Back to results

Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

Primary Purpose

Acute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Cyclophosphamide

Cytarabine

Daunorubicin Hydrochloride

Dexamethasone

Doxorubicin Hydrochloride

Leucovorin Calcium

Mercaptopurine

Methotrexate

Pegaspargase

Prednisone

Radiation Therapy

Thioguanine

Vincristine Sulfate

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia

Eligibility Criteria

1 Year - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must be eligible for and enrolled on classification study COG-AALL03B1 Newly diagnosed B-precursor acute lymphoblastic leukemia WBC > 50,000/mm^3 for patients age 1 to 9 Any WBC for patients age 10 to 30 OR patients who have received prior steroid therapy OR patients with testicular disease Whit blood cell (WBC) criteria: Age 1 - 9 years: WBC >= 50,000/uL Age 10 - 30 years: any WBC Prior steroid therapy: any WBC Testicular disease: any WBC Patients shall have had no other prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine Patients receiving prior steroid therapy (as described in AALL03B1) are eligible for study; the dose and duration of previous steroid therapy should be carefully documented All patients and/or their 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 studies must be met Exclusion Criteria: Patients with Down syndrome are ineligible to enroll onto this study

Sites / Locations

Children's Hospital of Alabama
University of Alabama at Birmingham Cancer Center
USA Health Strada Patient Care Center
Banner Children's at Desert
Phoenix Childrens Hospital
Banner University Medical Center - Tucson
Arkansas Children's Hospital
University of Arkansas for Medical Sciences
Kaiser Permanente Downey Medical Center
City of Hope Comprehensive Cancer Center
Loma Linda University Medical Center
Miller Children's and Women's Hospital Long Beach
Children's Hospital Los Angeles
Cedars Sinai Medical Center
Mattel Children's Hospital UCLA
UCLA / Jonsson Comprehensive Cancer Center
Valley Children's Hospital
UCSF Benioff Children's Hospital Oakland
Kaiser Permanente-Oakland
Children's Hospital of Orange County
Lucile Packard Children's Hospital Stanford University
Sutter Medical Center Sacramento
University of California Davis Comprehensive Cancer Center
Rady Children's Hospital - San Diego
UCSF Medical Center-Parnassus
Santa Barbara Cottage Hospital
Children's Hospital Colorado
Presbyterian - Saint Lukes Medical Center - Health One
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
University of Connecticut
Connecticut Children's Medical Center
Yale University
Alfred I duPont Hospital for Children
MedStar Georgetown University Hospital
Children's National Medical Center
Broward Health Medical Center
Lee Memorial Health System
Golisano Children's Hospital of Southwest Florida
University of Florida Health Science Center - Gainesville
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Nemours Children's Clinic-Jacksonville
University of Miami Miller School of Medicine-Sylvester Cancer Center
Nicklaus Children's Hospital
Miami Cancer Institute
AdventHealth Orlando
Nemours Children's Clinic - Orlando
Orlando Health Cancer Institute
Nemours Children's Hospital
Nemours Children's Clinic - Pensacola
Sacred Heart Hospital
Johns Hopkins All Children's Hospital
Saint Joseph's Hospital/Children's Hospital-Tampa
Saint Mary's Hospital
Children's Healthcare of Atlanta - Egleston
Emory University Hospital/Winship Cancer Institute
Augusta University Medical Center
Memorial Health University Medical Center
University of Hawaii Cancer Center
Tripler Army Medical Center
Saint Luke's Cancer Institute - Boise
Lurie Children's Hospital-Chicago
Rush University Medical Center
University of Illinois
University of Chicago Comprehensive Cancer Center
Loyola University Medical Center
Advocate Children's Hospital-Oak Lawn
Advocate Lutheran General Hospital
Southern Illinois University School of Medicine
Indiana University/Melvin and Bren Simon Cancer Center
Riley Hospital for Children
Saint Vincent Hospital and Health Care Center
Blank Children's Hospital
University of Iowa/Holden Comprehensive Cancer Center
University of Kansas Cancer Center
University of Kentucky/Markey Cancer Center
Norton Children's Hospital
Tulane University Health Sciences Center
Children's Hospital New Orleans
Eastern Maine Medical Center
Maine Children's Cancer Program
University of Maryland/Greenebaum Cancer Center
Sinai Hospital of Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Walter Reed National Military Medical Center
Tufts Children's Hospital
Massachusetts General Hospital Cancer Center
Baystate Medical Center
UMass Memorial Medical Center - University Campus
C S Mott Children's Hospital
Wayne State University/Karmanos Cancer Institute
Ascension Saint John Hospital
Michigan State University Clinical Center
Hurley Medical Center
Helen DeVos Children's Hospital at Spectrum Health
Spectrum Health at Butterworth Campus
Bronson Methodist Hospital
Kalamazoo Center for Medical Studies
Beaumont Children's Hospital-Royal Oak
William Beaumont Hospital-Royal Oak
