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

RECRUITINGPHASE1/PHASE2

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

NCT06235801•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

To learn the recommended dose of momelotinib that can be given in combination with gilteritinib to participants with AML.

Detailed Description

Primary Objectives * Phase I: To establish the minimum safe and biologically-effective dose of momelotinib in combination with gilteritinib in relapsed/refractory FLT3-mutated AML * Phase II: To determine the modified CRc rate of the regimen, including complete remission (CR), CR with incomplete hematologic recovery (CRi) or morphologic leukemia free state (MLFS) Secondary Objectives * To assess other efficacy endpoints (CR rate, measurable residual disease negativity by flow cytometry and FLT3 PCR, relapse-free survival, overall survival) * To assess proportion of participants proceeding to allogeneic hematopoietic stem cell transplantation * To determine the safety of the combination regimen Exploratory Objectives * To evaluate the impact of baseline genomic alterations on response and survival of the combination regimen * To determine the impact of baseline FLT3 allelic ratio on response and survival * To evaluate the pharmacokinetics (e.g. AUC, Cmax, Tmax and half-life) of momelotinib in the combination regimen * To evaluate changes in circulating cytokine levels in response to treatment * To evaluate inhibition of FLT3 signaling and inhibition of JAK/STAT signaling pathways * To evaluate other biomarkers associated with response and resistance to the combination regimen

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis:
•a) Adults ≥18 years with relapsed/refractory FLT3-mutated AML. Participants with either FLT3-ITD or FLT3 D835/D836 mutations will be eligible
•2. Performance status ≤3 (ECOG Scale).
•3. Adequate liver and renal function as defined by the following criteria:
•1. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI
•2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3 x ULN, unless due to the underlying leukemia approved by the PI
•d) Creatinine clearance ≥ 30 mL/min
•4. Willingness to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study participation. For women of childbearing potential, adequate methods of contraception include: complete abstinence, hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal Ligation or hysterectomy, participants/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide
•5. Ability to understand and the willingness to sign a written informed consent document.
•2. Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment).
+13 more criteria

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

May 22, 2024

Primary Completion Date

October 1, 2027

Completion Date

October 1, 2029

Last Updated

November 19, 2025

Enrollment

ESTIMATED participants

Conditions

Myeloid Leukemia

Interventions

Gilteritinib

DRUG

Momelotinib

DRUG

Contacts

Nicholas Short, MD

CONTACT

(713) 563-4485 nshort@mdanderson.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

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