Targeting Better Outcomes for Children With Relapsed Acute Myeloid Leukemia
NCT05183035 · RecruitingThis trial is looking at whether adding venetoclax to a chemotherapy treatment helps children and young adults with acute myeloid leukemia (AML) who have relapsed. The goal is to see if this combination can improve their chances of getting better. Participants will receive either the standard chemotherapy or the chemotherapy plus venetoclax for two treatment cycles.
Locations and contact
This trial is running at 90 locations in 20 countries. 89 of them are currently recruiting.
United States45 locations · 45 recruiting
- Alliance for Childhood Diseases dba Cure 4 The Kids FoundationLas Vegas, NevadaRecruiting
- Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, IllinoisRecruiting
- Arkansas Children's HospitalLittle Rock, ArkansasRecruiting
- Benioff Children's Hospital - Mission BaySan Francisco, CaliforniaRecruiting
- C.S. Mott Children's HospitalAnn Arbor, MichiganRecruiting
- Children's Healthcare of AtlantaAtlanta, GeorgiaRecruiting
- Children's Hospital ColoradoAurora, ColoradoRecruiting
- Children's Hospital of MichiganDetroit, MichiganRecruiting
- Children's Hospital of Orange County Main Campus - OrangeOrange, CaliforniaRecruiting
- Children's Hospital of PhiladelphiaPhiladelphia, PennsylvaniaRecruiting
- Children's Hospital of Richmond at Virginia Commonwealth UniversityRichmond, VirginiaRecruiting
- Children's National - Main HospitalWashington D.C., District of ColumbiaRecruiting
- Cohen Children's Medical CenterQueens, New YorkRecruiting
- Columbia University Irving Medical CenterNew York, New YorkRecruiting
- Comer Children's HospitalChicago, IllinoisRecruiting
- Dana-Farber Cancer InstituteBoston, MassachusettsRecruiting
- Doernbecher Children's HospitalPortland, OregonRecruiting
- Golisano Children's Hospital of Southwest FloridaFort Myers, FloridaRecruiting
- Hackensack University Medical Center, HMHHackensack, New JerseyRecruiting
- Harold C. Simmons Comprehensive Cancer CenterDallas, TexasRecruiting
- Indiana University School of MedicineIndianapolis, IndianaRecruiting
- Kapi'olani Medical Center for Women and ChildrenHonolulu, HawaiiRecruiting
- Masonic Cancer CenterMinneapolis, MinnesotaRecruiting
- Memorial Sloan Kettering Cancer Center - New YorkNew York, New YorkRecruiting
- MemorialCare Miller Children's and Women's Hospital Long BeachLong Beach, CaliforniaRecruiting
- Monroe Carell Jr. Children's Hospital at VanderbiltNashville, TennesseeRecruiting
- Morristown Medical CenterMorristown, New JerseyRecruiting
- Nationwide Children's HospitalColumbus, OhioRecruiting
- Nemours Alfred I. Dupont Hospital for ChildrenWilmington, DelawareRecruiting
- Nemours Children's Hospital - OrlandoOrlando, FloridaRecruiting
- Nemours Children's Specialty Care JacksonvilleJacksonville, FloridaRecruiting
- Norton Children's HospitalLouisville, KentuckyRecruiting
- Phoenix Children's HospitalPhoenix, ArizonaRecruiting
- Primary Children's HospitalSalt Lake City, UtahRecruiting
- Prisma Health Richland HospitalColumbia, South CarolinaRecruiting
- Saint Joseph's Hospital - TampaTampa, FloridaRecruiting
- Seattle Children's HospitalSeattle, WashingtonRecruiting
- St. Jude Children's Research HospitalMemphis, TennesseeRecruiting
- Texas Children's HospitalHouston, TexasRecruiting
- The Children's Mercy Hospital - Adele Hall CampusKansas City, MissouriRecruiting
- University of Florida Health Shands Children's HospitalGainesville, FloridaRecruiting
- University of Iowa Stead Family Children's HospitalIowa City, IowaRecruiting
- University of Mississippi Medical CenterJackson, MississippiRecruiting
- Washington University School of Medicine in St. LouisSt Louis, MissouriRecruiting
- Yale UniversityNew Haven, ConnecticutRecruiting
France6 locations · 6 recruiting
- CHU de Nantes - Hôpital Femme-Enfant-AdolescentNantes, Loire-AtlantiqueRecruiting
- CHU de Toulouse - Hôpital des EnfantsToulouse, Haute-GaronneRecruiting
- Hôpital Armand-TrousseauParis, Île-de-France RegionRecruiting
- Hôpital Jeanne de FlandreLoos, Hauts-de-FranceRecruiting
- Hôpital Universitaire Robert-DebréParis, Île-de-France RegionRecruiting
- Institut d'Hématologie et d'Oncologie PédiatriqueLyon, RhôneRecruiting
Canada6 locations · 5 recruiting
- Alberta Children's HospitalCalgary, AlbertaRecruiting
- CancerCare ManitobaWinnipeg, ManitobaRecruiting
