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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

NCT06504459 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Azacitidine

Given IV or SC

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

DRUG

Cladribine

Given IV

DRUG

Cytarabine

Given SC

PROCEDURE

Echocardiography

Undergo ECHO

PROCEDURE

Lumbar Puncture

Undergo LP

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Venetoclax

Given PO

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • AbbVie

    collaborator INDUSTRY

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Curtis A Lachowiez · OHSU Knight Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-03
Primary Completion
2027-10-11
Completion
2028-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06504459 on ClinicalTrials.gov