Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome

Sponsor
Children's Oncology Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT02521493
Collaborator
National Cancer Institute (NCI) (NIH)
312
Enrollment
190
Locations
2
Arms
1.6
Patients Per Site

Study Details

Study Description

Brief Summary

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy 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. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine the 2-year event-free-survival (EFS) for children with standard risk Down syndrome (DS) acute myeloid leukemia (AML) (minimal residual disease [MRD]-negative after one cycle of induction therapy) after elimination of high dose (HD) Ara-C (cytarabine) from the treatment regimen.

  2. To determine the 2-year EFS for children with high risk DS AML (MRD-positive after one cycle of induction therapy) after intensification of treatment equivalent to that used for high risk AML in children without DS.

EXPLORATORY OBJECTIVES:
  1. To compare the feasibility and analytical characteristics of flow cytometry, polymerase chain reaction (PCR) and targeted error-corrected sequencing of GATA binding protein 1 (globin transcription factor 1) (GATA1) mutations as methods to detect MRD in DS AML.

  2. To establish a DS AML cell bank of viably frozen bone marrow samples collected at the end of induction and corresponding non-tumor deoxyribonucleic acid (DNA) samples collected at end of Induction 1.

OUTLINE:

INDUCTION I: Patients receive cytarabine intrathecally (IT) on day 1 and intravenously (IV) continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine orally (PO) twice daily (BID) on days 1-4. Induction I continues for a minimum of 28 days.

Patients are assigned to 1 of 2 treatment arms based on their MRD status after completion of Induction I.

ARM A (STANDARD RISK) (Closed to accrual and treatment with amendment #4A 01/07/2019):

INDUCTION II: Patients receive cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine PO BID on days 1-4. Induction II continues for a minimum of 28 days.

INDUCTION III: Patients receive cytarabine, daunorubicin hydrochloride, and thioguanine as in Induction II. Induction III continues for a minimum of 28 days.

INTENSIFICATION I: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 60-120 minutes on days 1-3. Intensification I continues for a minimum of 28 days.

INTENSIFICATION II: Patients receive cytarabine and etoposide as in Intensification I. Intensification II continues for a minimum of 28 days.

ARM B (HIGH RISK):

INDUCTION II: Patients receive high dose cytarabine IV over 1-3 hours every 12 (Q12) hours on days 1-4 and mitoxantrone hydrochloride IV over 15-30 minutes on days 3-6. Induction II continues for a minimum of 28 days.

INTENSIFICATION I: Patients receive high dose cytarabine IV over 1-3 hours Q12 hours and etoposide IV over 90-120 minutes on days 1-5. Intensification I continues for a minimum of 28 days.

INTENSIFICATION II: Patients receive high dose cytarabine IV over 3 hours Q12 hours on days 1, 2, 8, and 9. Patients also receive asparaginase or asparaginase Erwinia chrysanthemi (E. carotovora) intramuscularly (IM) or IV over 30 minutes on days 2 and 9. Intensification II continues for a minimum of 28 days.

After completion of study treatment, patients are followed up at 1 month, monthly for 12 months, every 3 months for 12 months, every 6 months for 3 years, annually for 10 years, and then at relapse.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
312 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome
Actual Study Start Date :
Nov 23, 2015
Anticipated Primary Completion Date :
Jun 30, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Arm A (standard risk)

INDUCTION II: Patients receive cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine PO BID on days 1-4. Induction II continues for a minimum of 28 days. INDUCTION III: Patients receive cytarabine, daunorubicin hydrochloride, and thioguanine as in Induction II. Induction III continues for a minimum of 28 days. INTENSIFICATION I: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 60-120 minutes on days 1-3. Intensification I continues for a minimum of 28 days. INTENSIFICATION II: Patients receive cytarabine and etoposide as in Intensification I. Intensification II continues for a minimum of 28 days. (This arm is closed to accrual and treatment with amendment #4A 01/07/2019)

