Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma

NCT01190930 | Active Not Recruiting Phase 3 Results

• 6 other identifiers: AALL0932NCI-2011-02599CDR000068322711-00080U10CA098543U10CA180886
• Study Type: interventional
• Target: 9,350
• Locations: 7 countries
• Sites: 243

Brief Summary

This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). 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. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.

Conditions

Acute Lymphoblastic Leukemia; Adult B Lymphoblastic Lymphoma; Down Syndrome; Philadelphia Chromosome Positive; Ann Arbor Stage I B Lymphoblastic Lymphoma; Ann Arbor Stage II B Lymphoblastic Lymphoma; Childhood B Acute Lymphoblastic Leukemia; Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1; Childhood B Lymphoblastic Lymphoma; Hypodiploid B Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (7)

• Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization

  DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.

  5.7 years

• DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization

  DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.

  5.7 years

• DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens

  DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.

  5.1 years

• DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care

  DFS is calculated as the time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. The 5-year DFS and 95% confidence interval for these patients will be estimated.

  5.1 years

• Sample Collection of Central Path Review Slides in B-LLy Patients

  Percent of B-LLy patients who had adequate/usable samples of samples collected will be reported.

  Up to 1 month

• Event Free Survival (EFS) for B-LLy Patients

  EFS is calculated as the Time from study enrollment to first event (induction failure, relapse, second malignancy, remission death) or date of last contact. The 5-year EFS and 95% confidence interval for these patients will be estimated.

  5 years

• Overall Survival (OS) for B-LLy Patients

  OS is calculated as the time from study enrollment to death or date of last contact. The 5-year OS and 95% confidence interval for these patients will be estimated.

  5 years

Secondary Outcomes (42)

• Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional

  2 Months

• Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional

  1 year

• Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional

  1.7 years

• Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional

  2.5 years

• Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional

  3.2 years

Study Arms (8)

Arm A (risk-adapted chemotherapy)

EXPERIMENTAL

Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.

Drug: Dexamethasone; Other: Laboratory Biomarker Analysis; Drug: Mercaptopurine; Drug: Methotrexate; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Vincristine Sulfate

Arm B (risk-adapted chemotherapy)

EXPERIMENTAL

Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.

Drug: Dexamethasone; Other: Laboratory Biomarker Analysis; Drug: Mercaptopurine; Drug: Methotrexate; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Vincristine Sulfate

Arm B-LLy (4-week cycle maintenance)

EXPERIMENTAL

See Detailed Description.

Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Leucovorin Calcium; Drug: Mercaptopurine; Drug: Methotrexate; Drug: Pegaspargase; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Thioguanine; Drug: Vincristine Sulfate

Arm C (risk-adapted chemotherapy)

EXPERIMENTAL

Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.

Drug: Dexamethasone; Other: Laboratory Biomarker Analysis; Drug: Mercaptopurine; Drug: Methotrexate; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Vincristine Sulfate

Arm D (risk-adapted chemotherapy)

EXPERIMENTAL

Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.

Drug: Dexamethasone; Other: Laboratory Biomarker Analysis; Drug: Mercaptopurine; Drug: Methotrexate; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Vincristine Sulfate

Arm LR-C (risk-adapted chemotherapy)

EXPERIMENTAL

Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.

Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Mercaptopurine; Drug: Methotrexate; Drug: Pegaspargase; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Thioguanine; Drug: Vincristine Sulfate

Arm LR-M (risk-adapted chemotherapy)

EXPERIMENTAL

Patients receive consolidation and maintenance therapy. See detailed description.

