Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

PHASE3RecruitingINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

October 1, 2022

Primary Completion Date

February 28, 2027

Study Completion Date

April 30, 2031

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Fludarabine

Intravenous (IV) infusion

DRUG

Cytarabine

Intravenous (IV) infusion

DRUG

Gemtuzumab Ozogamicin

Intravenous (IV) infusion

DRUG

Azacitidine

Intravenous (IV) infusion or subcutaneous injection

DRUG

Venetoclax

Orally via tablet or powder suspension

Trial Locations (86)

1023

RECRUITING

Starship Children's Hospital, Grafton

1090

RECRUITING

Sankt Anna-Kinderspital, Vienna

2100

RECRUITING

Rigshospitalet, Copenhagen

3052

RECRUITING

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

4101

RECRUITING

Children's Health Queensland Hospital and Health Service, South Brisbane

6009

RECRUITING

Perth Children's Hospital, Nedlands

8032

RECRUITING

Universitaets - Kinderspital Zürich, Zurich

9000

RECRUITING

Universitair Ziekenhuis Gent, Ghent

10032

RECRUITING

Columbia University Irving Medical Center, New York

10065

RECRUITING

Memorial Sloan Kettering Cancer Center - New York, New York

10126

RECRUITING

Ospedale Infantile Regina Margherita, Torino

11040

RECRUITING

Cohen Children's Medical Center, Queens

13353

RECRUITING

Charité - Universitätsmedizin Berlin, Berlin

16147

RECRUITING

Istituto Giannina Gaslini, Genova

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

19803

RECRUITING

Nemours Alfred I. Dupont Hospital for Children, Wilmington

20900

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori, Monza

28009

RECRUITING

Hospital Infantil Universitario Niño Jesús, Madrid

29203

RECRUITING

Prisma Health Richland Hospital, Columbia

30322

RECRUITING

Children's Healthcare of Atlanta, Atlanta

31059

RECRUITING

CHU de Toulouse - Hôpital des Enfants, Toulouse

32207

RECRUITING

Nemours Children's Specialty Care Jacksonville, Jacksonville

32827

RECRUITING

Nemours Children's Hospital - Orlando, Orlando

33607

RECRUITING

Saint Joseph's Hospital - Tampa, Tampa

33908

RECRUITING

Golisano Children's Hospital of Southwest Florida, Fort Myers

37232

RECRUITING

Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville

39216

RECRUITING

University of Mississippi Medical Center, Jackson

40202

RECRUITING

Norton Children's Hospital, Louisville

43205

RECRUITING

Nationwide Children's Hospital, Columbus

44093

RECRUITING

CHU de Nantes - Hôpital Femme-Enfant-Adolescent, Nantes

46026

RECRUITING

Hospital Universitario La Fe, Valencia

46202

RECRUITING

Indiana University School of Medicine, Indianapolis

48149

RECRUITING

Padiatrische Hamatologie und Onkologie, Münster

48201

RECRUITING

Children's Hospital of Michigan, Detroit

49149

RECRUITING

Universitätsklinikum Münster, Münster

52242

RECRUITING

University of Iowa Stead Family Children's Hospital, Iowa City

55455

RECRUITING

Masonic Cancer Center, Minneapolis

59120

RECRUITING

Hôpital Jeanne de Flandre, Loos

60590

RECRUITING

Universitätsklinikum Frankfurt, Frankfurt

60611

RECRUITING

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

60637

RECRUITING

Comer Children's Hospital, Chicago

63110

RECRUITING

Washington University School of Medicine in St. Louis, St Louis

64108

RECRUITING

The Children's Mercy Hospital - Adele Hall Campus, Kansas City

69008

RECRUITING

Institut d'Hématologie et d'Oncologie Pédiatrique, Lyon

72202

RECRUITING

Arkansas Children's Hospital, Little Rock

75012

RECRUITING

Hôpital Armand-Trousseau, Paris

75019

RECRUITING

Hôpital Universitaire Robert-Debré, Paris

75235

RECRUITING

Harold C. Simmons Comprehensive Cancer Center, Dallas

77030

RECRUITING

Texas Children's Hospital, Houston

80045

RECRUITING

Children's Hospital Colorado, Aurora

84113

RECRUITING

Primary Children's Hospital, Salt Lake City

85016

RECRUITING

Phoenix Children's Hospital, Phoenix

86156

RECRUITING

Universitätsklinikum Augsburg, Augsburg

89135

RECRUITING

Alliance for Childhood Diseases dba Cure 4 The Kids Foundation, Las Vegas

90806

RECRUITING

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

92868

RECRUITING

Children's Hospital of Orange County Main Campus - Orange, Orange

94158

RECRUITING

Benioff Children's Hospital - Mission Bay, San Francisco

96826

RECRUITING

Kapi'olani Medical Center for Women and Children, Honolulu

97239

RECRUITING

Doernbecher Children's Hospital, Portland

98105

RECRUITING

Seattle Children's Hospital, Seattle

4920235

RECRUITING

Schneider Children's Medical Center of Israel, Petach Tikvah

06511

RECRUITING

Yale University, New Haven

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

48109-4259

RECRUITING

C.S. Mott Children's Hospital, Ann Arbor

07960

RECRUITING

Morristown Medical Center, Morristown

38105-3678

RECRUITING

St. Jude Children's Research Hospital, Memphis

T3B 6A8

RECRUITING

Alberta Children's Hospital, Calgary

V6H 3N1

RECRUITING

British Columbia Children's Hospital, Vancouver

R3E 0V9

RECRUITING

CancerCare Manitoba, Winnipeg

B3K 6R8

RECRUITING

Izaak Walton Killam (IWK) Health Center, Halifax

K1H 8L1

RECRUITING

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

RECRUITING

SickKids - The Hospital for Sick Children, Toronto

150 06

RECRUITING

Fakultni nemocnice v Motole, Prague

FI-00290

RECRUITING

Uusi Lastensairaala, Helsinki

00165

RECRUITING

Ospedale Pediatrico Bambino Gesù, Roma

453-8511

RECRUITING

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, Nagoya

650-0047

RECRUITING

Hyogo Prefectural Kobe Children's Hospital, Kobe

330-8777

RECRUITING

Saitama Prefectural Children's Medical Center, Saitama-Shi

157-8535

RECRUITING

National Center for Child Health and Development, Setagaya-Ku

534-0021

RECRUITING

Osaka City General Hospital, Osaka

3584 CS

RECRUITING

Prinses Maxima Centrum Kinderoncologie, Utrecht

0372

RECRUITING

Oslo Universitetssykehus, Oslo

1099-023

RECRUITING

Instituto Portugues De Oncologia De Lisboa Francisco Gentil, Lisbon

08035

RECRUITING

Hospital Universitari Vall d'Hebrón, Barcelona

08950

RECRUITING

Hospital Sant Joan de Déu Barcelona, Barcelona

171 76

RECRUITING

Karolinska Universitetssjukhuset Solna, Stockholm

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Princess Maxima Center for Pediatric Oncology (European Sponsor)

UNKNOWN

collaborator

AbbVie

INDUSTRY

collaborator

Roche-Genentech

INDUSTRY

collaborator

EuPAL

UNKNOWN

lead

PedAL BCU, LLC

OTHER