Drug: Cytarabine
Given IT and IV
Other Names:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-Beta-D-arabinofuranosylcytosine
  • 1.beta.-D-Arabinofuranosylcytosine
  • 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-cell
  • Arabine
  • Arabinofuranosylcytosine
  • Arabinosylcytosine
  • Aracytidine
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine Arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-beta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
  • Drug: Daunorubicin Hydrochloride
    Given IV
    Other Names:
  • Cerubidin
  • Cerubidine
  • Cloridrato de Daunorubicina
  • Daunoblastin
  • Daunoblastina
  • Daunoblastine
  • Daunomycin Hydrochloride
  • Daunomycin, hydrochloride
  • Daunorubicin.HCl
  • Daunorubicini Hydrochloridum
  • FI-6339
  • Ondena
  • RP-13057
  • Rubidomycin Hydrochloride
  • Rubilem
  • Drug: Etoposide
    Given IV
    Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16
  • VP 16-213
  • VP-16
  • VP-16-213
  • VP16
  • Other: Laboratory Biomarker Analysis
    Correlative studies

    Drug: Thioguanine
    Given PO
    Other Names:
  • 2-Amino 6MP
  • 2-Amino-1,7-dihydro-6H-purine-6-thione
  • 2-Amino-6-mercaptopurine
  • 2-Amino-6-purinethiol
  • 2-Aminopurin-6-thiol
  • 2-Aminopurine-6(1H)-thione
  • 2-Aminopurine-6-thiol
  • 2-Aminopurine-6-thiol Hemihydrate
  • 2-Mercapto-6-aminopurine
  • 6-Amino-2-mercaptopurine
  • 6-Mercapto-2-aminopurine
  • 6-Mercaptoguanine
  • 6-TG
  • 6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI)
  • BW 5071
  • Lanvis
  • Tabloid
  • Thioguanine Hemihydrate
  • Thioguanine Hydrate
  • Tioguanin
  • Tioguanine
  • Wellcome U3B
  • WR-1141
  • X 27
  • Experimental: Arm B (high risk)

    INDUCTION II: Patients receive high dose cytarabine IV over 1-3 hours Q12 hours on days 1-4 and mitoxantrone hydrochloride IV over 15-30 minutes on days 3-6. Induction II continues for a minimum of 28 days. INTENSIFICATION I: Patients receive high dose cytarabine IV over 1-3 hours Q12 hours and etoposide IV over 90-120 minutes on days 1-5. Intensification I continues for a minimum of 28 days. INTENSIFICATION II: Patients receive high dose cytarabine IV over 3 hours Q12 hours on days 1, 2, 8, and 9. Patients also receive asparaginase or asparaginase Erwinia chrysanthemi IM or IV over 30 minutes on days 2 and 9. Intensification II continues for a minimum of 28 days.

    Drug: Asparaginase
    Given IM or IV
    Other Names:
  • ASP-1
  • Asparaginase II
  • Asparaginase-E.Coli
  • Colaspase
  • Elspar
  • Kidrolase
  • L-Asnase
  • L-ASP
  • L-Asparaginase
  • L-Asparagine Amidohydrolase
  • Laspar
  • Lcf-ASP
  • Leucogen
  • Leunase
  • MK-965
  • Paronal
  • Re-82-TAD-15
  • Serasa
  • Spectrila
  • Drug: Asparaginase Erwinia chrysanthemi
    Given IM or IV
    Other Names:
  • Crisantaspase
  • Crisantaspasum
  • Erwinase
  • Erwinaze
  • L-asparginase (Erwinia )
  • Drug: Cytarabine
    Given IT and IV
    Other Names:
  • .beta.-Cytosine arabinoside
  • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-.beta.-D-Arabinofuranosylcytosine
  • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
  • 1-Beta-D-arabinofuranosylcytosine
  • 1.beta.-D-Arabinofuranosylcytosine
  • 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
  • 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
  • Alexan
  • Ara-C
  • ARA-cell
  • Arabine
  • Arabinofuranosylcytosine
  • Arabinosylcytosine
  • Aracytidine
  • Aracytin
  • Aracytine
  • Beta-Cytosine Arabinoside
  • CHX-3311
  • Cytarabinum
  • Cytarbel
  • Cytosar
  • Cytosine Arabinoside
  • Cytosine-.beta.-arabinoside
  • Cytosine-beta-arabinoside
  • Erpalfa
  • Starasid
  • Tarabine PFS
  • U 19920
  • U-19920
  • Udicil
  • WR-28453
  • Other: Laboratory Biomarker Analysis
    Correlative studies

