OncoMatch/Clinical Trials/NCT06235801
A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
Is NCT06235801 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including Gilteritinib and Momelotinib for myeloid leukemia.
Treatment: Gilteritinib · Momelotinib — To learn the recommended dose of momelotinib that can be given in combination with gilteritinib to participants with AML.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: FLT3 d835
Required: FLT3 d836
Required: FLT3 itd
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: antileukemic therapy
relapsed/refractory FLT3-mutated AML
Cannot have received: investigational antileukemic agents or chemotherapy agents
Exception: unless full recovery from side effects has occurred or participant has rapidly progressive disease judged to be life-threatening by the investigator; prior recent treatment with corticosteroids, hydroxyurea and/or cytarabine (given for cytoreduction) permitted
Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry
Lab requirements
Kidney function
Creatinine clearance ≥ 30 mL/min
Liver function
Total serum bilirubin ≤ 2 x ULN, unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI; ALT or AST ≤ 3 x ULN, unless due to the underlying leukemia approved by the PI
Adequate liver and renal function as defined by the following criteria: Total serum bilirubin ≤ 2 x ULN, unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI; ALT or AST ≤ 3 x ULN, unless due to the underlying leukemia approved by the PI; Creatinine clearance ≥ 30 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06235801 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational antileukemic agents or chemotherapy agents disqualifies patients from enrollment.
Does this trial require FLT3?
Yes, FLT3 d835 is a required biomarker for enrollment.
Does this trial require FLT3?
Yes, FLT3 d836 is a required biomarker for enrollment.
Does this trial require FLT3?
Yes, FLT3 itd is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages