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

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Status: Active

Description

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Locations & Contacts

Alabama

Birmingham
Children's Hospital of Alabama
Status: Active
Contact: Alyssa Terry Reddy Email: helpdesk@childrensoncologygroup.org
University of Alabama at Birmingham Cancer Center
Status: Temporarily closed to accrual
Contact: Alyssa Terry Reddy
Phone: 888-823-5923 Email: ctsucontact@westat.com
Mobile
University of South Alabama
Status: Active
Contact: Felicia Little Wilson
Phone: 251-665-8000

Alaska

Anchorage
Providence Alaska Medical Center
Status: Active
Contact: Brenda J. Wittman
Phone: 907-212-6871 Email: AKPAMC.OncologyResearchSupport@providence.org

Arizona

Mesa
Cardon Children's Medical Center
Status: Active
Contact: Erlyn C. Smith Email: helpdesk@childrensoncologygroup.org
Phoenix
Phoenix Childrens Hospital
Status: Active
Contact: Jessica Boklan
Phone: 602-546-0920
Tucson
The University of Arizona Medical Center-University Campus
Status: Active
Contact: Lisa M. Kopp
Phone: 520-626-9008

Arkansas

Little Rock
Arkansas Children's Hospital
Status: Active
Contact: David L. Becton
Phone: 501-686-8274
University of Arkansas for Medical Sciences
Status: Temporarily closed to accrual
Contact: David L. Becton
Phone: 501-686-8274

California

Downey
Southern California Permanente Medical Group
Status: Active
Contact: Robert Michael Cooper
Phone: 626-564-3455
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Anna Beata Pawlowska
Phone: 800-826-4673 Email: becomingapatient@coh.org
Loma Linda
Loma Linda University Medical Center
Status: Active
Contact: Albert Kheradpour
Phone: 909-558-3375
Long Beach
Miller Children's and Women's Hospital Long Beach
Status: Active
Contact: Pamela Helen-Heilge Kempert Email: helpdesk@childrensoncologygroup.org
Los Angeles
Cedars Sinai Medical Center
Status: Active
Contact: Fataneh (Fae) Majlessipour
Phone: 310-423-8965
Children's Hospital Los Angeles
Status: Active
Contact: Leo Mascarenhas Email: helpdesk@childrensoncologygroup.org
Mattel Children's Hospital UCLA
Status: Active
Contact: William Anthony May Email: helpdesk@childrensoncologygroup.org
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Pamela Helen-Heilge Kempert
Phone: 310-825-6708
Madera
Children's Hospital Central California
Status: Active
Contact: Vonda Lee Crouse Email: helpdesk@childrensoncologygroup.org
Oakland
Children's Hospital and Research Center at Oakland
Status: Active
Contact: Carla Barbara Golden Email: helpdesk@childrensoncologygroup.org
Kaiser Permanente-Oakland
Status: Active
Contact: Steven K. Bergstrom
Phone: 510-891-3400
Orange
Children's Hospital of Orange County
Status: Active
Contact: Elyssa M. Rubin Email: helpdesk@childrensoncologygroup.org
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: Active
Contact: Sheri Lee Spunt
Phone: 650-498-7061 Email: ccto-office@stanford.edu
Sacramento
Sutter Medical Center Sacramento
Status: Active
Contact: Yung Soon Yim
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Marcio Henrique Malogolowkin
Phone: 916-734-3089
San Diego
Naval Medical Center -San Diego
Status: Active
Contact: Shelton August Viola
Phone: 619-532-8712
Rady Children's Hospital - San Diego
Status: Active
Contact: William D. Roberts Email: helpdesk@childrensoncologygroup.org
San Francisco
UCSF Medical Center-Mission Bay
Status: Active
Contact: Mignon Lee-Cheun Loh
Phone: 877-827-3222
UCSF Medical Center-Parnassus
Status: Temporarily closed to accrual
Contact: Mignon Lee-Cheun Loh
Phone: 877-827-3222
Santa Barbara
Santa Barbara Cottage Hospital
Status: Active
Contact: Daniel J. Greenfield
Phone: 805-682-7300
Torrance
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Status: Active
Contact: Eduard H. Panosyan
Phone: 310-222-3621