Children's Hospitals and Clinics of Minnesota - Minneapolis
University of Minnesota/Masonic Cancer Center
Mayo Clinic in Rochester
Children's Hospital and Clinic-Saint Paul
University of Mississippi Medical Center
Columbia Regional
University of Missouri - Ellis Fischel
Children's Mercy Hospitals and Clinics
Cardinal Glennon Children's Medical Center
Washington University School of Medicine
Children's Hospital and Medical Center of Omaha
University of Nebraska Medical Center
Nevada Cancer Research Foundation NCORP
Dartmouth Hitchcock Medical Center
Hackensack University Medical Center
Saint Barnabas Medical Center
Morristown Medical Center
Saint Peter's University Hospital
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Newark Beth Israel Medical Center
Saint Joseph's Regional Medical Center
Overlook Hospital
University of New Mexico Cancer Center
Albany Medical Center
Montefiore Medical Center - Moses Campus
Brooklyn Hospital Center
Brookdale Hospital Medical Center
Maimonides Medical Center
Roswell Park Cancer Institute
NYU Winthrop Hospital
The Steven and Alexandra Cohen Children's Medical Center of New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Mount Sinai Hospital
NYP/Weill Cornell Medical Center
Stony Brook University Medical Center
State University of New York Upstate Medical University
New York Medical College
Mission Hospital
UNC Lineberger Comprehensive Cancer Center
Carolinas Medical Center/Levine Cancer Institute
Novant Health Presbyterian Medical Center
Duke University Medical Center
East Carolina University
Wake Forest University Health Sciences
Sanford Broadway Medical Center
Children's Hospital Medical Center of Akron
Cincinnati Children's Hospital Medical Center
Rainbow Babies and Childrens Hospital
Cleveland Clinic Foundation
Nationwide Children's Hospital
Dayton Children's Hospital
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Mercy Children's Hospital
University of Toledo
Tod Children's Hospital - Forum Health
University of Oklahoma Health Sciences Center
Natalie Warren Bryant Cancer Center at Saint Francis
Legacy Emanuel Children's Hospital
Legacy Emanuel Hospital and Health Center
Oregon Health and Science University
Lehigh Valley Hospital - Muhlenberg
Geisinger Medical Center
Penn State Milton S Hershey Medical Center
Penn State Children's Hospital
Children's Hospital of Philadelphia
Children's Oncology Group
Saint Christopher's Hospital for Children
Children's Hospital of Pittsburgh of UPMC
Rhode Island Hospital
Medical University of South Carolina
Prisma Health Richland Hospital
BI-LO Charities Children's Cancer Center
Greenville Cancer Treatment Center
Sanford USD Medical Center - Sioux Falls
T C Thompson Children's Hospital
East Tennessee Childrens Hospital
Vanderbilt University/Ingram Cancer Center
Texas Tech University Health Sciences Center-Amarillo
Dell Children's Medical Center of Central Texas
Driscoll Children's Hospital
Medical City Dallas Hospital
UT Southwestern/Simmons Cancer Center-Dallas
Cook Children's Medical Center
University of Texas Medical Branch
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
M D Anderson Cancer Center
Covenant Children's Hospital
Methodist Children's Hospital of South Texas
University of Texas Health Science Center at San Antonio
Scott and White Memorial Hospital
Primary Children's Hospital
University of Vermont and State Agricultural College
University of Virginia Cancer Center
Inova Fairfax Hospital
Children's Hospital of The King's Daughters
Naval Medical Center - Portsmouth
Virginia Commonwealth University/Massey Cancer Center
Carilion Children's
Seattle Children's Hospital
Providence Sacred Heart Medical Center and Children's Hospital
Mary Bridge Children's Hospital and Health Center
Madigan Army Medical Center
West Virginia University Charleston Division
West Virginia University Healthcare
Saint Vincent Hospital Cancer Center Green Bay
Gundersen Lutheran Medical Center
University of Wisconsin Hospital and Clinics
Marshfield Medical Center-Marshfield
Children's Hospital of Wisconsin
Royal Brisbane and Women's Hospital
Royal Children's Hospital-Brisbane
Women's and Children's Hospital-Adelaide
Royal Children's Hospital
Princess Margaret Hospital for Children
Alberta Children's Hospital
University of Alberta Hospital
British Columbia Children's Hospital
CancerCare Manitoba
Janeway Child Health Centre
IWK Health Centre
Kingston Health Sciences Centre
Children's Hospital
Victoria Hospital
Children's Hospital of Eastern Ontario
Hospital for Sick Children
The Montreal Children's Hospital of the MUHC
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Allan Blair Cancer Centre
Saskatoon Cancer Centre
Starship Children's Hospital
Christchurch Hospital
Wellington Children's Hospital
Swiss Pediatric Oncology Group - Bern
Swiss Pediatric Oncology Group - Geneva
Swiss Pediatric Oncology Group - Lausanne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Arm I

Arm II

Arm III

Arm IV

Arm Description

Patients in arm I receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; and an injection of pegaspargase in week 1.