Drug: Dexamethasone; Other: Laboratory Biomarker Analysis; Drug: Leucovorin Calcium; Drug: Mercaptopurine; Drug: Methotrexate; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Vincristine Sulfate

Arm SR DS (12-week cycle maintenance)

EXPERIMENTAL

See Detailed Description

Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dexamethasone; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Leucovorin Calcium; Drug: Mercaptopurine; Drug: Methotrexate; Drug: Pegaspargase; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Thioguanine; Drug: Vincristine Sulfate

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A (risk-adapted chemotherapy); Arm B (risk-adapted chemotherapy); Arm B-LLy (4-week cycle maintenance); Arm C (risk-adapted chemotherapy); Arm D (risk-adapted chemotherapy); Arm LR-C (risk-adapted chemotherapy); Arm LR-M (risk-adapted chemotherapy); Arm SR DS (12-week cycle maintenance)

Leucovorin Calcium DRUG

Given PO

Also known as: Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate, Calcium Leucovorin, Calfolex, Calinat, Cehafolin, Citofolin, Citrec, Citrovorum Factor, Cromatonbic Folinico, Dalisol, Disintox, Divical, Ecofol, Emovis, Factor, Citrovorum, Flynoken A, Folaren, Folaxin, FOLI-cell, Foliben, Folidan, Folidar, Folinac, Folinate Calcium, folinic acid, Folinic Acid Calcium Salt Pentahydrate, Folinoral, Folinvit, Foliplus, Folix, Imo, Lederfolat, Lederfolin, Leucosar, leucovorin, Rescufolin, Rescuvolin, Tonofolin, Wellcovorin

Arm B-LLy (4-week cycle maintenance); Arm LR-M (risk-adapted chemotherapy); Arm SR DS (12-week cycle maintenance)

Mercaptopurine DRUG

Given PO

Also known as: 3H-Purine-6-thiol, 6 MP, 6 Thiohypoxanthine, 6 Thiopurine, 6-Mercaptopurine, 6-Mercaptopurine Monohydrate, 6-MP, 6-Purinethiol, 6-Thiopurine, 6-Thioxopurine, 6H-Purine-6-thione, 1,7-dihydro- (9CI), 7-Mercapto-1,3,4,6-tetrazaindene, Alti-Mercaptopurine, Azathiopurine, Bw 57-323H, Flocofil, Ismipur, Leukerin, Leupurin, Mercaleukim, Mercaleukin, Mercaptina, Mercaptopurinum, Mercapurin, Mern, NCI-C04886, Puri-Nethol, Purimethol, Purine, 6-mercapto-, Purine-6-thiol (8CI), Purine-6-thiol, monohydrate, Purinethiol, Purinethol, U-4748, WR-2785

Arm A (risk-adapted chemotherapy); Arm B (risk-adapted chemotherapy); Arm B-LLy (4-week cycle maintenance); Arm C (risk-adapted chemotherapy); Arm D (risk-adapted chemotherapy); Arm LR-C (risk-adapted chemotherapy); Arm LR-M (risk-adapted chemotherapy); Arm SR DS (12-week cycle maintenance)

Methotrexate DRUG

Given IT, PO, or IV

Also known as: Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Jylamvo, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039

Arm A (risk-adapted chemotherapy); Arm B (risk-adapted chemotherapy); Arm B-LLy (4-week cycle maintenance); Arm C (risk-adapted chemotherapy); Arm D (risk-adapted chemotherapy); Arm LR-C (risk-adapted chemotherapy); Arm LR-M (risk-adapted chemotherapy); Arm SR DS (12-week cycle maintenance)

Pegaspargase DRUG

Given IV

Also known as: L-Asparaginase with Polyethylene Glycol, Oncaspar, Oncaspar-IV, PEG-Asparaginase, PEG-L-Asparaginase, PEG-L-Asparaginase (Enzon - Kyowa Hakko), PEGLA, Polyethylene Glycol L-Asparaginase, Polyethylene Glycol-L-Asparaginase

Arm B-LLy (4-week cycle maintenance); Arm LR-C (risk-adapted chemotherapy); Arm SR DS (12-week cycle maintenance)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (risk-adapted chemotherapy); Arm B (risk-adapted chemotherapy); Arm B-LLy (4-week cycle maintenance); Arm C (risk-adapted chemotherapy); Arm D (risk-adapted chemotherapy); Arm LR-C (risk-adapted chemotherapy); Arm LR-M (risk-adapted chemotherapy); Arm SR DS (12-week cycle maintenance)

