Study on Venetoclax with Cladribine, Cytarabine, and Azacitidine for Newly Diagnosed Monocytic AML and Mutated AML

Sponsor: OHSU Knight Cancer Institute

Sponsor score: 60

ClinicalTrials ID:NCT06504459

Provider View

This clinical trial is testing a new treatment combination for patients with newly diagnosed monocytic acute myeloid leukemia (AML) and AML with specific mutations. The study aims to see if this combination can effectively kill cancer cells and improve patient outcomes.

Patient Parameters

Program Overview

This phase II study is exploring how well a combination of drugs—venetoclax, cladribine, cytarabine, and azacitidine—works in treating patients with newly diagnosed monocytic acute myeloid leukemia (AML) and AML with certain mutations. Venetoclax is a medication that may stop cancer cells from growing by blocking a protein they need to survive. The chemotherapy drugs cladribine, cytarabine, and azacitidine work in different ways to stop cancer cells from growing, dividing, or spreading. The study aims to find out if this combination can kill more cancer cells in these patients.

Description

The main goal of this study is to see how well the treatment works in achieving disease remission. Researchers will also look at how patients respond to the treatment, how long they survive without the disease getting worse, and how long the treatment effects last. The safety and side effects of the treatment will also be assessed.

The study involves several phases:

  • Induction Phase: Patients receive cladribine through an IV for 1-2 hours on days 1-5, cytarabine under the skin twice daily on days 1-10, and venetoclax by mouth daily on days 1-21 of the first cycle.

  • Re-Induction Phase: If patients still have more than 5% cancer cells after the first cycle, they receive another round of cladribine, cytarabine, and venetoclax.

  • Remission Phase: If patients achieve remission after the first cycle, they receive a shorter course of cladribine, cytarabine, and venetoclax.

  • Continuing Therapy: Patients who achieve a leukemia-free state continue with venetoclax and azacitidine for two cycles, then alternate with cladribine, cytarabine, and venetoclax for up to 18 cycles, as long as the disease does not progress and side effects are manageable.

Patients will undergo various tests, including heart scans, lumbar punctures, bone marrow biopsies, and blood tests throughout the study. After completing the treatment, patients will be followed up for two years.

Eligibility Criteria

Inclusion Criteria

  • Must understand the study and provide informed consent.
  • Patients of all races, ethnicities, and gender identities are eligible.
  • Newly diagnosed with monocytic AML or AML with specific mutations.
  • Cannot or do not want to undergo intensive chemotherapy.
  • If 75 years or older, must meet certain health criteria.
  • Willing to provide bone marrow samples and follow study requirements.
  • Negative pregnancy test for those of childbearing potential and agree to use contraception during the study.

Exclusion Criteria

  • Active central nervous system involvement with AML.
  • Previous treatment for AML, except for certain allowed medications.
  • Another active cancer within the last 5 years.
  • Recent major surgery or stem cell transplant.
  • Allergies to any study drugs.
  • Use of certain medications that interact with study drugs.
  • Uncontrolled infections or certain viral infections.
  • Pregnant or breastfeeding women.
  • Uncontrolled health conditions that could interfere with the study.

Locations

FACILITYZIPCITYSTATE
OHSU Knight Cancer Institute97239PortlandOregon

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