Venetoclax + Decitabine/Cedazuridine for Acute Myeloid Leukemia

Overseen by Abhishek Maiti, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies the effects of venetoxlax in combination with decitabine and cedazuridine in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). Chemotherapy drugs, such as venetoclax and 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. Cedazuridine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving venetoxlax in combination with decitabine and cedazuridine may help to control acute myeloid leukemia.

Research Team

Abhishek Maiti, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults (18+) with relapsed or refractory Acute Myeloid Leukemia, including biphenotypic leukemia with a myeloid component. Participants must have adequate organ function and performance status, agree to use effective contraception, and be able to consent. Excluded are those with severe conditions affecting drug absorption, uncontrolled illnesses, active hepatitis B/C or HIV, high white cell count without hydroxyurea treatment, pregnant or nursing women not using contraception, certain genetic abnormalities in their leukemia cells (t(15;17)), symptomatic CNS leukemia or active graft-versus-host disease.

Inclusion Criteria

I haven't had cancer treatment in the last 7 days, except for specific cases approved by my doctor.

Willing and able to provide informed consent

Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) < 3 x ULN unless considered due to leukemic involvement

Exclusion Criteria

I don't have severe stomach or metabolic issues affecting medication absorption.

My leukemia is of a specific type known as acute promyelocytic (M3-AML).

Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator

Treatment Details

Interventions

• Cedazuridine (Other)
• Decitabine (Anti-tumor antibiotic)
• Venetoclax (Other)

Trial Overview The trial is testing the combination of venetoclax with decitabine and cedazuridine for patients whose AML has returned after treatment or hasn't responded to other treatments. Venetoclax targets cancer cells' survival mechanisms while decitabine interferes with their DNA replication. Cedazuridine inhibits enzymes that could break down these drugs before they work.

Participant Groups

Group I: Treatment (decitabine and cedazuridine, venetoclax) Experimental Treatment 2 Interventions

Patients receive decitabine and cedazuridine PO QD on days 1-10. Patients who achieve CR/CRi during consolidation/maintenance may receive decitabine and cedazuridine PO QD on days 1-5. Patients also receive venetoclax PO QD on days 1-28 of cycle 1 and days 1-21 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine