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RecruitingPhase 1Phase 2NCT04774393

Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Phase 1b/2 Study of Oral Decitabine/Cedazuridine (ASTX727) and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Ivosidenib or the Targeted Mutant IDH2 Inhibitor Enasidenib

Sponsor

M.D. Anderson Cancer Center

Enrollment

84 participants

Start Date

May 24, 2021

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid LeukemiaRecurrent Acute Myeloid LeukemiaRefractory Acute Myeloid Leukemia

Summary

This phase Ib/II trials studies the side effects of decitabine/cedazuridine (ASTX727) and venetoclax in combination with ivosidenib or enasidenib, and how well they work in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). ASTX727 is the combination of a fixed dose of 2 drugs, cedazuridine and decitabine. Cedazuridine may slow down how fast decitabine is broken down by the body, and decitabine may block abnormal cells or cancer cells from growing. Venetoclax may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Enasidenib and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine/cedazuridine and venetoclax in combination with ivosidenib or enasidenib may help control acute myeloid leukemia.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of drugs for people with acute myeloid leukemia (AML — a fast-growing blood cancer) whose cancer has returned or stopped responding to treatment. The combination includes a DNA-targeting drug (decitabine/cedazuridine), venetoclax (which blocks a survival protein in cancer cells), and either ivosidenib or enasidenib (targeted drugs for specific AML mutations). **You may be eligible if...** - You have AML that has come back or is not responding to treatment, OR - You are newly diagnosed with AML, are over 60, and are not fit enough for intensive chemotherapy - You have adequate kidney and liver function **You may NOT be eligible if...** - You have acute promyelocytic leukemia (a specific AML subtype treated differently) - You have very poor organ function - You have certain other active cancers - 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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Interventions

DRUGDecitabine and Cedazuridine

Given PO

DRUGEnasidenib

Given PO

DRUGIvosidenib

Given PO

DRUGVenetoclax

Given PO

Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04774393

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