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Tyrosine Kinase Inhibitor

Dose Escalation Phase 1/Phase 2 for Myeloid Leukemia

Phase 1 & 2

Waitlist Available

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study 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.

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

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,971 Previous Clinical Trials

1,787,196 Total Patients Enrolled

GlaxoSmithKlineIndustry Sponsor

4,751 Previous Clinical Trials

8,067,452 Total Patients Enrolled

Nicholas Short, MDPrincipal InvestigatorMD Anderson Center

5 Previous Clinical Trials

344 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently able to enroll in this ongoing medical study?

"As stated on clinicaltrials.gov, this specific trial is not currently actively seeking participants. The initial posting of the study occurred on July 31st, 2024, and it was last updated on January 23rd, 2024. However, there are presently a total of 1443 other trials that are enrolling patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia

2024. "A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06235801.