Patients in arm II will receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; and an injection of pegaspargase in week 1.

Patients in arm III will receive cytarabine, vincristine, daunorubicin, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy by infusion, injection, intrathecally, and by mouth for up to 8 weeks.

Patients in arm IV will receive cytarabine, vincristine, daunorubicin, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy by infusion, injection, intrathecally, and by mouth for up to 8 weeks.

Outcomes

Primary Outcome Measures

Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions

Event Free Probability.

Secondary Outcome Measures

Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)

Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.

Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).

Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells.

Correlation of Early Marrow Response Status With MRD Positive.

Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.

Correlation of Early Marrow Response Status With MRD Negative.

Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)

Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells.

Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).

Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells.

Full Information

NCT ID

NCT00075725

First Posted

January 9, 2004

Last Updated

April 2, 2021

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00075725

Brief Title

Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

Official Title

High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

December 29, 2003 (Actual)

Primary Completion Date

December 31, 2010 (Actual)

Study Completion Date

March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.

Detailed Description

OBJECTIVES: I. Improve the outcome of children with high-risk acute lymphoblastic leukemia treated with 2 different chemotherapy regimens. II. Determine the relative safety and efficacy of dexamethasone given for 14 days vs prednisone given for 28 days during induction. III. Determine the relative safety and efficacy of high-dose methotrexate (5gm/m^2) with leucovorin rescue compared to escalating methotrexate without leucovorin rescue (Capizzi I) during interim maintenance I. IV. Correlate Day 29 minimal residual disease (MRD) with event-free survival (EFS) and overall survival (OS). V. Correlate early marrow response status with day-29 MRD status. VI. Improve outcome by identifying additional high risk patients by Day 29 MRD for treatment with fully augmented Berlin-Frankfurt-Munster (BFM). OUTLINE: This is a randomized, multicenter study. Patients are stratified according to early response (slow early response [SER] vs rapid early response [RER]). Induction therapy: Patients are randomized to 1 of 4 treatment arms. ARM I: Patients receive cytarabine intrathecally (IT) on day 1, vincristine intravenously (IV) and daunorubicin IV on days 1, 8, 15, and 22, dexamethasone orally (PO) or IV twice daily (BID) on days 1-14, methotrexate (MTX) IT on days 8 and 29* and pegaspargase intramuscularly (IM) once on day 4, 5, or 6. NOTE: *Patients with CNS3 disease (WBC > 5/mL in cerebrospinal fluid and positive for blasts on cytospin) also receive MTX IT on days 15 and 22. ARM II: Patients receive induction therapy as in Arm I. ARM III: Patients receive cytarabine, vincristine, daunorubicin, and pegaspargase as in Arm I. Patients also receive prednisone PO or IV BID on days 1-28 and MTX IT on days 8 and 29. ARM IV: Patients receive induction therapy as in Arm III. Patients in all arms are evaluated at day 29 of induction therapy. Patients with M3 disease are removed from study. Patients with M1 disease and less than 1% minimal residual disease (MRD) proceed to consolidation therapy beginning on day 36. Patients with M2 disease OR with MI disease and at least 1% MRD receive extended induction therapy for 2 additional weeks. Patients with SER disease and MLL rearrangements are removed from the study but may be eligible for treatment on protocol COG-AALL0031. Extended induction therapy: Patients continue to receive therapy on the arm to which they were originally randomized. ARMS I and II: Patients receive dexamethasone PO or IV BID on days 1-14, vincristine IV on days 1 and 8, daunorubicin IV on day 1 and pegaspargase IM on day 4, 5, or 6 and are then reevaluated. ARMS III and IV: Patients receive prednisone PO or IV BID on days 1-14, and vincristine, daunorubicin, and pegaspargase as in Arms I and II and are then reevaluated. Patients on all arms who have M1 disease and less than 1% MRD after extended induction proceed to consolidation therapy and continue as SER patients. All other patients are removed from study. Consolidation therapy: All patients receive cyclophosphamide IV over 30 minutes on days 1 and 29, cytarabine IV or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine (MP) PO on days 1-14 and 29-42, vincristine IV on days 15, 22, 43, and 50; pegaspargase IM on days 15 and 43 and MTX* IT on days 1, 8, 15, and 22. Patients with testicular disease also receive radiotherapy to the testes. NOTE: *Patients with CNS3 disease receive MTX on days 1 and 8 only. Interim maintenance therapy I: Patients continue to receive treatment on the arm to which they were originally randomized. ARM I: (escalating-dose MTX) Patients receive vincristine IV and escalating-dose MTX IV on days 1, 11, 21, 31, and 41, pegaspargase IM on days 2 and 22 and MTX IT on days 1 and 21. ARM II: (high-dose MTX) Patients receive vincristine IV and high-dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, MP PO on days 1-56 and IT MTX on days 1 and 29. Patients also receive leucovorin calcium IV every 6 hours for at least 3 doses, beginning 42 hours after start of each MTX infusion. ARM III: (escalating-dose MTX) Patients receive interim maintenance I therapy as in Arm I. ARM IV: (high-dose MTX) Patients receive interim maintenance I therapy as in Arm II. DELAYED INTENSIFICATION THERAPY I: All patients receive vincristine IV on days 1, 8, 15, 43, and 50, dexamethasone PO or IV BID on days 1 to 21 for patients age 1 to 12 OR on days 1-7 and 15-21 for patients age 13 and over, doxorubicin IV on days 1, 8, and 15, pegaspargase IM on day 4, 5, or 6 AND day 43, cyclophosphamide IV over 30 minutes on day 29, cytarabine IV or SC on days 30-33 and 37-40, thioguanine PO on days 29-42 and MTX IT on days 1, 29, and 36.After delayed intensification I, SER patients proceed to interim maintenance II and delayed intensification II. RER patients proceed directly to maintenance. INTERIM MAINTENANCE THERAPY II: All patients receive vincristine IV and MTX IV on days 1, 11, 21, 31, and 41, pegaspargase IM on days 2 and 22; and MTX IT on days 1 and 21. Patients then proceed to delayed intensification II. DELAYED INTENSIFICATION THERAPY II: All patients receive therapy as in delayed intensification I, arm I. CNS3 patients also receive radiotherapy for 3-10 days, beginning on day 29. All other SER patients, patients with MLL rearrangements, and some patients pretreated with steroids (> 48 hours within the week prior to diagnosis) receive prophylactic cranial radiotherapy (CRT) for 8 days, beginning on day 29. Patients then proceed to maintenance therapy. MAINTENANCE THERAPY: All patients receive vincristine IV on days 1, 29, and 57, dexamethasone PO BID on days 1-5, 29-33, and 57-61, MP PO on days 1-84, MTX IT on day 1*; and MTX PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. NOTE: *RER (who did not undergo CRT) patients also receive MTX IT on day 29 for maintenance courses 1-4. In all arms, maintenance therapy repeats every 12 weeks until total duration of therapy is 2 years from the start of interim maintenance I for female patients and 3 years from the start of interim maintenance I for male patients. Patients with testicular disease may receive testicular radiotherapy for 8 days during one of the first 3 courses of maintenance therapy. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3154 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Active Comparator