Colorado

Aurora
Children's Hospital Colorado
Status: Active
Contact: Kelly Wilson Maloney Email: helpdesk@childrensoncologygroup.org
Denver
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Status: Active
Contact: Jennifer Jocelyn Clark Email: helpdesk@childrensoncologygroup.org

Connecticut

Hartford
Connecticut Children's Medical Center
Status: Active
Contact: Michael Scott Isakoff
Phone: 800-579-7822
New Haven
Yale University
Status: Active
Contact: Nina Singh Kadan-Lottick
Phone: 203-785-5702

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: Active
Contact: Evangeline J. Brown Email: helpdesk@childrensoncologygroup.org

District of Columbia

Washington
Children's National Medical Center
Status: Active
Contact: Jeffrey Stuart Dome Email: helpdesk@childrensoncologygroup.org
MedStar Georgetown University Hospital
Status: Active
Contact: Corina Elena Gonzalez
Phone: 202-444-2223

Florida

Fort Lauderdale
Broward Health Medical Center
Status: Active
Contact: Hector M. Rodriguez-Cortes
Phone: 954-355-5346
Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: Active
Contact: Emad K. Salman
Phone: 877-680-0008
Lee Memorial Health System
Status: Temporarily closed to accrual
Contact: Emad K. Salman
Phone: 877-680-0008
Gainesville
University of Florida Health Science Center �� Gainesville
Status: Active
Contact: William Birdsall Slayton
Phone: 352-273-8675 Email: trials@cancer.ufl.edu
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: Active
Contact: Iftikhar Hanif Email: helpdesk@childrensoncologygroup.org
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: Active
Contact: Evangeline J. Brown Email: helpdesk@childrensoncologygroup.org
Miami
Baptist Hospital of Miami
Status: Active
Contact: Doured Daghistani
Phone: 800-599-2456 Email: cancerinfo@baptisthealth.net
Nicklaus Children's Hospital
Status: Active
Contact: Enrique Alberto Escalon Email: helpdesk@childrensoncologygroup.org
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Contact: Julio Cesar Barredo
Phone: 305-243-2647
Orlando
Arnold Palmer Hospital for Children
Status: Active
Contact: Vincent Ferdinando Giusti
Phone: 321-841-7246 Email: CancerClinicalTrials@orlandohealth.com
Florida Hospital Orlando
Status: Active
Contact: Fouad M. Hajjar
Phone: 407-303-2090 Email: FH.Cancer.Research@flhosp.org
Nemours Children's Clinic - Orlando
Status: Temporarily closed to accrual
Contact: Ramamoorthy Nagasubramanian
Phone: 888-823-5923 Email: ctsucontact@westat.com
Nemours Children's Hospital
Status: Active
Contact: Evangeline J. Brown Email: helpdesk@childrensoncologygroup.org
UF Cancer Center at Orlando Health
Status: Temporarily closed to accrual
Contact: Vincent Ferdinando Giusti
Phone: 321-841-7246 Email: CancerClinicalTrials@orlandohealth.com
Pensacola
Nemours Children's Clinic - Pensacola
Status: Active
Contact: Evangeline J. Brown Email: helpdesk@childrensoncologygroup.org
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: Active
Contact: Jennifer Lynne Root Mayer
Phone: 212-639-7202
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: Active
Contact: Mark J. Mogul
Phone: 704-384-5369
Tampa General Hospital
Status: Active
Contact: Juan Felipe Rico
Phone: 813-844-8113 Email: hkourtellis@tgh.org
West Palm Beach
Saint Mary's Hospital
Status: Active
Contact: Narayana Gowda Email: helpdesk@childrensoncologygroup.org

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: Active
Contact: Frank G. Keller Email: helpdesk@childrensoncologygroup.org
Augusta
Augusta University Medical Center
Status: Active
Contact: Colleen H. McDonough
Phone: 706-721-1663 Email: cancer@augusta.edu
Savannah
Memorial University Medical Center
Status: Active
Contact: J. Martin Johnston
Phone: 912-350-8568