    Drug: Mitoxantrone Hydrochloride
    Given IV
    Other Names:
  • CL 232315
  • DHAD
  • DHAQ
  • Dihydroxyanthracenedione Dihydrochloride
  • Mitoxantrone Dihydrochloride
  • Mitoxantroni Hydrochloridum
  • Mitozantrone Hydrochloride
  • Mitroxone
  • Neotalem
  • Novantrone
  • Onkotrone
  • Pralifan
  • Outcome Measures

    Primary Outcome Measures

    1. Event-free survival probability at 2 years [At 2 years]

      The Kaplan-Meier method will be used to estimate 2-year event-free survival (EFS) from the end of Induction I along with 95% log-minus-log transformed confidence limits. EFS is defined as the time from the end of Induction I to failure to achieve remission at the end of Induction II, relapse, occurrence of a second malignancy, or death.

    Other Outcome Measures

    1. Mean length on protocol therapy [6 months]

      The mean number of days patients spent on protocol therapy.

    2. Proportion of patients with an early death [1 month]

      The proportion of patients experiencing an early death in the first month.

    3. Overall survival probability at 2 years. [2 years]

      The Kaplan-Meier method will be used to estimate 2-year Overall Survival (OS) from the end of Induction I along with 95% log-minus-log transformed confidence limits. OS is defined as the time from the end of Induction I to death.

    4. Proportion with treatment related mortality [6 months]

      The proportion of patients experiencing a treatment related death will be reported along with a corresponding confidence interval.

    5. Proportion of patients experiencing a relapse risk [2 years]

      The proportion of patients experiencing a relapse after achieving remission will be reported along with a corresponding confidence interval.

    6. Percentage of patients experiencing grade 3 or adverse events [6 months]

      The percentage of patients experiencing grade 3 or higher toxicity will be reported, where adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

    7. Mean time to absolute neutrophil count (ANC) recovery [6 months]

      The mean time to recovery of ANC to at least 1000/uL will be reported.

    8. Mean duration of hospitalization [6 months]

      Mean number of days patients are hospitalized.

    9. Proportion of patients with at least 1 infection [6 months]

      The proportion of patients having at least one infection will be reported.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    91 Days to 3 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients must have constitutional trisomy 21 (Down syndrome) or trisomy 21 mosaicism (by karyotype or fluorescence in situ hybridization [FISH])

    • Patient has one of the following:

    • Patient has previously untreated de novo AML and meets the criteria for AML with

    = 20% bone marrow blasts as set out in the World Health Organization (WHO) Myeloid Neoplasm classification

    • Attempts to obtain bone marrow either by aspirate or biopsy must be made unless clinically prohibitive; in cases where it is clinically prohibitive, peripheral blood with an excess of 20% blasts and in which adequate flow cytometric and cytogenetics/FISH testing is feasible can be substituted for the marrow exam at diagnosis

    • Patient has cytopenias and/or bone marrow blasts but does not meet the criteria for the diagnosis of AML (WHO Myeloid Neoplasm classification) because of < 20% marrow blasts and meets the criteria for a diagnosis of myelodysplastic syndrome (MDS)

    • For patients who do not meet criteria for AML or MDS as outlined above; patient has a history of transient myeloproliferative disorder (which may or may not have required chemotherapy intervention and:

    • Is > 8 weeks since resolution of transient myeloproliferative disease (TMD) with >= 5% blasts, OR

    • Has an increasing blast count (>= 5%) in serial bone marrow aspirates performed at least 4 weeks apart

    • Children who have previously received chemotherapy, radiation therapy or any anti-leukemic therapy are not eligible for this protocol, with the exception of cytarabine for the treatment of TMD

    • There are no minimal organ function requirements for enrollment on this study

    • Note: Previous cardiac repair with sufficient cardiac function is not an exclusion criteria

