Study on Gilteritinib and Momelotinib for Patients with Relapsed or Hard-to-Treat FLT3-Mutated Acute Myeloid Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06235801

Provider View

This clinical trial is testing a combination of two drugs, gilteritinib and momelotinib, to find the best dose and see if they can help treat patients with a specific type of acute myeloid leukemia (AML) that has returned or is difficult to treat.

Patient Parameters

Program Overview

The purpose of this study is to determine the safest and most effective dose of momelotinib when used with gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML). The study will also evaluate how well this combination works in achieving remission and its overall safety.

Description

This study is divided into two phases. In Phase I, researchers aim to find the minimum safe and effective dose of momelotinib when combined with gilteritinib for patients with relapsed or refractory FLT3-mutated AML. In Phase II, the focus is on determining how well this drug combination works in achieving remission, including complete remission and other states of leukemia control.

Secondary goals include assessing other measures of effectiveness, such as the absence of measurable disease, survival rates, and the number of patients who can proceed to stem cell transplantation. The study will also evaluate the safety of the drug combination.

Exploratory objectives involve examining how genetic changes in the cancer affect treatment response and survival, understanding how the drugs are processed in the body, and studying changes in certain proteins and signaling pathways related to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML).
  • Must have a performance status score of 3 or lower, indicating the ability to carry out daily activities with some limitations.
  • Adequate liver and kidney function as shown by specific blood tests.
  • Willingness to use effective birth control methods during the study and for four months after.
  • Ability to understand and sign a written informed consent document.

Exclusion Criteria

  • Heart conditions that affect the heart's electrical activity, unless corrected or deemed not significant by a cardiologist.
  • Active serious infections not controlled by antibiotics.
  • Severe heart failure.
  • Active leukemia in the central nervous system.
  • Severe liver disease.
  • Positive for HIV or active hepatitis B or C infections, unless under control.
  • Recent treatment with other investigational or chemotherapy drugs, unless fully recovered from side effects or in life-threatening situations.
  • Inability to swallow pills.
  • Pregnant or breastfeeding women.
  • History of allergic reactions to similar drugs used in the study.
  • Psychiatric or social conditions that would prevent following study requirements.

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