RecruitingPhase 3NCT05183035

Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

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

Sponsor

PedAL BCU, LLC

Enrollment

130 participants

Start Date

Oct 1, 2022

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

Summary

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.

Eligibility

Min Age: 29 DaysMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether venetoclax — a drug that helps cancer cells die — combined with standard chemotherapy can help children, teenagers, and young adults with acute myeloid leukemia (AML, a type of blood cancer) that has come back or is hard to treat. **You may be eligible if:** - You are between 29 days and 21 years old - You have been diagnosed with AML that does not have the FLT3-ITD genetic mutation - Your AML is either at first relapse and you cannot tolerate more anthracycline chemotherapy, or at second relapse and you are fit enough for more intensive chemotherapy - You are in reasonably good health (Lansky or Karnofsky score 50% or above) - You have recovered from the side effects of your last cancer treatment **You may NOT be eligible if:** - Your AML has the FLT3-ITD mutation - You have not yet recovered from prior chemotherapy - You are not enrolled in the required screening study (for participants in USA, Canada, Australia, or New Zealand) 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

DRUGFludarabine

Intravenous (IV) infusion

DRUGCytarabine

Intravenous (IV) infusion

DRUGGemtuzumab Ozogamicin

Intravenous (IV) infusion

DRUGAzacitidine

Intravenous (IV) infusion or subcutaneous injection

DRUGVenetoclax

Orally via tablet or powder suspension

Locations(89)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

MemorialCare Miller Children's and Women's Hospital Long Beach

Long Beach, California, United States

Children's Hospital of Orange County Main Campus - Orange

Orange, California, United States

Benioff Children's Hospital - Mission Bay

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

Nemours Alfred I. Dupont Hospital for Children

Wilmington, Delaware, United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

University of Florida Health Shands Children's Hospital

Gainesville, Florida, United States

Nemours Children's Specialty Care Jacksonville

Jacksonville, Florida, United States

Nemours Children's Hospital - Orlando

Orlando, Florida, United States

Saint Joseph's Hospital - Tampa

Tampa, Florida, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Kapi'olani Medical Center for Women and Children

Honolulu, Hawaii, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Comer Children's Hospital

Chicago, Illinois, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

University of Iowa Stead Family Children's Hospital

Iowa City, Iowa, United States

Norton Children's Hospital

Louisville, Kentucky, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

Masonic Cancer Center

Minneapolis, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

The Children's Mercy Hospital - Adele Hall Campus

Kansas City, Missouri, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Alliance for Childhood Diseases dba Cure 4 The Kids Foundation

Las Vegas, Nevada, United States

Hackensack University Medical Center, HMH

Hackensack, New Jersey, United States

Morristown Medical Center

Morristown, New Jersey, United States

Columbia University Irving Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center - New York

New York, New York, United States

Cohen Children's Medical Center

Queens, New York, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Doernbecher Children's Hospital

Portland, Oregon, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Prisma Health Richland Hospital

Columbia, South Carolina, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Harold C. Simmons Comprehensive Cancer Center

Dallas, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Children's Hospital of Richmond at Virginia Commonwealth University

Richmond, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

Children's Health Queensland Hospital and Health Service

South Brisbane, Queensland, Australia

The Royal Children's Hospital - Children's Cancer Centre

Parkville, Victoria, Australia

Perth Children's Hospital

Nedlands, Western Australia, Australia

Sankt Anna-Kinderspital

Vienna, Austria

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, Belgium

Alberta Children's Hospital

Calgary, Alberta, Canada

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Izaak Walton Killam (IWK) Health Center

Halifax, Nova Scotia, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

SickKids - The Hospital for Sick Children

Toronto, Ontario, Canada

Fakultni nemocnice v Motole

Prague, Prague, Czechia

Rigshospitalet

Copenhagen, Capital Region, Denmark

Uusi Lastensairaala

Helsinki, Etelä-Suomen Lääni, Finland

CHU de Toulouse - Hôpital des Enfants

Toulouse, Haute-Garonne, France

Hôpital Jeanne de Flandre

Loos, Hauts-de-France, France

CHU de Nantes - Hôpital Femme-Enfant-Adolescent

Nantes, Loire-Atlantique, France

Institut d'Hématologie et d'Oncologie Pédiatrique

Lyon, Rhône, France

Hôpital Armand-Trousseau

Paris, Île-de-France Region, France

Hôpital Universitaire Robert-Debré

Paris, Île-de-France Region, France

Universitätsklinikum Augsburg

Augsburg, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Padiatrische Hamatologie und Onkologie

Münster, Germany

Universitätsklinikum Münster

Münster, Germany

Schneider Children's Medical Center of Israel

Petach Tikvah, Central District, Israel

Istituto Giannina Gaslini

Genova, Genoa, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza and Brianza, Italy

Ospedale Pediatrico Bambino Gesù

Roma, Rome, Italy

Ospedale Infantile Regina Margherita

Torino, Turin, Italy

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital

Nagoya, Aiti, Japan

Hyogo Prefectural Kobe Children's Hospital

Kobe, Hyōgo, Japan

Saitama Prefectural Children's Medical Center

Saitama-Shi, Saitama, Japan

National Center for Child Health and Development

Setagaya-Ku, Tokyo, Japan

Osaka City General Hospital

Osaka, Japan

Prinses Maxima Centrum Kinderoncologie

Utrecht, Netherlands

Starship Children's Hospital

Grafton, Auckland, New Zealand

Oslo Universitetssykehus

Oslo, Norway

Instituto Portugues De Oncologia De Lisboa Francisco Gentil

Lisbon, Lisbon District, Portugal

Hospital Universitari Vall d'Hebrón

Barcelona, Spain

Hospital Sant Joan de Déu Barcelona

Barcelona, Spain

Hospital Infantil Universitario Niño Jesús

Madrid, Spain

Hospital Universitario La Fe

Valencia, Spain

Karolinska Universitetssjukhuset Solna

Stockholm, Stockholm County, Sweden

Universitaets - Kinderspital Zürich

Zurich, Switzerland

View Full Details on ClinicalTrials.gov

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NCT05183035

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