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: Active
Contact: Wade T. Kyono
Phone: 808-586-2979
Tripler Army Medical Center
Status: Temporarily closed to accrual
Contact: Tonya Marie Kratovil
Phone: 888-823-5923 Email: ctsucontact@westat.com
University of Hawaii Cancer Center
Status: Temporarily closed to accrual
Contact: Robert W. Wilkinson
Phone: 888-823-5923 Email: ctsucontact@westat.com

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Eugenia Chang Email: helpdesk@childrensoncologygroup.org

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: Active
Contact: Elaine Ruth Morgan Email: helpdesk@childrensoncologygroup.org
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Jennifer Lynn McNeer
Phone: 773-834-7424
University of Illinois
Status: Active
Contact: Mary Lou Schmidt
Phone: 312-355-3046
Maywood
Loyola University Medical Center
Status: Active
Contact: Eugene Suh
Phone: 708-226-4357
Oak Lawn
Advocate Children's Hospital-Oak Lawn
Status: Active
Contact: Rebecca Erin McFall Email: helpdesk@childrensoncologygroup.org
Park Ridge
Advocate Children's Hospital-Park Ridge
Status: Active
Contact: Caroline Yingwen Hu
Phone: 847-384-3621
Advocate Lutheran General Hospital
Status: Temporarily closed to accrual
Contact: Jong-Hyo Kwon
Phone: 847-384-3621
Peoria
Saint Jude Midwest Affiliate
Status: Active
Contact: Pedro A. De Alarcon
Phone: 888-226-4343
Springfield
Southern Illinois University School of Medicine
Status: Active
Contact: Gregory P. Brandt
Phone: 217-545-7929

Indiana

Indianapolis
Riley Hospital for Children
Status: Active
Contact: Kamnesh Ratnakar Pradhan
Phone: 800-248-1199
Saint Vincent Hospital and Health Care Center
Status: Active
Contact: Bassem I. Razzouk
Phone: 317-338-2194 Email: research@stvincent.org

Iowa

Des Moines
Blank Children's Hospital
Status: Active
Contact: Wendy Leigh Woods-Swafford
Phone: 515-241-3305 Email: rbehrens@cancercenterofiowa.com
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Mariko Sato
Phone: 800-237-1225

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Active
Contact: Lars Martin Wagner
Phone: 859-257-3379
Louisville
Norton Children's Hospital
Status: Temporarily closed to accrual
Contact: Kenneth G. Lucas
Phone: 518-262-3368

Louisiana

New Orleans
Children's Hospital New Orleans
Status: Active
Contact: Lolie C. Yu Email: helpdesk@childrensoncologygroup.org
Ochsner Medical Center Jefferson
Status: Active
Contact: Craig Lotterman
Phone: 504-842-3708
Tulane University Health Sciences Center
Status: Temporarily closed to accrual
Contact: Tammuella Chrisentery Singleton
Phone: 504-988-6121

Maine

Bangor
Eastern Maine Medical Center
Status: Active
Contact: Sam Wei Lew
Phone: 207-973-4274
Scarborough
Maine Children's Cancer Program
Status: Active
Contact: Eric C. Larsen
Phone: 207-396-8090 Email: wrighd@mmc.org

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Patrick A. Brown
Phone: 410-955-8804 Email: jhcccro@jhmi.edu
Sinai Hospital of Baltimore
Status: Active
Contact: Jason M. Fixler
Phone: 410-601-6120 Email: pridgely@lifebridgehealth.org
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Teresa Anne York
Phone: 800-888-8823
Bethesda
Walter Reed National Military Medical Center
Status: Active
Contact: Kenneth H. Lieuw
Phone: 301-319-2100

Massachusetts

Boston
Floating Hospital for Children at Tufts Medical Center
Status: Active
Contact: Michael J. Kelly
Phone: 617-636-5535
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Alison M. Friedmann
Phone: 877-726-5130
Springfield
Baystate Medical Center
Status: Active
Contact: Joanna G. Luty
Phone: 413-794-3565 Email: tamara.wrenn@baystatehealth.org
Worcester
University of Massachusetts Medical School
Status: Active
Contact: Christopher P. Keuker
Phone: 508-856-6265