    • Each patient's parents or legal guardians must sign a written informed consent

    • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human subjects research must be met

    Exclusion Criteria:
    • Patients with promyelocytic leukemia (French-American-British [FAB] M3)

    • Prior therapy

    • Patients =< 30 days from the last dose of cytarabine used for treatment of TMD

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Children's Hospital of AlabamaBirminghamAlabamaUnited States35233
    2Providence Alaska Medical CenterAnchorageAlaskaUnited States99508
    3Banner Children's at DesertMesaArizonaUnited States85202
    4Phoenix Childrens HospitalPhoenixArizonaUnited States85016
    5Arkansas Children's HospitalLittle RockArkansasUnited States72202-3591
    6Kaiser Permanente Downey Medical CenterDowneyCaliforniaUnited States90242
    7Loma Linda University Medical CenterLoma LindaCaliforniaUnited States92354
    8Miller Children's and Women's Hospital Long BeachLong BeachCaliforniaUnited States90806
    9Children's Hospital Los AngelesLos AngelesCaliforniaUnited States90027
    10Cedars Sinai Medical CenterLos AngelesCaliforniaUnited States90048
    11Valley Children's HospitalMaderaCaliforniaUnited States93636
    12UCSF Benioff Children's Hospital OaklandOaklandCaliforniaUnited States94609
    13Kaiser Permanente-OaklandOaklandCaliforniaUnited States94611
    14Children's Hospital of Orange CountyOrangeCaliforniaUnited States92868
    15Lucile Packard Children's Hospital Stanford UniversityPalo AltoCaliforniaUnited States94304
    16Sutter Medical Center SacramentoSacramentoCaliforniaUnited States95816
    17University of California Davis Comprehensive Cancer CenterSacramentoCaliforniaUnited States95817
    18Rady Children's Hospital - San DiegoSan DiegoCaliforniaUnited States92123
    19Naval Medical Center -San DiegoSan DiegoCaliforniaUnited States92134
    20UCSF Medical Center-Mission BaySan FranciscoCaliforniaUnited States94158
    21Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorranceCaliforniaUnited States90502
    22Children's Hospital ColoradoAuroraColoradoUnited States80045
    23Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical CenterDenverColoradoUnited States80218
    24Connecticut Children's Medical CenterHartfordConnecticutUnited States06106
    25Yale UniversityNew HavenConnecticutUnited States06520
    26Alfred I duPont Hospital for ChildrenWilmingtonDelawareUnited States19803
    27MedStar Georgetown University HospitalWashingtonDistrict of ColumbiaUnited States20007
    28Children's National Medical CenterWashingtonDistrict of ColumbiaUnited States20010
    29Broward Health Medical CenterFort LauderdaleFloridaUnited States33316
    30Golisano Children's Hospital of Southwest FloridaFort MyersFloridaUnited States33908
    31University of Florida Health Science Center - GainesvilleGainesvilleFloridaUnited States32610
    32Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywoodFloridaUnited States33021
    33Nemours Children's Clinic-JacksonvilleJacksonvilleFloridaUnited States32207
    34Palms West Radiation TherapyLoxahatchee GrovesFloridaUnited States33470
    35University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFloridaUnited States33136
    36Nicklaus Children's HospitalMiamiFloridaUnited States33155
    37AdventHealth OrlandoOrlandoFloridaUnited States32803
    38Arnold Palmer Hospital for ChildrenOrlandoFloridaUnited States32806
    39Nemours Children's HospitalOrlandoFloridaUnited States32827
    40Nemours Children's Clinic - PensacolaPensacolaFloridaUnited States32504
    41Sacred Heart HospitalPensacolaFloridaUnited States32504
    42Johns Hopkins All Children's HospitalSaint PetersburgFloridaUnited States33701
    43Saint Joseph's Hospital/Children's Hospital-TampaTampaFloridaUnited States33607
    44Saint Mary's HospitalWest Palm BeachFloridaUnited States33407