Questionnaire Administration OTHER

Ancillary studies

Arm A (risk-adapted chemotherapy); Arm B (risk-adapted chemotherapy); Arm B-LLy (4-week cycle maintenance); Arm C (risk-adapted chemotherapy); Arm D (risk-adapted chemotherapy); Arm LR-C (risk-adapted chemotherapy); Arm LR-M (risk-adapted chemotherapy); Arm SR DS (12-week cycle maintenance)

Thioguanine DRUG

Given PO

Also known as: 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

Arm B-LLy (4-week cycle maintenance); Arm LR-C (risk-adapted chemotherapy); Arm SR DS (12-week cycle maintenance)

Vincristine Sulfate DRUG

Given IV

Also known as: Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate

Arm A (risk-adapted chemotherapy); Arm B (risk-adapted chemotherapy); Arm B-LLy (4-week cycle maintenance); Arm C (risk-adapted chemotherapy); Arm D (risk-adapted chemotherapy); Arm LR-C (risk-adapted chemotherapy); Arm LR-M (risk-adapted chemotherapy); Arm SR DS (12-week cycle maintenance)

Cyclophosphamide DRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719

Arm B-LLy (4-week cycle maintenance); Arm LR-C (risk-adapted chemotherapy); Arm SR DS (12-week cycle maintenance)

Cytarabine DRUG

Given IT, IV, or SC

Also known as: .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

Arm B-LLy (4-week cycle maintenance); Arm LR-C (risk-adapted chemotherapy); Arm SR DS (12-week cycle maintenance)

Dexamethasone DRUG

Given orally (PO) or IV

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, LenaDex, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex

Arm A (risk-adapted chemotherapy); Arm B (risk-adapted chemotherapy); Arm B-LLy (4-week cycle maintenance); Arm C (risk-adapted chemotherapy); Arm D (risk-adapted chemotherapy); Arm LR-C (risk-adapted chemotherapy); Arm LR-M (risk-adapted chemotherapy); Arm SR DS (12-week cycle maintenance)

Doxorubicin Hydrochloride DRUG

Given IV

Also known as: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin HCl, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, FI106, hydroxydaunorubicin, Rubex

Arm B-LLy (4-week cycle maintenance); Arm LR-C (risk-adapted chemotherapy); Arm SR DS (12-week cycle maintenance)

Eligibility Criteria

• Age: 1 Year - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932
• Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932
• B-ALL patients must have an initial white blood cell count \< 50,000/uL
• Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible
• Note: for B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met

You may not qualify if:

• With the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932
• Patients receiving prior steroid therapy may be eligible for AALL0932
• Patients with central nervous system 3 (CNS3) leukemia
• CNS status must be known prior to enrollment; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapy
• B-ALL patients with testicular leukemia are not eligible for AALL0932
• T-lymphoblastic lymphoma
• Morphologically unclassifiable lymphoma
• Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
• CNS3-positive disease or testicular involvement
• M2 (5% - 25% blasts) or M3 (\> 25% blasts) marrow
• Female patients who are pregnant are ineligible
• Lactating females are not eligible unless they have agreed not to breastfeed their infants
• Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
• Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation

Sponsors & Collaborators

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

Study Sites (243)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

USA Health Strada Patient Care Center

Mobile, Alabama, 36604, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

Banner Children's at Desert

Mesa, Arizona, 85202, United States

Location

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

Location

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Kaiser Permanente Downey Medical Center

Downey, California, 90242, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Miller Children's and Women's Hospital Long Beach

Long Beach, California, 90806, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Mattel Children's Hospital UCLA

Los Angeles, California, 90095, United States

Location

Valley Children's Hospital

Madera, California, 93636, United States

Location

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304, United States

Location

Sutter Medical Center Sacramento

Sacramento, California, 95816, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

