Comparison of Different Combination Chemotherapy Regimens in Treating Children With Acute Lymphoblastic Leukemia

NCT00005945 | Completed Phase 3 DMC

• 6 other identifiers: 1991CCG-1991CDR0000067855NCT00005945NCI-2012-02333U10CA098543
• Study Type: interventional
• Target: 3,054
• Locations: 5 countries
• Sites: 130

Brief Summary

RATIONALE: Drugs used in chemotherapy use 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 childhood acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is comparing different combination chemotherapy regimens to see how well they work in treating children with acute lymphoblastic leukemia.

Conditions

Leukemia

Keywords

untreated childhood acute lymphoblastic leukemia; L1 childhood acute lymphoblastic leukemia; L2 childhood acute lymphoblastic leukemia; L3 childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

• Event Free Survival

  The primary outcome index used in examining the randomized treatment groups will be event free survival (EFS) from the time of randomization (i.e., end of Consolidation), where the life table events will consist of the first occurrence of leukemic relapse at any site, death, or occurrence of a second malignancy.

  Time of randomization

Study Arms (7)

Induction Not Randomized

EXPERIMENTAL

Standard Induction (28 Days). M3 Marrow at Day 28 and Off Protocol Therapy.

Drug: cyclophosphamide; Drug: dexamethasone; Drug: methotrexate; Drug: pegaspargase; Drug: vincristine sulfate

Induction and Oral MTX, Double Delayed Intensification CNS

EXPERIMENTAL

Patients with CNS disease at diagnosis, without other unfavorable characteristics. Standard Induction (28 Days). Consolidation (28 days) and in remission Day 21 and at time of randomization, Interim maintenance I (2 months), Delayed intensification I (2 months), Interim maintenance II (2 months), Delayed intensification II (2 months), then Maintenance (12 week cycles). Cranial radiation therapy during the Consolidation phase.

Drug: cyclophosphamide; Drug: cytarabine; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: mercaptopurine; Drug: methotrexate; Drug: pegaspargase; Drug: thioguanine; Drug: vincristine sulfate; Radiation: radiation therapy

Induction and Augmented regimen (IV MTX, Double DI)

EXPERIMENTAL

Patients with unfavorable characteristics. Standard Induction (14 Days), Augmented Induction (Days 14-35), Consolidation (9 weeks), Interim Maintenance I (56 Days), Delayed Intensification I (2 months), Interim Maintenance II (2 months), Delayed Intensification II (2 months), then Maintenance (84 day courses).

Drug: cyclophosphamide; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: mercaptopurine; Drug: methotrexate; Drug: pegaspargase; Drug: thioguanine; Drug: vincristine sulfate; Radiation: radiation therapy

Induction and Oral MTX, Single Delayed Intensification

EXPERIMENTAL

Patients without CNS disease at diagnosis, with favorable cytogenetics. Standard Induction (28 Days). Consolidation (28 days) and in remission Day 21 and at time of randomization, Interim maintenance I (2 months), Delayed intensification I (2 months), Interim maintenance II (2 months) then Maintenance (12 week cycles). Biopsy-proven testicular leukemia pts at diagnosis will receive testicular radiation therapy during the consolidation phase.

Drug: cyclophosphamide; Drug: cytarabine; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: mercaptopurine; Drug: methotrexate; Drug: pegaspargase; Drug: thioguanine; Drug: vincristine sulfate; Radiation: radiation therapy

Induction and Oral MTX, Double Delayed Intensification

EXPERIMENTAL

Patients without CNS disease at diagnosis, with favorable cytogenetics. Standard Induction (28 Days). Consolidation (28 days) and in remission Day 21 and at time of randomization, Interim maintenance I (2 months), Delayed intensification I (2 months), Interim maintenance II (2 months), Delayed intensification II (2 months), then Maintenance (12 week cycles). Biopsy-proven testicular leukemia pts at diagnosis will receive testicular radiation therapy during the consolidation phase.