    45Children's Healthcare of Atlanta - EglestonAtlantaGeorgiaUnited States30322
    46Memorial Health University Medical CenterSavannahGeorgiaUnited States31404
    47Kapiolani Medical Center for Women and ChildrenHonoluluHawaiiUnited States96826
    48Saint Luke's Cancer Institute - BoiseBoiseIdahoUnited States83712
    49Lurie Children's Hospital-ChicagoChicagoIllinoisUnited States60611
    50University of IllinoisChicagoIllinoisUnited States60612
    51University of Chicago Comprehensive Cancer CenterChicagoIllinoisUnited States60637
    52Advocate Children's Hospital-Oak LawnOak LawnIllinoisUnited States60453
    53Advocate Children's Hospital-Park RidgePark RidgeIllinoisUnited States60068
    54Saint Jude Midwest AffiliatePeoriaIllinoisUnited States61637
    55Southern Illinois University School of MedicineSpringfieldIllinoisUnited States62702
    56Riley Hospital for ChildrenIndianapolisIndianaUnited States46202
    57Saint Vincent Hospital and Health Care CenterIndianapolisIndianaUnited States46260
    58Blank Children's HospitalDes MoinesIowaUnited States50309
    59University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowaUnited States52242
    60University of Kentucky/Markey Cancer CenterLexingtonKentuckyUnited States40536
    61Norton Children's HospitalLouisvilleKentuckyUnited States40202
    62Children's Hospital New OrleansNew OrleansLouisianaUnited States70118
    63Ochsner Medical Center JeffersonNew OrleansLouisianaUnited States70121
    64Eastern Maine Medical CenterBangorMaineUnited States04401
    65Sinai Hospital of BaltimoreBaltimoreMarylandUnited States21215
    66Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMarylandUnited States21287
    67Walter Reed National Military Medical CenterBethesdaMarylandUnited States20889-5600
    68Tufts Children's HospitalBostonMassachusettsUnited States02111
    69Dana-Farber Cancer InstituteBostonMassachusettsUnited States02215
    70Baystate Medical CenterSpringfieldMassachusettsUnited States01199
    71UMass Memorial Medical Center - University CampusWorcesterMassachusettsUnited States01655
    72C S Mott Children's HospitalAnn ArborMichiganUnited States48109
    73Wayne State University/Karmanos Cancer InstituteDetroitMichiganUnited States48201
    74Ascension Saint John HospitalDetroitMichiganUnited States48236
    75Hurley Medical CenterFlintMichiganUnited States48503
    76Helen DeVos Children's Hospital at Spectrum HealthGrand RapidsMichiganUnited States49503
    77Bronson Methodist HospitalKalamazooMichiganUnited States49007
    78Beaumont Children's Hospital-Royal OakRoyal OakMichiganUnited States48073
    79Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolisMinnesotaUnited States55404
    80University of Minnesota/Masonic Cancer CenterMinneapolisMinnesotaUnited States55455
    81Mayo Clinic in RochesterRochesterMinnesotaUnited States55905
    82University of Mississippi Medical CenterJacksonMississippiUnited States39216
    83Columbia RegionalColumbiaMissouriUnited States65201
    84Children's Mercy Hospitals and ClinicsKansas CityMissouriUnited States64108
    85Washington University School of MedicineSaint LouisMissouriUnited States63110
    86Mercy Hospital Saint LouisSaint LouisMissouriUnited States63141
    87University Medical Center of Southern NevadaLas VegasNevadaUnited States89102
    88Sunrise Hospital and Medical CenterLas VegasNevadaUnited States89109
    89Alliance for Childhood Diseases/Cure 4 the Kids FoundationLas VegasNevadaUnited States89135
    90Summerlin Hospital Medical CenterLas VegasNevadaUnited States89144
    91Renown Regional Medical CenterRenoNevadaUnited States89502
    92Dartmouth Hitchcock Medical CenterLebanonNew HampshireUnited States03756
    93Hackensack University Medical CenterHackensackNew JerseyUnited States07601
    94Morristown Medical CenterMorristownNew JerseyUnited States07960
    95Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalNew BrunswickNew JerseyUnited States08903