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: Active
Contact: Rajen Mody Email: helpdesk@childrensoncologygroup.org
Detroit
Saint John Hospital and Medical Center
Status: Active
Contact: Adonis N. Lorenzana
Phone: 313-343-3166
Wayne State University / Karmanos Cancer Institute
Status: Temporarily closed to accrual
Contact: Jeffrey Warren Taub
Phone: 313-576-9363
East Lansing
Michigan State University Clinical Center
Status: Active
Contact: Renuka Gera
Phone: 517-975-9547
Flint
Hurley Medical Center
Status: Active
Contact: Nkechi Onwuzurike
Phone: 810-762-8057
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: Active
Contact: David Scott Dickens
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Kalamazoo
Bronson Methodist Hospital
Status: Active
Contact: Katharina Elisabeth Elliott
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Kalamazoo Center for Medical Studies
Status: Temporarily closed to accrual
Contact: Jeffrey S. Lobel
Phone: 888-823-5923 Email: ctsucontact@westat.com
Royal Oak
Beaumont Children's Hospital-Royal Oak
Status: Active
Contact: Laura Kate Gowans
Phone: 248-551-7695

Minnesota

Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Status: Active
Contact: Michael Kerr Richards Email: helpdesk@childrensoncologygroup.org
University of Minnesota / Masonic Cancer Center
Status: Active
Contact: Peter Michael Gordon
Phone: 877-442-3324
Rochester
Mayo Clinic
Status: Active
Contact: Vilmarie Rodriguez
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: Active
Contact: Gail Cranshaw Megason
Phone: 601-815-6700

Missouri

Columbia
Columbia Regional
Status: Active
Contact: Barbara Anne Gruner Email: helpdesk@childrensoncologygroup.org
Kansas City
The Childrens Mercy Hospital
Status: Active
Contact: Keith Jason August Email: helpdesk@childrensoncologygroup.org
Saint Louis
Cardinal Glennon Children's Medical Center
Status: Active
Contact: William Shay Ferguson Email: helpdesk@childrensoncologygroup.org
Mercy Hospital Saint Louis
Status: Active
Contact: Bethany Graham Sleckman
Phone: 800-600-3606 Email: info@siteman.wustl.edu
Washington University School of Medicine
Status: Active
Contact: Robert J. Hayashi
Phone: 800-600-3606 Email: info@siteman.wustl.edu

Nebraska

Omaha
Children's Hospital and Medical Center of Omaha
Status: Active
Contact: Minnie Abromowitch Email: helpdesk@childrensoncologygroup.org
University of Nebraska Medical Center
Status: Active
Contact: Minnie Abromowitch Email: helpdesk@childrensoncologygroup.org

Nevada

Las Vegas
Children's Specialty Center of Nevada II
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Nevada Cancer Research Foundation CCOP
Status: Active
Contact: Jonathan Bernstein
Phone: 702-384-0013
Summerlin Hospital Medical Center
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Sunrise Hospital and Medical Center
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Contact: Sara Chaffee
Phone: 800-639-6918 Email: cancer.research.nurse@dartmouth.edu

New Jersey

Hackensack
Hackensack University Medical Center
Status: Active
Contact: Burton Eliot Appel
Phone: 201-996-2879
Livingston
Saint Barnabas Medical Center
Status: Temporarily closed to accrual
Contact: Stacey Rifkin-Zenenberg
Phone: 973-322-2470
Morristown
Morristown Medical Center
Status: Active
Contact: Steven Lon Halpern
Phone: 201-996-2879
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: Active
Contact: Richard A. Drachtman
Phone: 732-235-8675
Saint Peter's University Hospital
Status: Active
Contact: Nibal Ahmad Zaghloul Email: helpdesk@childrensoncologygroup.org
Newark
Newark Beth Israel Medical Center
Status: Active
Contact: Peri Kamalakar
Phone: 973-926-7230
Paterson
Saint Joseph's Regional Medical Center
Status: Active
Contact: Mary Ann Bonilla Email: helpdesk@childrensoncologygroup.org
Summit
Overlook Hospital
Status: Temporarily closed to accrual
Contact: Steven Lon Halpern
Phone: 201-996-2879