- Children's Hospital of Eastern OntarioOttawa, OntarioRecruiting
- Izaak Walton Killam (IWK) Health CenterHalifax, Nova ScotiaRecruiting
- SickKids - The Hospital for Sick ChildrenToronto, OntarioRecruiting
- British Columbia Children's HospitalVancouver, British ColumbiaCompleted
Germany5 locations · 5 recruiting
- Charité - Universitätsmedizin BerlinBerlinRecruiting
- Padiatrische Hamatologie und OnkologieMünsterRecruiting
- Universitätsklinikum AugsburgAugsburgRecruiting
- Universitätsklinikum FrankfurtFrankfurtRecruiting
- Universitätsklinikum MünsterMünsterRecruiting
Japan5 locations · 5 recruiting
- Hyogo Prefectural Kobe Children's HospitalKobe, HyōgoRecruiting
- Japanese Red Cross Aichi Medical Center Nagoya Daiichi HospitalNagoya, AitiRecruiting
- National Center for Child Health and DevelopmentSetagaya-Ku, TokyoRecruiting
- Osaka City General HospitalOsakaRecruiting
- Saitama Prefectural Children's Medical CenterSaitama-Shi, SaitamaRecruiting
Italy4 locations · 4 recruiting
- Fondazione IRCCS San Gerardo dei TintoriMonza, Monza and BrianzaRecruiting
- Istituto Giannina GasliniGenova, GenoaRecruiting
- Ospedale Infantile Regina MargheritaTorino, TurinRecruiting
- Ospedale Pediatrico Bambino GesùRoma, RomeRecruiting
Spain4 locations · 4 recruiting
- Hospital Infantil Universitario Niño JesúsMadridRecruiting
- Hospital Sant Joan de Déu BarcelonaBarcelonaRecruiting
- Hospital Universitari Vall d'HebrónBarcelonaRecruiting
- Hospital Universitario La FeValenciaRecruiting
Australia3 locations · 3 recruiting
- Children's Health Queensland Hospital and Health ServiceSouth Brisbane, QueenslandRecruiting
- Perth Children's HospitalNedlands, Western AustraliaRecruiting
- The Royal Children's Hospital - Children's Cancer CentreParkville, VictoriaRecruiting
Austria1 location · 1 recruiting
- Sankt Anna-KinderspitalViennaRecruiting
Belgium1 location · 1 recruiting
- Universitair Ziekenhuis GentGhent, Oost-VlaanderenRecruiting
Czechia1 location · 1 recruiting
- Fakultni nemocnice v MotolePrague, PragueRecruiting
Denmark1 location · 1 recruiting
- RigshospitaletCopenhagen, Capital RegionRecruiting
Finland1 location · 1 recruiting
- Uusi LastensairaalaHelsinki, Etelä-Suomen LääniRecruiting
Israel1 location · 1 recruiting
- Schneider Children's Medical Center of IsraelPetach Tikvah, Central DistrictRecruiting
Netherlands1 location · 1 recruiting
- Prinses Maxima Centrum KinderoncologieUtrechtRecruiting
New Zealand1 location · 1 recruiting
- Starship Children's HospitalGrafton, AucklandRecruiting
Norway1 location · 1 recruiting
- Oslo UniversitetssykehusOsloRecruiting
Portugal1 location · 1 recruiting
- Instituto Portugues De Oncologia De Lisboa Francisco GentilLisbon, Lisbon DistrictRecruiting
Sweden1 location · 1 recruiting
- Karolinska Universitetssjukhuset SolnaStockholm, Stockholm CountyRecruiting
Switzerland1 location · 1 recruiting
- Universitaets - Kinderspital ZürichZurichRecruiting
Who can join
Children and young adults aged 29 days to 21 years can join. They must have relapsed AML without certain mutations. Participants must have previously completed other treatments and be fit enough for more intensive chemotherapy. The trial is open to all genders. The trial team will confirm eligibility before enrollment.
What happens during the trial
Participants will be placed in one of two groups by chance. In Arm A, they will receive standard chemotherapy without venetoclax. In Arm B, they will receive chemotherapy plus venetoclax. Both groups will receive treatment for two 42-day cycles, and then their progress will be checked to see if they can get a stem cell transplant or continue with maintenance therapy.
The trial team
The trial is sponsored by PedAL BCU, LLC, with collaboration from several organizations including the Princess Maxima Center for Pediatric Oncology and AbbVie. Dr. Seth Karol from St. Jude Children's Research Hospital is the principal investigator leading the trial.
Important dates
The trial started on October 1, 2022, and is currently enrolling participants. It is expected to finish in April 2031, with the main results expected by February 2027.
Additional information
This is a Phase 3 trial, which means it is testing how well the treatment works and how safe it is. It is FDA-regulated, and about 130 participants will be included.
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