Location

Naval Medical Center -San Diego

San Diego, California, 92134, United States

Location

UCSF Medical Center-Parnassus

San Francisco, California, 94143, United States

Location

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93102, United States

Location

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Lee Memorial Health System

Fort Myers, Florida, 33901, United States

Location

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States

Location

UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States

Location

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

Location

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207, United States

Location

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

Location

Nemours Children's Clinic - Orlando

Orlando, Florida, 32806, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

Nemours Children's Hospital

Orlando, Florida, 32827, United States

Location

Nemours Children's Clinic - Pensacola

Pensacola, Florida, 32504, United States

Location

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, 33607, United States

Location

Saint Mary's Medical Center

West Palm Beach, Florida, 33407, United States

Location

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, 30329, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

Location

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States

Location

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, 60453, United States

Location

Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, 60068, United States

Location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

Location

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States

Location

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Maine Children's Cancer Program

Scarborough, Maine, 04074, United States

Location

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

Tufts Children's Hospital

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236, United States

Location

Michigan State University

East Lansing, Michigan, 48823, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Kalamazoo Center for Medical Studies

Kalamazoo, Michigan, 49008, United States

Location

Corewell Health Children's

Royal Oak, Michigan, 48073, United States

Location

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

Location

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University of Missouri Children's Hospital

Columbia, Missouri, 65212, United States

Location

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109, United States

Location

Nevada Cancer Research Foundation NCORP

Las Vegas, Nevada, 89120, United States

Location

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135, United States

Location

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144, United States

Location

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503, United States

Location

Overlook Hospital

Summit, New Jersey, 07902, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Brooklyn Hospital Center

Brooklyn, New York, 11201, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

Location

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

NYP/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

Location

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606, United States

Location

Mercy Children's Hospital

Toledo, Ohio, 43608, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Natalie Warren Bryant Cancer Center at Saint Francis

Tulsa, Oklahoma, 74136, United States

Location

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227, United States

Location

Legacy Emanuel Hospital and Health Center

Portland, Oregon, 97227, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Penn State Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health Richland Hospital

Columbia, South Carolina, 29203, United States

Location

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605, United States

Location

Greenville Cancer Treatment Center

Greenville, South Carolina, 29605, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

T C Thompson Children's Hospital

Chattanooga, Tennessee, 37403, United States

Location

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916, United States

Location

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Texas Tech University Health Sciences Center-Amarillo

Amarillo, Texas, 79106, United States

Location

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

Location

El Paso Children's Hospital

El Paso, Texas, 79905, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Covenant Children's Hospital

Lubbock, Texas, 79410, United States

Location

UMC Cancer Center / UMC Health System

Lubbock, Texas, 79415, United States

Location

Vannie Cook Children's Clinic

McAllen, Texas, 78503, United States

Location

Children's Hospital of San Antonio

San Antonio, Texas, 78207, United States

Location

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507, United States

Location

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

Location

Carilion Children's

Roanoke, Virginia, 24014, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204, United States

Location

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

West Virginia University Charleston Division

Charleston, West Virginia, 25304, United States

Location

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

Location

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

Location

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

Location

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

John Hunter Children's Hospital

Hunter Regional Mail Centre, New South Wales, 2310, Australia

Location

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Royal Children's Hospital-Brisbane

Herston, Queensland, 4029, Australia

Location

Queensland Children's Hospital

South Brisbane, Queensland, 4101, Australia

Location

Women's and Children's Hospital-Adelaide

North Adelaide, South Australia, 5006, Australia

Location

Monash Medical Center-Clayton Campus

Clayton, Victoria, 3168, Australia

Location

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6008, Australia

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Janeway Child Health Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Children's Hospital

London, Ontario, N6A 5W9, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, H3H 1P3, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Our Lady's Children's Hospital

Dublin, Co Dublin, 12, Ireland

Location

Starship Children's Hospital

Grafton, Auckland, 1145, New Zealand

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

San Jorge Children's Hospital

San Juan, 00912, Puerto Rico

Location

University Pediatric Hospital

San Juan, 00926, Puerto Rico

Location

Swiss Pediatric Oncology Group - Geneva

Geneva, 1205, Switzerland

Location

Swiss Pediatric Oncology Group - Lausanne

Lausanne, 1011, Switzerland

Location

Related Publications (4)