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Active
Contact: Koh B. Boayue
Phone: 505-925-0366 Email: LByatt@nmcca.org

New York

Albany
Albany Medical Center
Status: Active
Contact: Vikramjit Singh Kanwar
Phone: 518-262-3368
Bronx
Montefiore Medical Center - Moses Campus
Status: Temporarily closed to accrual
Contact: Lisa Figueiredo
Phone: 718-904-2730 Email: aecc@aecom.yu.edu
Brooklyn
Brooklyn Hospital Center
Status: Temporarily closed to accrual
Contact: Swayamprabha Sadanandan
Phone: 888-823-5923 Email: ctsucontact@westat.com
Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Barbara J. Bambach
Phone: 877-275-7724
Mineola
NYU Winthrop Hospital
Status: Active
Contact: Mark E. Weinblatt
Phone: 516-663-3115
New Hyde Park
The Steven and Alexandra Cohen Children's Medical Center of New York
Status: Active
Contact: Arlene Sara Redner Email: helpdesk@childrensoncologygroup.org
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Contact: Teena Bhatla
Phone: 212-263-4434 Email: prmc.coordinator@nyumc.org
Memorial Sloan-Kettering Cancer Center
Status: Active
Contact: Neerav Narendra Shukla
Phone: 212-639-7202
Mount Sinai Hospital
Status: Active
Contact: Birte Wistinghausen
Phone: 212-824-7309 Email: CCTO@mssm.edu
Weill Medical College of Cornell University
Status: Active
Contact: Alexander Aledo
Phone: 212-746-1848
Rochester
University of Rochester
Status: Active
Contact: Jeffrey Robert Andolina
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: Active
Contact: Robert Ingalls Parker
Phone: 800-862-2215
Syracuse
State University of New York Upstate Medical University
Status: Active
Contact: Philip M. Monteleone
Phone: 315-464-5476
Valhalla
New York Medical College
Status: Active
Contact: Jessica Cassara Hochberg
Phone: 914-594-3794

North Carolina

Asheville
Mission Hospital-Memorial Campus
Status: Active
Contact: Douglas James Scothorn
Phone: 828-213-4150
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Stuart Harrison Gold
Phone: 877-668-0683 Email: cancerclinicaltrials@med.unc.edu
Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: Active
Contact: Joel A. Kaplan
Phone: 704-355-2884
Novant Health Presbyterian Medical Center
Status: Active
Contact: Jessica Amy Fu Bell
Phone: 704-384-5369
Durham
Duke University Medical Center
Status: Active
Contact: Susan G. Kreissman
Phone: 888-275-3853
Greenville
East Carolina University
Status: Active
Contact: Beng Richard Fuh
Phone: 252-744-2391
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Thomas Bennett Russell
Phone: 336-713-6771

North Dakota

Fargo
Sanford Broadway Medical Center
Status: Active
Contact: Samuel Odame Anim
Phone: 800-437-4010

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: Active
Contact: Steven J. Kuerbitz Email: helpdesk@childrensoncologygroup.org
Cincinnati
Cincinnati Children's Hospital Medical Center
Status: Active
Contact: Maureen Megan O'Brien Email: helpdesk@childrensoncologygroup.org
Cleveland
Cleveland Clinic Foundation
Status: Active
Contact: Aron Flagg
Phone: 866-223-8100
Rainbow Babies and Childrens Hospital
Status: Active
Contact: Yousif (Joe) H. Matloub
Phone: 216-844-5437
Columbus
Nationwide Children's Hospital
Status: Active
Contact: Mark Anthony Ranalli Email: helpdesk@childrensoncologygroup.org
Dayton
Dayton Children's Hospital
Status: Active
Contact: Ayman Aly El-Sheikh Email: helpdesk@childrensoncologygroup.org
Toledo
Mercy Children's Hospital
Status: Temporarily closed to accrual
Contact: Rama Jasty
Phone: 888-823-5923 Email: ctsucontact@westat.com
The Toledo Hospital / Toledo Children's Hospital
Status: Active
Contact: Jamie L. Dargart
Phone: 419-824-1842