    96Saint Joseph's Regional Medical CenterPatersonNew JerseyUnited States07503
    97University of New Mexico Cancer CenterAlbuquerqueNew MexicoUnited States87102
    98Presbyterian HospitalAlbuquerqueNew MexicoUnited States87106
    99Albany Medical CenterAlbanyNew YorkUnited States12208
    100Montefiore Medical Center - Moses CampusBronxNew YorkUnited States10467
    101Roswell Park Cancer InstituteBuffaloNew YorkUnited States14263
    102NYU Winthrop HospitalMineolaNew YorkUnited States11501
    103Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew YorkUnited States10016
    104Mount Sinai HospitalNew YorkNew YorkUnited States10029
    105NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew YorkUnited States10032
    106NYP/Weill Cornell Medical CenterNew YorkNew YorkUnited States10065
    107University of RochesterRochesterNew YorkUnited States14642
    108Stony Brook University Medical CenterStony BrookNew YorkUnited States11794
    109State University of New York Upstate Medical UniversitySyracuseNew YorkUnited States13210
    110New York Medical CollegeValhallaNew YorkUnited States10595
    111Mission HospitalAshevilleNorth CarolinaUnited States28801
    112UNC Lineberger Comprehensive Cancer CenterChapel HillNorth CarolinaUnited States27599
    113Carolinas Medical Center/Levine Cancer InstituteCharlotteNorth CarolinaUnited States28203
    114Novant Health Presbyterian Medical CenterCharlotteNorth CarolinaUnited States28204
    115Duke University Medical CenterDurhamNorth CarolinaUnited States27710
    116East Carolina UniversityGreenvilleNorth CarolinaUnited States27834
    117Wake Forest University Health SciencesWinston-SalemNorth CarolinaUnited States27157
    118Sanford Broadway Medical CenterFargoNorth DakotaUnited States58122
    119Children's Hospital Medical Center of AkronAkronOhioUnited States44308
    120Cincinnati Children's Hospital Medical CenterCincinnatiOhioUnited States45229
    121Rainbow Babies and Childrens HospitalClevelandOhioUnited States44106
    122Cleveland Clinic FoundationClevelandOhioUnited States44195
    123Nationwide Children's HospitalColumbusOhioUnited States43205
    124Dayton Children's HospitalDaytonOhioUnited States45404
    125ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalToledoOhioUnited States43606
    126University of Oklahoma Health Sciences CenterOklahoma CityOklahomaUnited States73104
    127Legacy Emanuel Children's HospitalPortlandOregonUnited States97227
    128Oregon Health and Science UniversityPortlandOregonUnited States97239
    129Geisinger Medical CenterDanvillePennsylvaniaUnited States17822
    130Penn State Children's HospitalHersheyPennsylvaniaUnited States17033
    131Children's Hospital of PhiladelphiaPhiladelphiaPennsylvaniaUnited States19104
    132Saint Christopher's Hospital for ChildrenPhiladelphiaPennsylvaniaUnited States19134
    133Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvaniaUnited States15224
    134Rhode Island HospitalProvidenceRhode IslandUnited States02903
    135Medical University of South CarolinaCharlestonSouth CarolinaUnited States29425
    136BI-LO Charities Children's Cancer CenterGreenvilleSouth CarolinaUnited States29605
    137Sanford USD Medical Center - Sioux FallsSioux FallsSouth DakotaUnited States57117-5134
    138T C Thompson Children's HospitalChattanoogaTennesseeUnited States37403
    139East Tennessee Childrens HospitalKnoxvilleTennesseeUnited States37916
    140Saint Jude Children's Research HospitalMemphisTennesseeUnited States38105
    141The Children's Hospital at TriStar CentennialNashvilleTennesseeUnited States37203
    142Vanderbilt University/Ingram Cancer CenterNashvilleTennesseeUnited States37232
    143Texas Tech University Health Sciences Center-AmarilloAmarilloTexasUnited States79106
    144Dell Children's Medical Center of Central TexasAustinTexasUnited States78723
    145Driscoll Children's HospitalCorpus ChristiTexasUnited States78411