Arm Description

Arm Title

Arm II

Arm Type

Active Comparator

Arm Description

Arm Title

Arm III

Arm Type

Experimental

Arm Description

Arm Title

Arm IV

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

(-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, 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

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

Cytarabine

Other Intervention Name(s)

.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

Intervention Description

Given IT, SC, or IV

Intervention Type

Drug

Intervention Name(s)

Daunorubicin Hydrochloride

Other Intervention Name(s)

Cerubidin, Cerubidine, Cloridrato de Daunorubicina, Daunoblastin, Daunoblastina, Daunoblastine, Daunomycin Hydrochloride, Daunomycin, hydrochloride, Daunorubicin.HCl, Daunorubicini Hydrochloridum, FI-6339, Ondena, RP-13057, Rubidomycin Hydrochloride, Rubilem

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

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, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex

Intervention Description

Given PO or IV

Intervention Type

Drug

Intervention Name(s)

Doxorubicin Hydrochloride

Other Intervention Name(s)

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, hydroxydaunorubicin, Rubex

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

Leucovorin Calcium

Other Intervention Name(s)

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

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

Mercaptopurine

Other Intervention Name(s)

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

Intervention Description

Given PO

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Other Intervention Name(s)

Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, 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

Intervention Description

Given IT or IV

Intervention Type

Drug

Intervention Name(s)

Pegaspargase

Other Intervention Name(s)

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

Intervention Description

Given IM

Intervention Type

Drug

Intervention Name(s)

Prednisone

Other Intervention Name(s)

.delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone

Intervention Description

Given PO or IV

Intervention Type

Radiation

Intervention Name(s)

Radiation Therapy

Other Intervention Name(s)

Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Intervention Description

Undergo radiation therapy

Intervention Type

Drug

Intervention Name(s)

Thioguanine

Other Intervention Name(s)

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

Intervention Description

Given PO

Intervention Type

Drug

Intervention Name(s)

Vincristine Sulfate

Other Intervention Name(s)

Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions

Description

Event Free Probability.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)

Description

Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.