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Rene Yvonne McNall-Knapp
Phone: 405-271-8777 Email: ou-clinical-trials@ouhsc.edu
Tulsa
Natalie Warren Bryant Cancer Center at Saint Francis
Status: Temporarily closed to accrual
Contact: Gregory Brian Kirkpatrick
Phone: 918-494-2200

Oregon

Portland
Legacy Emanuel Children's Hospital
Status: Active
Contact: Janice Faye Olson
Phone: 503-413-8199
Legacy Emanuel Hospital and Health Center
Status: Temporarily closed to accrual
Contact: Janice Faye Olson
Phone: 503-413-8199
Oregon Health and Science University
Status: Active
Contact: Susan Joy Lindemulder
Phone: 503-494-1080 Email: trials@ohsu.edu

Pennsylvania

Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: Active
Contact: Lydia Alberta Boateng
Phone: 484-884-2201
Danville
Geisinger Medical Center
Status: Active
Contact: Jagadeesh Ramdas
Phone: 570-271-5251
Hershey
Penn State Children's Hospital
Status: Active
Contact: Lisa MacNabb McGregor Email: helpdesk@childrensoncologygroup.org
Philadelphia
Children's Hospital of Philadelphia
Status: Active
Contact: Susan Robbins Rheingold Email: helpdesk@childrensoncologygroup.org
Saint Christopher's Hospital for Children
Status: Active
Contact: Gregory Emmett Halligan Email: helpdesk@childrensoncologygroup.org
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: Active
Contact: Arthur Kim Ritchey Email: helpdesk@childrensoncologygroup.org

Puerto Rico

San Juan
San Jorge Children's Hospital
Status: Active
Contact: Luis A. Clavell Email: helpdesk@childrensoncologygroup.org
University Pediatric Hospital
Status: Active
Contact: Luis A. Clavell Email: helpdesk@childrensoncologygroup.org

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Contact: Jacqueline M. Kraveka
Phone: 843-792-9321
Columbia
Palmetto Health Richland
Status: Active
Contact: Stuart Louis Cramer
Phone: 803-434-3680
Greenville
BI-LO Charities Children's Cancer Center
Status: Active
Contact: Nichole Leigh Bryant Email: helpdesk@childrensoncologygroup.org
Greenville Cancer Treatment Center
Status: Temporarily closed to accrual
Contact: Cary E. Stroud
Phone: 888-823-5923 Email: ctsucontact@westat.com

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Kayelyn Jean Wagner
Phone: 605-328-1367

Tennessee

Chattanooga
T C Thompson Children's Hospital
Status: Active
Contact: Manoo G. Bhakta Email: helpdesk@childrensoncologygroup.org
Knoxville
East Tennessee Childrens Hospital
Status: Active
Contact: Ray C. Pais
Phone: 865-541-8266
Memphis
St. Jude Children's Research Hospital
Status: Temporarily closed to accrual
Contact: Jeffrey E. Rubnitz Email: helpdesk@childrensoncologygroup.org
Nashville
The Children's Hospital at TriStar Centennial
Status: Active
Contact: Haydar A. Frangoul
Phone: 800-811-8480
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Debra L. Friedman
Phone: 800-811-8480

