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Tyrosine Kinase Inhibitor

Gilteritinib + Momelotinib for Acute Myeloid Leukemia

Houston, TX

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

No Placebo-Only Group

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).

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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.

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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.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~660

Momelotinib

2013

Completed Phase 3

~1060