RecruitingPhase 2NCT04905810

Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure

Phase II Study of Venetoclax With Alternative Hypomethylating Agent for Patients With Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure: A University of California Hematologic Malignancies Consortium Protocol


Sponsor

Brian Jonas

Enrollment

20 participants

Start Date

Feb 9, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial evaluates the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before (treatment naive) or has come back (relapsed). Chemotherapy drugs, such as azacitidine, decitabine, and venetoclax, 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the combination of azacitidine or decitabine (hypomethylating agents) with venetoclax in patients with acute myeloid leukemia (AML) who previously received hypomethylating agent therapy for a blood disorder like myelodysplastic syndrome (MDS) and then progressed to AML. **You may be eligible if...** - You are 18 or older and have been diagnosed with AML - You are not eligible for intensive chemotherapy (due to age 75+, or a serious health condition like heart, lung, liver, or kidney problems) - You previously received a hypomethylating agent for a pre-existing blood disorder that has now progressed to AML **You may NOT be eligible if...** - You have received prior treatment for AML itself (not the pre-existing blood disorder) - Your kidney, liver, or heart function is too impaired to safely receive these drugs - You have active serious infections - 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

DRUGAzacitidine

Given IV

DRUGDecitabine

Given IV

DRUGVenetoclax

Given PO


Locations(4)

UCSF-Fresno

Clovis, California, United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

View Full Details on ClinicalTrials.gov

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NCT04905810


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