Texas

Austin
Dell Children's Medical Center of Central Texas
Status: Active
Contact: Amy Catherine Fowler Email: helpdesk@childrensoncologygroup.org
Corpus Christi
Driscoll Children's Hospital
Status: Active
Contact: Nkechi Ifeoma Mba Email: helpdesk@childrensoncologygroup.org
Dallas
Medical City Dallas Hospital
Status: Active
Contact: Stanton Carl Goldman
Phone: 972-566-5588
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Tamra Lynn Slone
Phone: 214-648-7097
El Paso
El Paso Children's Hospital
Status: Active
Contact: Lisa Louise Rubin Hartman Email: helpdesk@childrensoncologygroup.org
Fort Sam Houston
Brooke Army Medical Center
Status: Temporarily closed to accrual
Contact: Della Livesay Howell
Phone: 808-433-6336
Fort Worth
Cook Children's Medical Center
Status: Active
Contact: Kenneth Matthew Heym Email: helpdesk@childrensoncologygroup.org
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: Active
Contact: Karen Ruth Rabin
Phone: 713-798-1354 Email: burton@bcm.edu
M D Anderson Cancer Center
Status: Active
Contact: Cesar A. Nunez
Phone: 713-792-3245
Lubbock
Covenant Children's Hospital
Status: Active
Contact: Kishor Mallikarjun Bhende
Phone: 806-775-8590
University Medical Center
Status: Active
Contact: Mohamad M. Al-Rahawan
Phone: 309-655-3258
McAllen
Vannie Cook Children's Clinic
Status: Active
Contact: Juan Carlos Bernini
Phone: 713-798-1354 Email: burton@bcm.edu
San Antonio
Children's Hospital of San Antonio
Status: Active
Contact: Timothy C. Griffin
Phone: 800-248-1199
Methodist Children's Hospital of South Texas
Status: Active
Contact: Vinod Kumar Gidvani-Diaz Email: helpdesk@childrensoncologygroup.org
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Anne-Marie R. Langevin
Phone: 210-450-3800 Email: CTO@uthscsa.edu
Temple
Scott and White Memorial Hospital
Status: Active
Contact: Guy Howard Grayson
Phone: 254-724-5407

Utah

Salt Lake City
Primary Children's Hospital
Status: Active
Contact: Phillip Evan Barnette Email: helpdesk@childrensoncologygroup.org

Vermont

Burlington
University of Vermont College of Medicine
Status: Active
Contact: Alan Charles Homans
Phone: 802-656-8990

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Active
Contact: William Carl Petersen
Phone: 434-243-6322 Email: JME3D@hscmail.mcc.virginia.edu
Falls Church
Inova Fairfax Hospital
Status: Active
Contact: Marshall A. Schorin
Phone: 703-208-6650 Email: Stephanie.VanBebber@inova.org
Norfolk
Childrens Hospital-King's Daughters
Status: Active
Contact: Eric Jeffrey Lowe Email: helpdesk@childrensoncologygroup.org
Portsmouth
Naval Medical Center - Portsmouth
Status: Temporarily closed to accrual
Contact: Bethany Michelle Mikles
Phone: 757-953-5939
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: Active
Contact: Gita Vasers Massey Email: helpdesk@childrensoncologygroup.org
Roanoke
Carilion Clinic Children's Hospital
Status: Active
Contact: Mandy Meck Atkinson Email: helpdesk@childrensoncologygroup.org

Washington

Seattle
Seattle Children's Hospital
Status: Active
Contact: Douglas S. Hawkins Email: helpdesk@childrensoncologygroup.org
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: Active
Contact: Judy L. Felgenhauer Email: helpdesk@childrensoncologygroup.org
Tacoma
Madigan Army Medical Center
Status: Active
Contact: Melissa Anne Forouhar
Phone: 301-319-2100
Mary Bridge Children's Hospital and Health Center
Status: Active
Contact: Robert G. Irwin Email: helpdesk@childrensoncologygroup.org

West Virginia

Charleston
West Virginia University Charleston
Status: Active
Contact: Ashley E. Meyer
Phone: 304-388-9944
Morgantown
West Virginia University Healthcare
Status: Active
Contact: Stephan R. Paul
Phone: 304-293-7374 Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: Active
Contact: John Robert Hill
Phone: 920-433-8889 Email: Christy.Gilchrist@hshs.org
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Kenneth Brian De Santes
Phone: 800-622-8922
Marshfield
Marshfield Clinic
Status: Active
Contact: Michael John McManus
Phone: 715-389-4457
Milwaukee
Children's Hospital of Wisconsin
Status: Active
Contact: Paul David Harker-Murray
Phone: 214-648-7097

