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ACTIVE NOT RECRUITING
NCT04746235
PHASE2

Venetoclax and ASTX727 for the Treatment of Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

This phase II trial studies the possible benefits of venetoclax and ASTX727 in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory), or elderly patients with newly diagnosed acute myeloid leukemia who are not candidates for intensive chemotherapy. Venetoclax may help block the formation of growths that may become cancer. 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. Giving venetoclax and ASTX727 may help to control the disease.

Official title: A Phase 2 Study of Venetoclax in Combination With ASTX727 in Patients With Relapsed/Refractory Acute Myeloid Leukemia, and Newly Diagnosed Elderly Patients With AML Who Are Not Candidates for Intensive Chemotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

85

Start Date

2021-02-22

Completion Date

2026-10-31

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DRUG

Decitabine and Cedazuridine

Given PO

DRUG

Venetoclax

Given PO

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States