• Chen W, Chang TC, Rabin KR, Raetz EA, Devidas M, Hunger SP, Ramirez NC, Mullighan CG, Loh ML, Wu G. Performance of Two-Phase Designs for the Time-to-Event Outcome and a Case Study Assessing the Relapse Risk Associated With B-ALL Subtypes. JCO Clin Cancer Inform. 2025 May;9:e2400223. doi: 10.1200/CCI-24-00223. Epub 2025 May 2.

  PMID: 40315406 DERIVED

• Chang TC, Chen W, Qu C, Cheng Z, Hedges D, Elsayed A, Pounds SB, Shago M, Rabin KR, Raetz EA, Devidas M, Cheng C, Angiolillo A, Baviskar P, Borowitz M, Burke MJ, Carroll A, Carroll WL, Chen IM, Harvey R, Heerema N, Iacobucci I, Wang JR, Jeha S, Larsen E, Mattano L, Maloney K, Pui CH, Ramirez NC, Salzer W, Willman C, Winick N, Wood B, Hunger SP, Wu G, Mullighan CG, Loh ML. Genomic Determinants of Outcome in Acute Lymphoblastic Leukemia. J Clin Oncol. 2024 Oct 10;42(29):3491-3503. doi: 10.1200/JCO.23.02238. Epub 2024 Aug 9.

  PMID: 39121442 DERIVED

• Rabin KR, Devidas M, Chen Z, Ji L, Kairalla J, Hitzler JK, Yang JJ, Carroll AJ, Heerema NA, Borowitz MJ, Wood BL, Roberts KG, Mullighan CG, Harvey RC, Chen IM, Willman CL, Reshmi SC, Gastier-Foster JM, Bhojwani D, Rheingold SR, Maloney KW, Mattano LA, Larsen EC, Schore RJ, Burke MJ, Salzer WL, Winick NJ, Carroll WL, Raetz EA, Loh ML, Hunger SP, Angiolillo AL. Outcomes in Children, Adolescents, and Young Adults With Down Syndrome and ALL: A Report From the Children's Oncology Group. J Clin Oncol. 2024 Jan 10;42(2):218-227. doi: 10.1200/JCO.23.00389. Epub 2023 Oct 27.

  PMID: 37890117 DERIVED

• Angiolillo AL, Schore RJ, Kairalla JA, Devidas M, Rabin KR, Zweidler-McKay P, Borowitz MJ, Wood B, Carroll AJ, Heerema NA, Relling MV, Hitzler J, Lane AR, Maloney KW, Wang C, Bassal M, Carroll WL, Winick NJ, Raetz EA, Loh ML, Hunger SP. Excellent Outcomes With Reduced Frequency of Vincristine and Dexamethasone Pulses in Standard-Risk B-Lymphoblastic Leukemia: Results From Children's Oncology Group AALL0932. J Clin Oncol. 2021 May 1;39(13):1437-1447. doi: 10.1200/JCO.20.00494. Epub 2021 Jan 7.

  PMID: 33411585 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Down Syndrome

Interventions

Cyclophosphamide; Cytarabine; Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate; Doxorubicin; Leucovorin; Mercaptopurine; azathiopurine; Methotrexate; merphos; pegaspargase; Thioguanine; Vincristine

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Aminoglycosides; Glycosides; Carbohydrates; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Sulfhydryl Compounds; Purines; Aminopterin; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Results Point of Contact

• Title: Results Reporting Coordinator
• Organization: Children's Oncology Group

resultsreportingcoordinator@childrensoncologygroup.org

626-447-0064

Study Officials

• Anne L Angiolillo

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 30, 2010
• Study Start: August 9, 2010
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2026
• Last Updated: March 31, 2026
• Results First Posted: June 23, 2020

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IE (1); CA (14); US (213); AU (9); NZ (2); PR (2); CH (2)