RecruitingPhase 1NCT05010772

Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission

Oral Decitabine-Based Maintenance Therapy in Patients With AML in Remission

Sponsor

M.D. Anderson Cancer Center

Enrollment

125 participants

Start Date

Oct 25, 2021

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

Summary

This phase Ib trial is to find out the side effects and possible benefits of decitabine alone or given together with venetoclax, gilteritinib, enasidenib, or ivosidenib in treating patients with acute myeloid leukemia that is under control (remission). Chemotherapy drugs, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2 needed for cell growth. Gilteritinib, enasidenib, and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine alone or together with venetoclax, gilteritinib, enasidenib, or ivosidenib may help to control the disease.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests maintenance therapies for adults with acute myeloid leukemia (AML) — a blood cancer — who have achieved remission but are not yet candidates for a bone marrow transplant. The goal is to keep the cancer in remission longer using drugs like decitabine, venetoclax, gilteritinib, enasidenib, or ivosidenib. **You may be eligible if...** - You are 18 or older with AML that is currently in complete remission (first remission) - You are not currently eligible for a bone marrow (stem cell) transplant - You received standard intensive chemotherapy to achieve remission and completed at least one consolidation cycle - Your blood counts, organ function, and overall health meet certain thresholds - You have no active infections or other major medical issues **You may NOT be eligible if...** - You have never achieved remission - You are immediately eligible for and planning a stem cell transplant - You have active uncontrolled infection or other serious health conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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