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RECRUITING
NCT05010772
PHASE1

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

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Official title: Oral Decitabine-Based Maintenance Therapy in Patients With AML in Remission

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

125

Start Date

2021-10-25

Completion Date

2026-12-31

Last Updated

2026-01-14

Healthy Volunteers

No

Interventions

DRUG

Decitabine and Cedazuridine

Given PO

DRUG

Enasidenib

Given PO

DRUG

Gilteritinib

Given PO

DRUG

Ivosidenib

Given PO

DRUG

Venetoclax

Given PO

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States