Time Frame

5 Years

Title

Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).

Description

Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells.

Time Frame

5 years

Title

Correlation of Early Marrow Response Status With MRD Positive.

Description

Time Frame

Day 29

Title

Correlation of Early Marrow Response Status With MRD Negative.

Description

Time Frame

Day 29

Title

Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)

Description

Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells.

Time Frame

5 years

Title

Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).

Description

Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric C Larsen

Organizational Affiliation

Children's Oncology Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Alabama

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

University of Alabama at Birmingham Cancer Center

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

USA Health Strada Patient Care Center

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36604

Country

United States

Facility Name

Banner Children's at Desert

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85202

Country

United States

Facility Name

Phoenix Childrens Hospital

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Facility Name

Banner University Medical Center - Tucson

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85719

Country

United States

Facility Name

Arkansas Children's Hospital

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72202-3591

Country

United States

Facility Name

University of Arkansas for Medical Sciences

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Kaiser Permanente Downey Medical Center

City

Downey

State/Province

California

ZIP/Postal Code

90242

Country

United States

Facility Name

City of Hope Comprehensive Cancer Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

Loma Linda University Medical Center

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

Facility Name

Miller Children's and Women's Hospital Long Beach

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Children's Hospital Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

Facility Name

Cedars Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Mattel Children's Hospital UCLA

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

UCLA / Jonsson Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Valley Children's Hospital

City

Madera

State/Province

California

ZIP/Postal Code

93636

Country

United States

Facility Name

UCSF Benioff Children's Hospital Oakland

City

Oakland

State/Province

California

ZIP/Postal Code

94609

Country

United States

Facility Name

Kaiser Permanente-Oakland

City

Oakland

State/Province

California

ZIP/Postal Code

94611

Country

United States

Facility Name

Children's Hospital of Orange County

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Lucile Packard Children's Hospital Stanford University

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Sutter Medical Center Sacramento

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

University of California Davis Comprehensive Cancer Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Rady Children's Hospital - San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

UCSF Medical Center-Parnassus

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Santa Barbara Cottage Hospital

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93102

Country

United States

Facility Name

Children's Hospital Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Presbyterian - Saint Lukes Medical Center - Health One

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

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

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

University of Connecticut

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030

Country

United States

Facility Name

Connecticut Children's Medical Center

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06106

Country

United States

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

Alfred I duPont Hospital for Children

City

Wilmington

State/Province

Delaware

ZIP/Postal Code

19803

Country

United States

Facility Name

MedStar Georgetown University Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Children's National Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Broward Health Medical Center

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33316

Country

United States

Facility Name

Lee Memorial Health System

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

Facility Name

Golisano Children's Hospital of Southwest Florida

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33908

Country

United States

Facility Name

University of Florida Health Science Center - Gainesville

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Nemours Children's Clinic-Jacksonville

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

University of Miami Miller School of Medicine-Sylvester Cancer Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Nicklaus Children's Hospital

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Miami Cancer Institute

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

AdventHealth Orlando

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

Nemours Children's Clinic - Orlando

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Orlando Health Cancer Institute

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Nemours Children's Hospital

City

Orlando

State/Province

Florida

ZIP/Postal Code

32827

Country

United States

Facility Name

Nemours Children's Clinic - Pensacola

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32504

Country

United States

Facility Name

Sacred Heart Hospital

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32504

Country

United States

Facility Name

Johns Hopkins All Children's Hospital

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33701

Country

United States

Facility Name

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

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

Saint Mary's Hospital

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Children's Healthcare of Atlanta - Egleston

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Emory University Hospital/Winship Cancer Institute

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Augusta University Medical Center

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

Memorial Health University Medical Center

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31404

Country

United States

Facility Name

University of Hawaii Cancer Center

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

Facility Name

Tripler Army Medical Center

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96859

Country

United States

Facility Name

Saint Luke's Cancer Institute - Boise

City

Boise

State/Province

Idaho

ZIP/Postal Code

83712

Country

United States

Facility Name

Lurie Children's Hospital-Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

University of Illinois

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

University of Chicago Comprehensive Cancer Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Loyola University Medical Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Advocate Children's Hospital-Oak Lawn

City

Oak Lawn

State/Province

Illinois

ZIP/Postal Code

60453

Country

United States

Facility Name

Advocate Lutheran General Hospital

City

Park Ridge

State/Province

Illinois

ZIP/Postal Code

60068

Country

United States

Facility Name

Southern Illinois University School of Medicine

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62702

Country

United States

Facility Name

Indiana University/Melvin and Bren Simon Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Riley Hospital for Children

