Gilteritinib will be administered once daily by mouth on days 8-35. Cycles 2 and beyond will be 28 days in length. Momelotinib and gilteritinib will be administered once daily by mouth on days 1-28.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gilteritinib
2014
Completed Phase 2
~560
Momelotinib
2013
Completed Phase 3
~1060

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,259 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,772 Previous Clinical Trials
8,106,883 Total Patients Enrolled
Nicholas Short, MDPrincipal InvestigatorMD Anderson Center
6 Previous Clinical Trials
374 Total Patients Enrolled
~13 spots leftby Oct 2027
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