RecruitingPhase 2NCT06504459

Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML

A Phase II Study of Venetoclax (ABT-199) in Combination With Cladribine and Low-Dose Cytarabine Alternating With Azacitidine Plus Venetoclax in Newly Diagnosed Monocytic AML and Active-Signaling Mutated AML


Sponsor

OHSU Knight Cancer Institute

Enrollment

40 participants

Start Date

Jan 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax works in treating patients with newly diagnosed monocytic acute myeloid leukemia (AML) and active signaling mutated AML. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cladribine, cytarabine and azacitidine, 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. Giving venetoclax with cladribine and cytarabine alternating with azacitidine and venetoclax may kill more cancer cells in patients with newly diagnosed monocytic AML and active signaling mutated AML.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of drugs — venetoclax, cladribine, cytarabine, and azacitidine — for patients with newly diagnosed acute myeloid leukemia (AML) who are not suitable for or do not want intensive chemotherapy. It focuses on certain subtypes including monocytic AML and AML with specific genetic mutations. **You may be eligible if...** - You have newly diagnosed AML with monocytic features or specific signaling mutations (such as KRAS, NRAS, FLT3, NF1) - You are not a candidate for intensive chemotherapy (e.g., due to age 75+, heart problems, poor performance status, or liver/kidney issues) - You are 18 or older - Your organ function meets study requirements **You may NOT be eligible if...** - You are suitable for and willing to undergo standard intensive chemotherapy - You have active, uncontrolled infections or other serious medical conditions - You are pregnant or breastfeeding - You have previously received treatment for AML 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 or SC

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDUREBone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

DRUGCladribine

Given IV

DRUGCytarabine

Given SC

PROCEDUREEchocardiography

Undergo ECHO

PROCEDURELumbar Puncture

Undergo LP

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

OTHERQuestionnaire Administration

Ancillary studies

DRUGVenetoclax

Given PO


Locations(2)

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

View Full Details on ClinicalTrials.gov

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NCT06504459


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