Drug: cyclophosphamide; Drug: cytarabine; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: mercaptopurine; Drug: methotrexate; Drug: pegaspargase; Drug: thioguanine; Drug: vincristine sulfate; Radiation: radiation therapy

Induction and IV MTX, Single Delayed Intensification

EXPERIMENTAL

Patients without CNS disease at diagnosis, with favorable cytogenetics. Standard Induction (28 Days). Consolidation (28 days) and in remission Day 21 and at time of randomization, Interim maintenance I (2 months), Delayed intensification I (2 months), Interim maintenance II (2 months) then Maintenance (12 week cycles). Biopsy-proven testicular leukemia pts at diagnosis will receive testicular radiation therapy during the consolidation phase.

Drug: cyclophosphamide; Drug: cytarabine; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: mercaptopurine; Drug: methotrexate; Drug: pegaspargase; Drug: thioguanine; Drug: vincristine sulfate; Radiation: radiation therapy

Induction and IV MTX, Double Delayed Intensification

EXPERIMENTAL

Patients without CNS disease at diagnosis, with favorable cytogenetics. Standard Induction (28 Days). Consolidation (28 days) and in event free remission Day 21 and at time of randomization, Interim maintenance I (2 months), Delayed intensification I (2 months), Interim maintenance II (2 months), Delayed intensification II (2 months), then Maintenance (12 week cycles). Biopsy-proven testicular leukemia pts at diagnosis will receive testicular radiation therapy during the consolidation phase.

Drug: cyclophosphamide; Drug: cytarabine; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: mercaptopurine; Drug: methotrexate; Drug: pegaspargase; Drug: thioguanine; Drug: vincristine sulfate; Radiation: radiation therapy

Interventions

cyclophosphamide DRUG

Given IV

Also known as: Cytoxan, NSC-26271

Induction Not Randomized; Induction and Augmented regimen (IV MTX, Double DI); Induction and IV MTX, Double Delayed Intensification; Induction and IV MTX, Single Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification CNS; Induction and Oral MTX, Single Delayed Intensification

cytarabine DRUG

Given IT

Also known as: Cytosine Arabinoside, Ara_C, Cytosar-U, NSC-63878

Induction and Augmented regimen (IV MTX, Double DI); Induction and IV MTX, Double Delayed Intensification; Induction and IV MTX, Single Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification CNS; Induction and Oral MTX, Single Delayed Intensification

daunorubicin hydrochloride DRUG

Given IV

Also known as: Cerubidine, NSC-82151

Induction and Augmented regimen (IV MTX, Double DI)

dexamethasone DRUG

Given PO

Also known as: Decadron, DM, NSC-34521

Induction Not Randomized; Induction and Augmented regimen (IV MTX, Double DI); Induction and IV MTX, Double Delayed Intensification; Induction and IV MTX, Single Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification CNS; Induction and Oral MTX, Single Delayed Intensification

doxorubicin hydrochloride DRUG

Dose 25 g/m² IV Days 0, 7, 14, given over a period of 15 minutes to 2 hours

Also known as: Adriamycin, NSC-123127

Induction and Augmented regimen (IV MTX, Double DI); Induction and IV MTX, Double Delayed Intensification; Induction and IV MTX, Single Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification CNS; Induction and Oral MTX, Single Delayed Intensification

mercaptopurine DRUG

Given PO

Also known as: 6-MP

Induction and Augmented regimen (IV MTX, Double DI); Induction and IV MTX, Double Delayed Intensification; Induction and IV MTX, Single Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification CNS; Induction and Oral MTX, Single Delayed Intensification

methotrexate DRUG

Given PO and IT

Also known as: MTX

Induction Not Randomized; Induction and Augmented regimen (IV MTX, Double DI); Induction and IV MTX, Double Delayed Intensification; Induction and IV MTX, Single Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification CNS; Induction and Oral MTX, Single Delayed Intensification

pegaspargase DRUG

Given IM

Also known as: PEG-asparaginase, Oncaspar, L-asparaginase with polyethylene glycol

