Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06917911
PHASE2

Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II MYELOMATCH treatment trial compares the effect of venetoclax to gemtuzumab ozogamicin, when given with cytarabine and daunorubicin ("7+3" regimen), for the treatment of patients with core binding factor acute myeloid leukemia (CBF-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. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to an antitumor antibiotic drug, called ozogamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as cytarabine and daunorubicin 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 cytarabine and daunorubicin may have fewer side effects and be as effective or better than the combination with gemtuzumab ozogamicin in treating patients with core binding factor AML.

Official title: Phase II Study of Cytarabine + Daunorubicin (7 + 3) + Gemtuzumab Ozogamicin vs. Cytarabine + Daunorubicin (7 + 3) + Venetoclax for the Treatment of Newly Diagnosed Core Binding Factor Acute Myeloid Leukemia (CBF-AML) in Younger Adults: A MyeloMATCH Substudy

Key Details

Gender

All

Age Range

18 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

162

Start Date

2027-02-02

Completion Date

2027-11-25

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo optional buccal cell collection and/or blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Cytarabine

Given IV

DRUG

Daunorubicin Hydrochloride

Given IV

PROCEDURE

Echocardiography Test

Undergo echocardiography

DRUG

Gemtuzumab Ozogamicin

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

DRUG

Venetoclax

Given PO

Locations (23)

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

UofL Health Medical Center Northeast

Louisville, Kentucky, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, United States

Baptist Cancer Center-Grenada

Grenada, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, United States

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Community Medical Center

Missoula, Montana, United States

University of Rochester

Rochester, New York, United States

Baptist Memorial Hospital and Cancer Center-Collierville

Collierville, Tennessee, United States

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States