Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

Description

A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin \[GO\]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.

Conditions

Acute Myeloid Leukemia

Study Overview

Study Details

Study overview

A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin \[GO\]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.

A Randomized Phase 3 Trial of Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML

Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

Condition
Acute Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202

Long Beach

MemorialCare Miller Children's and Women's Hospital Long Beach, Long Beach, California, United States, 90806

Orange

Children's Hospital of Orange County Main Campus - Orange, Orange, California, United States, 92868

San Francisco

Benioff Children's Hospital - Mission Bay, San Francisco, California, United States, 94158

Aurora

Children's Hospital Colorado, Aurora, Colorado, United States, 80045

New Haven

Yale University, New Haven, Connecticut, United States, 06511

Wilmington

Nemours Alfred I. Dupont Hospital for Children, Wilmington, Delaware, United States, 19803

Fort Myers

Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States, 33908

Jacksonville

Nemours Children's Specialty Care Jacksonville, Jacksonville, Florida, United States, 32207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    29 Days to 21 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    LLS PedAL Initiative, LLC,

    Seth Karol, MD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

    Marlous Bakker, STUDY_DIRECTOR, Princess Maxima Center for Pediatric Oncology

    Study Record Dates

    2032-02