Induction Not Randomized; Induction and Augmented regimen (IV MTX, Double DI); Induction and IV MTX, Double Delayed Intensification; Induction and IV MTX, Single Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification CNS; Induction and Oral MTX, Single Delayed Intensification

thioguanine DRUG

Given PO

Also known as: 6 TG, NSC-752

Induction and Augmented regimen (IV MTX, Double DI); Induction and IV MTX, Double Delayed Intensification; Induction and IV MTX, Single Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification CNS; Induction and Oral MTX, Single Delayed Intensification

vincristine sulfate DRUG

Given IV

Also known as: Oncovin, NSC-67574, VCR

Induction Not Randomized; Induction and Augmented regimen (IV MTX, Double DI); Induction and IV MTX, Double Delayed Intensification; Induction and IV MTX, Single Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification CNS; Induction and Oral MTX, Single Delayed Intensification

radiation therapy RADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Induction and Augmented regimen (IV MTX, Double DI); Induction and IV MTX, Double Delayed Intensification; Induction and IV MTX, Single Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification; Induction and Oral MTX, Double Delayed Intensification CNS; Induction and Oral MTX, Single Delayed Intensification

Eligibility Criteria

• Age: 1 Year - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

DISEASE CHARACTERISTICS: * Diagnosis of previously untreated B-cell precursor acute lymphoblastic leukemia * More than 25% L1 or L2 lymphoblasts * No more than 25% L3 lymphoblasts * WBC \< 50,000/mm\^3 * No T-cell precursor acute lymphoblastic leukemia by immunophenotyping * Massive lymphadenopathy, massive splenomegaly, or large mediastinal mass allowed * CNS or testicular leukemia allowed * No patients found to have t(8;14)(q24;q32), t(8;22)(q24;q11), and t(2;8)(p11-p12;q24) (characteristic of Burkitt's lymphoma) PATIENT CHARACTERISTICS: Age: * 1 to 9 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No more than 72 hours since prior intrathecal cytarabine Endocrine therapy: * At least 30 days since prior systemic corticosteroids given for more than 48 hours * Prior corticosteroids for mediastinal mass causing superior mediastinal syndrome allowed * Prior or concurrent inhaled corticosteroids allowed Radiotherapy: * Prior radiotherapy for mediastinal mass causing superior mediastinal syndrome allowed * No concurrent spinal radiotherapy Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (130)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Southern California Permanente Medical Group

Downey, California, 90242, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Children's Hospital Central California

Madera, California, 93638-8762, United States

Location

Children's Hospital and Research Center at Oakland

Oakland, California, 94609-1809, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Kaiser Permanente Medical Center - Sacramento

Sacramento, California, 95825, United States

Location

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

San Diego, California, 92120, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93102, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051-5386, United States

Location

General Robert Huyser Cancer Center at David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

Children's Hospital Cancer Center

Denver, Colorado, 80218, United States

Location

Presbyterian - St. Luke's Medical Center

Denver, Colorado, 80218, United States

Location

Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

Farmington, Connecticut, 06360-7106, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8064, United States

Location

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19899, United States

Location

Lombardi Cancer Center at Georgetown University Medical Center

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

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus

Atlanta, Georgia, 30342, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31201, United States

Location

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31405, United States

Location

Mountain States Tumor Institute - Boise

Boise, Idaho, 83712, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60601, United States

Location

University of Illinois Medical Center

Chicago, Illinois, 60612, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068-1174, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794-9658, United States

Location

Riley Children Cancer Center at Riley Hospital for Children

Indianapolis, Indiana, 46202-5225, United States

Location

Blank Children's Hospital

Des Moines, Iowa, 50308, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0284, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202-3830, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Baystate Regional Cancer Program at D'Amour Center for Cancer Care