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Saint Vincent Hospital and Health Care Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Blank Children's Hospital

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50309

Country

United States

Facility Name

University of Iowa/Holden Comprehensive Cancer Center

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

University of Kansas Cancer Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

University of Kentucky/Markey Cancer Center

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Norton Children's Hospital

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Tulane University Health Sciences Center

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Children's Hospital New Orleans

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70118

Country

United States

Facility Name

Eastern Maine Medical Center

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Maine Children's Cancer Program

City

Scarborough

State/Province

Maine

ZIP/Postal Code

04074

Country

United States

Facility Name

University of Maryland/Greenebaum Cancer Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Sinai Hospital of Baltimore

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21215

Country

United States

Facility Name

Johns Hopkins University/Sidney Kimmel Cancer Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Walter Reed National Military Medical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20889-5600

Country

United States

Facility Name

Tufts Children's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Massachusetts General Hospital Cancer Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Baystate Medical Center

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01199

Country

United States

Facility Name

UMass Memorial Medical Center - University Campus

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

C S Mott Children's Hospital

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Wayne State University/Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Ascension Saint John Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48236

Country

United States

Facility Name

Michigan State University Clinical Center

City

East Lansing

State/Province

Michigan

ZIP/Postal Code

48824-7016

Country

United States

Facility Name

Hurley Medical Center

City

Flint

State/Province

Michigan

ZIP/Postal Code

48503

Country

United States

Facility Name

Helen DeVos Children's Hospital at Spectrum Health

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Spectrum Health at Butterworth Campus

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Bronson Methodist Hospital

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49007

Country

United States

Facility Name

Kalamazoo Center for Medical Studies

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49008

Country

United States

Facility Name

Beaumont Children's Hospital-Royal Oak

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

William Beaumont Hospital-Royal Oak

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

Children's Hospitals and Clinics of Minnesota - Minneapolis

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Facility Name

University of Minnesota/Masonic Cancer Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Children's Hospital and Clinic-Saint Paul

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55102

Country

United States

Facility Name

University of Mississippi Medical Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Columbia Regional

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65201

Country

United States

Facility Name

University of Missouri - Ellis Fischel

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

Facility Name

Children's Mercy Hospitals and Clinics

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

Country

United States

Facility Name

Cardinal Glennon Children's Medical Center

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Children's Hospital and Medical Center of Omaha

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Facility Name

Nevada Cancer Research Foundation NCORP

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89169

Country

United States

Facility Name

Dartmouth Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Hackensack University Medical Center

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Saint Barnabas Medical Center

City

Livingston

State/Province

New Jersey

ZIP/Postal Code

07039

Country

United States

Facility Name

Morristown Medical Center

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07960

Country

United States

Facility Name

Saint Peter's University Hospital

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Facility Name

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

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

Facility Name

Newark Beth Israel Medical Center

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07112

Country

United States

Facility Name

Saint Joseph's Regional Medical Center

City

Paterson

State/Province

New Jersey

ZIP/Postal Code

07503

Country

United States

Facility Name

Overlook Hospital

City

Summit

State/Province

New Jersey

ZIP/Postal Code

07902

Country

United States

Facility Name

University of New Mexico Cancer Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Albany Medical Center

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

Montefiore Medical Center - Moses Campus

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

Brooklyn Hospital Center

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201

Country

United States

Facility Name

Brookdale Hospital Medical Center

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11212

Country

United States

Facility Name

Maimonides Medical Center

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11219

Country

United States

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

NYU Winthrop Hospital

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

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

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11040

Country

United States

Facility Name

Laura and Isaac Perlmutter Cancer Center at NYU Langone

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Mount Sinai Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

NYP/Weill Cornell Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Stony Brook University Medical Center

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Facility Name

State University of New York Upstate Medical University

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

New York Medical College

City

Valhalla

State/Province

New York

ZIP/Postal Code

10595

Country

United States

Facility Name

Mission Hospital

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

UNC Lineberger Comprehensive Cancer Center

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Carolinas Medical Center/Levine Cancer Institute

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

Facility Name

Novant Health Presbyterian Medical Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

East Carolina University

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Sanford Broadway Medical Center

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58122

Country

United States

Facility Name

Children's Hospital Medical Center of Akron

City

Akron

State/Province

Ohio

ZIP/Postal Code

44308

Country

United States

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Rainbow Babies and Childrens Hospital

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Nationwide Children's Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

Facility Name

Dayton Children's Hospital

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45404

Country

United States

Facility Name

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43606

Country

United States

Facility Name

Mercy Children's Hospital

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43608

Country

United States

Facility Name

University of Toledo

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43614

Country

United States

Facility Name

Tod Children's Hospital - Forum Health

City

Youngstown

State/Province

Ohio

ZIP/Postal Code

44501

Country

United States

Facility Name

University of Oklahoma Health Sciences Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Natalie Warren Bryant Cancer Center at Saint Francis