    146Medical City Dallas HospitalDallasTexasUnited States75230
    147UT Southwestern/Simmons Cancer Center-DallasDallasTexasUnited States75390
    148El Paso Children's HospitalEl PasoTexasUnited States79905
    149Cook Children's Medical CenterFort WorthTexasUnited States76104
    150Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHoustonTexasUnited States77030
    151Covenant Children's HospitalLubbockTexasUnited States79410
    152UMC Cancer Center / UMC Health SystemLubbockTexasUnited States79415
    153Children's Hospital of San AntonioSan AntonioTexasUnited States78207
    154Methodist Children's Hospital of South TexasSan AntonioTexasUnited States78229
    155University of Texas Health Science Center at San AntonioSan AntonioTexasUnited States78229
    156Primary Children's HospitalSalt Lake CityUtahUnited States84113
    157University of Vermont and State Agricultural CollegeBurlingtonVermontUnited States05405
    158Inova Fairfax HospitalFalls ChurchVirginiaUnited States22042
    159Children's Hospital of The King's DaughtersNorfolkVirginiaUnited States23507
    160Virginia Commonwealth University/Massey Cancer CenterRichmondVirginiaUnited States23298
    161Seattle Children's HospitalSeattleWashingtonUnited States98105
    162Providence Sacred Heart Medical Center and Children's HospitalSpokaneWashingtonUnited States99204
    163Mary Bridge Children's Hospital and Health CenterTacomaWashingtonUnited States98405
    164Madigan Army Medical CenterTacomaWashingtonUnited States98431
    165West Virginia University Charleston DivisionCharlestonWest VirginiaUnited States25304
    166Saint Vincent Hospital Cancer Center Green BayGreen BayWisconsinUnited States54301
    167University of Wisconsin Hospital and ClinicsMadisonWisconsinUnited States53792
    168Children's Hospital of WisconsinMilwaukeeWisconsinUnited States53226
    169John Hunter Children's HospitalHunter Regional Mail CentreNew South WalesAustralia2310
    170Sydney Children's HospitalRandwickNew South WalesAustralia2031
    171The Children's Hospital at WestmeadWestmeadNew South WalesAustralia2145
    172Royal Children's HospitalParkvilleVictoriaAustralia3052
    173Princess Margaret Hospital for ChildrenPerthWestern AustraliaAustralia6008
    174Perth Children's HospitalPerthWestern AustraliaAustralia6009
    175British Columbia Children's HospitalVancouverBritish ColumbiaCanadaV6H 3V4
    176CancerCare ManitobaWinnipegManitobaCanadaR3E 0V9
    177IWK Health CentreHalifaxNova ScotiaCanadaB3K 6R8
    178McMaster Children's Hospital at Hamilton Health SciencesHamiltonOntarioCanadaL8N 3Z5
    179Kingston Health Sciences CentreKingstonOntarioCanadaK7L 2V7
    180Children's HospitalLondonOntarioCanadaN6A 5W9
    181Children's Hospital of Eastern OntarioOttawaOntarioCanadaK1H 8L1
    182Hospital for Sick ChildrenTorontoOntarioCanadaM5G 1X8
    183The Montreal Children's Hospital of the MUHCMontrealQuebecCanadaH3H 1P3
    184Centre Hospitalier Universitaire Sainte-JustineMontrealQuebecCanadaH3T 1C5
    185Centre Hospitalier Universitaire de QuebecQuebecCanadaG1V 4G2
    186Starship Children's HospitalGraftonAucklandNew Zealand1145
    187Christchurch HospitalChristchurchNew Zealand8011
    188San Jorge Children's HospitalSan JuanPuerto Rico00912
    189University Pediatric HospitalSan JuanPuerto Rico00926
    190King Faisal Specialist Hospital and Research CentreRiyadhSaudi Arabia11211

    Sponsors and Collaborators

    • Children's Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Jason N Berman, Children's Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT02521493
    Other Study ID Numbers:
    • AAML1531
    • NCI-2015-00324
    • AAML1531
    • s16-01673
    • AAML1531
    • AAML1531
    • U10CA180886
    First Posted:
    Aug 13, 2015
    Last Update Posted:
    Oct 19, 2021
    Last Verified:
    Oct 1, 2021

    Study Results

    No Results Posted as of Oct 19, 2021