RecruitingPhase 1Phase 2NCT04797767

Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms

A Phase 1/2 Single-Center Trial Combining Venetoclax With G-CSF, Cladribine, Cytarabine, and Mitoxantrone (CLAG-M) for Patients With AML and High-Grade Myeloid Neoplasms


Sponsor

University of Washington

Enrollment

62 participants

Start Date

Feb 4, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II trial finds the best dose, side effects and how well giving venetoclax in combination with cladribine, cytarabine, granulocyte colony-stimulating factor, and mitoxantrone (CLAG-M) in treating patients with acute myeloid leukemia and high-grade myeloid neoplasms. Venetoclax 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 mitoxantrone, 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 CLAG-M may kill more cancer cells.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding venetoclax — a targeted drug that blocks a cancer cell survival protein — to a chemotherapy combination called CLAG-M can improve outcomes for people with acute myeloid leukemia (AML) or other high-grade blood cancers involving abnormal myeloid cells. The study covers both newly diagnosed high-risk patients and those whose disease has relapsed or is treatment-resistant. **You may be eligible if...** - You have a diagnosis of acute myeloid leukemia (AML) or a high-grade myeloid blood cancer (with 10% or more abnormal myeloid cells in blood or marrow) - For newly diagnosed: your disease is classified as high-risk (adverse risk AML) - For relapsed/refractory disease: your AML has come back or stopped responding to prior treatment - Mixed phenotype or biphenotypic acute leukemia is also eligible **You may NOT be eligible if...** - Your disease does not meet the required diagnostic criteria - Your overall health does not allow for intensive chemotherapy - You have had specific prior treatments that exclude you from this study 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCladribine

Given IV

DRUGCytarabine

Given IV

DRUGMitoxantrone

Given IV

BIOLOGICALRecombinant Granulocyte Colony-Stimulating Factor

Given subcutaneously

DRUGVenetoclax

Given PO

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04797767


Related Trials