Springfield, Massachusetts, 01107, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0914, United States

Location

Josephine Ford Cancer Center at Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007-5364, United States

Location

Breslin Cancer Center at Ingham Regional Medical Center

Lansing, Michigan, 48910, United States

Location

CCOP - Beaumont

Royal Oak, Michigan, 48073-6769, United States

Location

William Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073-6769, United States

Location

St. Mary's - Duluth Clinic Cancer Center

Duluth, Minnesota, 55805, United States

Location

Children's Hospitals and Clinics - Minneapolis/St. Paul

Minneapolis, Minnesota, 55404, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Children's Hospital of Omaha

Omaha, Nebraska, 68114, United States

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, 68198-2168, United States

Location

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109, United States

Location

St. Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112-2094, United States

Location

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, 07503, United States

Location

Valerie Fund Children's Center at Atlantic Health

Summit, New Jersey, 07901, United States

Location

Cancer Center of Albany Medical Center

Albany, New York, 12208, United States

Location

Brooklyn Hospital Center

Brooklyn, New York, 11201-5493, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Brookdale University Hospital and Medical Center

Brooklyn, New York, 11212, United States

Location

Comprehensive Cancer Center at Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Schneider Children's Hospital

New Hyde Park, New York, 11042, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

Long Island Cancer Center at Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233, United States

Location

Dakota Cancer Institute at Innovis Health - Dakota Clinic

Fargo, North Dakota, 58103-4940, United States

Location

Meritcare Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308-1062, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

Cleveland, Ohio, 44106-5065, United States

Location

Columbus Children's Hospital

Columbus, Ohio, 43205-2696, United States

Location

Children's Medical Center - Dayton

Dayton, Ohio, 45404, United States

Location

Toledo Children's Hospital

Toledo, Ohio, 43601, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Doernbecher Children's Hospital at Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-1320, United States

Location

Children's Hospital at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

East Tennessee State University Cancer Center at Johnson City Medical Center

Johnson City, Tennessee, 37614-0622, United States

Location

East Tennessee Children's Hospital

Knoxville, Tennessee, 37901, United States

Location

Vanderbilt Children's Hospital

Nashville, Tennessee, 37232-6310, United States

Location

Texas Tech University Health Sciences Center School of Medicine

Amarillo, Texas, 79106, United States

Location

Children's Hospital of Austin

Austin, Texas, 78701, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

MD Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Covenant Children's Hospital

Lubbock, Texas, 79410, United States

Location

MBCCOP - South Texas Pediatrics

San Antonio, Texas, 78229-3900, United States

Location

Methodist Cancer Center at Methodist Specialty and Transplant Hospital

San Antonio, Texas, 78229-3902, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Deaconess Medical Center

Spokane, Washington, 99210-0248, United States

Location

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98415-0299, United States

Location

West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

Charleston, West Virginia, 25302, United States

Location

Cabell Huntington Hospital

Huntington, West Virginia, 25701, United States

Location

Bellin Memorial Hospital

Green Bay, Wisconsin, 54301, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449-5772, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

Location

Royal Children's Hospital

Brisbane, Queensland, 4029, Australia

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Janeway Children's Health and Rehabilitation Centre

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

Location

IWK Health Centre

Halifax, Nova Scotia, B3J 3G9, Canada

Location

Children's Hospital of Western Ontario

London, Ontario, N6C 2V5, Canada

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Starship Children's Health

Auckland, New Zealand

Location

Swiss Pediatric Oncology Group Bern

Bern, CH 3010, Switzerland

Location

Swiss Pediatric Oncology Group Geneva

Geneva, CH 1211, Switzerland

Location

Swiss Pediatric Oncology Group Lausanne

Lausanne, CH 1011, Switzerland

Location

Related Publications (8)

• Bruggers CS, Moyer-Mileur LJ, Ransdall L: Body composition, bone mineral acquisition, and cardiovascular fitness in children with standard risk acute lymphoblastic leukemia: response to a home-based exercise and nutrition education program. [Abstract] 2006 Pediatric Academic Societies' Annual Meeting, April 29 - May 2, San Francisco, CA. A-3505.46, 2006.