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Legacy Emanuel Children's Hospital

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Facility Name

Legacy Emanuel Hospital and Health Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Lehigh Valley Hospital - Muhlenberg

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18017

Country

United States

Facility Name

Geisinger Medical Center

City

Danville

State/Province

Pennsylvania

ZIP/Postal Code

17822

Country

United States

Facility Name

Penn State Milton S Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033-0850

Country

United States

Facility Name

Penn State Children's Hospital

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Children's Oncology Group

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Saint Christopher's Hospital for Children

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19134

Country

United States

Facility Name

Children's Hospital of Pittsburgh of UPMC

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Rhode Island Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Prisma Health Richland Hospital

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29203

Country

United States

Facility Name

BI-LO Charities Children's Cancer Center

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Facility Name

Greenville Cancer Treatment Center

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Facility Name

Sanford USD Medical Center - Sioux Falls

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57117-5134

Country

United States

Facility Name

T C Thompson Children's Hospital

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37403

Country

United States

Facility Name

East Tennessee Childrens Hospital

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37916

Country

United States

Facility Name

Vanderbilt University/Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Texas Tech University Health Sciences Center-Amarillo

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Facility Name

Dell Children's Medical Center of Central Texas

City

Austin

State/Province

Texas

ZIP/Postal Code

78723

Country

United States

Facility Name

Driscoll Children's Hospital

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78411

Country

United States

Facility Name

Medical City Dallas Hospital

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

UT Southwestern/Simmons Cancer Center-Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Cook Children's Medical Center

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

University of Texas Medical Branch

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555-0565

Country

United States

Facility Name

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Covenant Children's Hospital

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

Methodist Children's Hospital of South Texas

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

University of Texas Health Science Center at San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Scott and White Memorial Hospital

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Facility Name

Primary Children's Hospital

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84113

Country

United States

Facility Name

University of Vermont and State Agricultural College

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05405

Country

United States

Facility Name

University of Virginia Cancer Center

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Inova Fairfax Hospital

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22042

Country

United States

Facility Name

Children's Hospital of The King's Daughters

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Naval Medical Center - Portsmouth

City

Portsmouth

State/Province

Virginia

ZIP/Postal Code

23708-2197

Country

United States

Facility Name

Virginia Commonwealth University/Massey Cancer Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

Carilion Children's

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24014

Country

United States

Facility Name

Seattle Children's Hospital

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Providence Sacred Heart Medical Center and Children's Hospital

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Mary Bridge Children's Hospital and Health Center

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Madigan Army Medical Center

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98431

Country

United States

Facility Name

West Virginia University Charleston Division

City

Charleston

State/Province

West Virginia

ZIP/Postal Code

25304

Country

United States

Facility Name

West Virginia University Healthcare

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

Saint Vincent Hospital Cancer Center Green Bay

City

Green Bay

State/Province

Wisconsin

ZIP/Postal Code

54301

Country

United States

Facility Name

Gundersen Lutheran Medical Center

City

La Crosse

State/Province

Wisconsin

ZIP/Postal Code

54601

Country

United States

Facility Name

University of Wisconsin Hospital and Clinics

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

Marshfield Medical Center-Marshfield

City

Marshfield

State/Province

Wisconsin

ZIP/Postal Code

54449

Country

United States

Facility Name

Children's Hospital of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Royal Brisbane and Women's Hospital

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Royal Children's Hospital-Brisbane

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Women's and Children's Hospital-Adelaide

City

North Adelaide

State/Province

South Australia

ZIP/Postal Code

5006

Country

Australia

Facility Name

Royal Children's Hospital

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Facility Name

Princess Margaret Hospital for Children

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

Facility Name

Alberta Children's Hospital

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3B 6A8

Country

Canada

Facility Name

University of Alberta Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

British Columbia Children's Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6H 3V4

Country

Canada

Facility Name

CancerCare Manitoba

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 0V9

Country

Canada

Facility Name

Janeway Child Health Centre

City

Saint John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 3V6

Country

Canada

Facility Name

IWK Health Centre

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3K 6R8

Country

Canada

Facility Name

Kingston Health Sciences Centre

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

Country

Canada

Facility Name

Children's Hospital

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Facility Name

Victoria Hospital

City

London

State/Province

Ontario

ZIP/Postal Code

N6K 1C2

Country

Canada

Facility Name

Children's Hospital of Eastern Ontario

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L1

Country

Canada

Facility Name

Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

Facility Name

The Montreal Children's Hospital of the MUHC

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3H 1P3

Country

Canada

Facility Name

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Allan Blair Cancer Centre

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4T 7T1

Country

Canada

Facility Name

Saskatoon Cancer Centre

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 4H4

Country

Canada

Facility Name

Starship Children's Hospital

City

Grafton

State/Province

Auckland

ZIP/Postal Code

1145

Country

New Zealand

Facility Name

Christchurch Hospital

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

Facility Name

Wellington Children's Hospital

City

Wellington

ZIP/Postal Code

6002

Country

New Zealand

Facility Name

Swiss Pediatric Oncology Group - Bern

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Swiss Pediatric Oncology Group - Geneva

