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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 (May 2026). This Phase 1/2 trial studies multiple treatments including Gilteritinib and Momelotinib for myeloid leukemia.

Phase 1/2RecruitingM.D. Anderson Cancer CenterNCT06235801Data as of May 2026

Treatment: Gilteritinib · MomelotinibTo learn the recommended dose of momelotinib that can be given in combination with gilteritinib to participants with AML.

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Extracted eligibility criteria

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

Min 1 prior line

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 →

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