  BACKGROUND

• Matloub Y, Asselin BL, Stork LC, et al.: Outcome of children with T-Cell acute lymphoblastic leukemia (T-ALL) and standard risk (SR) features: results of CCG-1952, CCG-1991 and POG 9404. [Abstract] Blood 104 (11): A-680, 195a, 2004.

  BACKGROUND

• Fernandez CV, Kodish E, Taweel S, Shurin S, Weijer C; Children's Oncology Group. Disclosure of the right of research participants to receive research results: an analysis of consent forms in the Children's Oncology Group. Cancer. 2003 Jun 1;97(11):2904-9. doi: 10.1002/cncr.11391.

  PMID: 12767106 BACKGROUND

• Matloub Y, Bostrom BC, Hunger SP, Stork LC, Angiolillo A, Sather H, La M, Gastier-Foster JM, Heerema NA, Sailer S, Buckley PJ, Thomson B, Cole C, Nachman JB, Reaman G, Winick N, Carroll WL, Devidas M, Gaynon PS. Escalating intravenous methotrexate improves event-free survival in children with standard-risk acute lymphoblastic leukemia: a report from the Children's Oncology Group. Blood. 2011 Jul 14;118(2):243-51. doi: 10.1182/blood-2010-12-322909. Epub 2011 May 11.

  PMID: 21562038 RESULT

• Matloub Y, Bostrom BC, Angiolillo AL, et al.: Children with NCI standard risk acute lymphoblastic leukemia (ALL) and TEL-AML1 or favorable chromosome trisomies are almost certain to be cured with graduated intensity therapy: results of the CCG - 1991 study. [Abstract] Blood 114 (22): A-320, 2009.

  RESULT

• Matloub Y, Bostrom BC, Hunger SP, et al.: Escalating dose intravenous methotrexate without leucovorin rescue during interim maintenance is superior to oral methotrexate for children with standard risk acute lymphoblastic leukemia (SR-ALL): Children's Oncology Group study 1991. [Abstract] Blood 112 (11): A-9, 2008.

  RESULT

• Matloub Y, Angiolillo A, Bostrom B, et al.: Double delayed intensification (DDI) is equivalent to single DI (SDI) in children with National Cancer Institute (NCI) standard-risk acute lymphoblastic leukemia (SR-ALL) treated on Children's Cancer Group (CCG) clinical trial 1991 (CCG-1991). [Abstract] Blood 108 (11): A-146, 2006.

  RESULT

• Matloub Y, Rabin KR, Ji L, Devidas M, Hitzler J, Xu X, Bostrom BC, Stork LC, Winick N, Gastier-Foster JM, Heerema NA, Stonerock E, Carroll WL, Hunger SP, Gaynon PS. Excellent long-term survival of children with Down syndrome and standard-risk ALL: a report from the Children's Oncology Group. Blood Adv. 2019 Jun 11;3(11):1647-1656. doi: 10.1182/bloodadvances.2019032094.

  PMID: 31160295 DERIVED

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Calcium Dobesilate; Doxorubicin; Mercaptopurine; Methotrexate; pegaspargase; Thioguanine; Vincristine; Radiotherapy; Radiation; Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Sulfhydryl Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Aminopterin; Pterins; Pteridines; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Physical Phenomena

Study Officials

• Yousif H. Matloub, MD

  University of Wisconsin, Madison

  STUDY CHAIR

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: July 5, 2000
• First Posted: January 27, 2003
• Study Start: June 1, 2000
• Primary Completion: November 1, 2007
• Study Completion: June 1, 2008
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

CH (3); CA (7); AU (3); NZ (1); US (116)