City

Geneva

ZIP/Postal Code

1205

Country

Switzerland

Facility Name

Swiss Pediatric Oncology Group - Lausanne

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

33496745

Citation

Advani AS, Larsen E, Laumann K, Luger SM, Liedtke M, Devidas M, Chen Z, Yin J, Foster MC, Claxton D, Coffan K, Tallman MS, Appelbaum FR, Erba H, Stone RM, Hunger SP, McNeer JL, Loh ML, Raetz E, Winick N, Carroll W, Larson RA, Stock W. Comparison of CALGB 10403 (Alliance) and COG AALL0232 toxicity results in young adults with acute lymphoblastic leukemia. Blood Adv. 2021 Jan 26;5(2):504-512. doi: 10.1182/bloodadvances.2020002439.

Results Reference

derived

PubMed Identifier

29284596

Citation

Wood B, Wu D, Crossley B, Dai Y, Williamson D, Gawad C, Borowitz MJ, Devidas M, Maloney KW, Larsen E, Winick N, Raetz E, Carroll WL, Hunger SP, Loh ML, Robins H, Kirsch I. Measurable residual disease detection by high-throughput sequencing improves risk stratification for pediatric B-ALL. Blood. 2018 Mar 22;131(12):1350-1359. doi: 10.1182/blood-2017-09-806521. Epub 2017 Dec 28.

Results Reference

derived

PubMed Identifier

26590194

Citation

Karol SE, Mattano LA Jr, Yang W, Maloney KW, Smith C, Liu C, Ramsey LB, Fernandez CA, Chang TY, Neale G, Cheng C, Mardis E, Fulton R, Scheet P, San Lucas FA, Larsen EC, Loh ML, Raetz EA, Hunger SP, Devidas M, Relling MV. Genetic risk factors for the development of osteonecrosis in children under age 10 treated for acute lymphoblastic leukemia. Blood. 2016 Feb 4;127(5):558-64. doi: 10.1182/blood-2015-10-673848. Epub 2015 Nov 20.

Results Reference

derived

PubMed Identifier

26265699

Citation

Karol SE, Yang W, Van Driest SL, Chang TY, Kaste S, Bowton E, Basford M, Bastarache L, Roden DM, Denny JC, Larsen E, Winick N, Carroll WL, Cheng C, Pei D, Fernandez CA, Liu C, Smith C, Loh ML, Raetz EA, Hunger SP, Scheet P, Jeha S, Pui CH, Evans WE, Devidas M, Mattano LA Jr, Relling MV. Genetics of glucocorticoid-associated osteonecrosis in children with acute lymphoblastic leukemia. Blood. 2015 Oct 8;126(15):1770-6. doi: 10.1182/blood-2015-05-643601. Epub 2015 Aug 11.

Results Reference

derived

PubMed Identifier

26124497

Citation

Borowitz MJ, Wood BL, Devidas M, Loh ML, Raetz EA, Salzer WL, Nachman JB, Carroll AJ, Heerema NA, Gastier-Foster JM, Willman CL, Dai Y, Winick NJ, Hunger SP, Carroll WL, Larsen E. Prognostic significance of minimal residual disease in high risk B-ALL: a report from Children's Oncology Group study AALL0232. Blood. 2015 Aug 20;126(8):964-71. doi: 10.1182/blood-2015-03-633685. Epub 2015 Jun 29.

Results Reference

derived

PubMed Identifier

24970932

Citation

Fernandez CA, Smith C, Yang W, Date M, Bashford D, Larsen E, Bowman WP, Liu C, Ramsey LB, Chang T, Turner V, Loh ML, Raetz EA, Winick NJ, Hunger SP, Carroll WL, Onengut-Gumuscu S, Chen WM, Concannon P, Rich SS, Scheet P, Jeha S, Pui CH, Evans WE, Devidas M, Relling MV. HLA-DRB1*07:01 is associated with a higher risk of asparaginase allergies. Blood. 2014 Aug 21;124(8):1266-76. doi: 10.1182/blood-2014-03-563742. Epub 2014 Jun 26.

Results Reference

derived

Learn more about this trial

We'll reach out to this number within 24 hrs