Alberta

Calgary
Alberta Children's Hospital
Status: Active
Contact: Douglas R. Strother Email: helpdesk@childrensoncologygroup.org
Edmonton
University of Alberta Hospital
Status: Active
Contact: Sunil Jayantilal Sunderlal Desai
Phone: 780-407-6615 Email: val.taylor@albertahealthservices.ca

British Columbia

Vancouver
British Columbia Children's Hospital
Status: Active
Contact: David Bryan Dix Email: helpdesk@childrensoncologygroup.org

Manitoba

Winnipeg
CancerCare Manitoba
Status: Active
Contact: Tanya Renae Brown
Phone: 306-766-2213

Newfoundland and Labrador

Saint John's
Janeway Child Health Centre
Status: Active
Contact: Lisa Anne Beresford Goodyear
Phone: 866-722-1126

Nova Scotia

Halifax
IWK Health Centre
Status: Active
Contact: Conrad Vincent Fernandez
Phone: 902-470-8394

Ontario

Hamilton
McMaster Children's Hospital at Hamilton Health Sciences
Status: Active
Contact: Carol Portwine Email: helpdesk@childrensoncologygroup.org
Kingston
Kingston Health Sciences Centre
Status: Active
Contact: Mariana Pradier Silva
Phone: 613-544-2630
London
Children's Hospital
Status: Active
Contact: Shayna M. Zelcer Email: helpdesk@childrensoncologygroup.org
Ottawa
Children's Hospital of Eastern Ontario
Status: Active
Contact: Donna Lynn Johnston Email: helpdesk@childrensoncologygroup.org
Toronto
Hospital for Sick Children
Status: Active
Contact: Johann Hans Hitzler
Phone: 416-813-7654ext2027 Email: jason.mcguire@sickkids.ca

Quebec

Montreal
The Montreal Children's Hospital of the MUHC
Status: Active
Contact: Sharon Barbara Abish Email: helpdesk@childrensoncologygroup.org

Saskatchewan

Regina
Allan Blair Cancer Centre
Status: Temporarily closed to accrual
Contact: Mansoor Mohammad Haq
Phone: 306-766-2213
Saskatoon
Saskatoon Cancer Centre
Status: Active
Contact: Christopher Mpofu
Phone: 306-655-2914

Australia

Clayton
Monash Medical Center-Clayton Campus
Status: Active
Contact: Peter Andrew Downie
Phone: (03) 9928 8111
Herston
Royal Brisbane and Women's Hospital
Status: Temporarily closed to accrual
Contact: Helen Irving
Phone: 888-823-5923 Email: ctsucontact@westat.com
Royal Children's Hospital-Brisbane
Status: Temporarily closed to accrual
Contact: Helen Irving
Phone: 888-823-5923 Email: ctsucontact@westat.com
Hunter Regional Mail Centre
John Hunter Children's Hospital
Status: Active
Contact: Elizabeth Louise Hesketh Email: helpdesk@childrensoncologygroup.org
North Adelaide
Women's and Children's Hospital-Adelaide
Status: Active
Contact: Maria Louise Kirby Email: helpdesk@childrensoncologygroup.org
Parkville
Royal Children's Hospital
Status: Active
Contact: Jordan R. Hansford Email: helpdesk@childrensoncologygroup.org
Perth
Princess Margaret Hospital for Children
Status: Active
Contact: Marianne Barnetson Phillips
Phone: (08) 9340 8222 Email: catherine.cole@health.wa.gov.au
South Brisbane
Lady Cilento Children's Hospital
Status: Active
Contact: Helen Irving Email: helpdesk@childrensoncologygroup.org

Ireland

Dublin
Our Lady's Children's Hospital
Status: Active
Contact: Michael Libero Capra
Phone: (416) 813-7654 ext 2027 Email: jason.mcguire@sickkids.ca

New Zealand

Christchurch
Christchurch Hospital
Status: Active
Contact: Lochie Rodrick Teague Email: helpdesk@childrensoncologygroup.org
Grafton
Starship Children's Hospital
Status: Active
Contact: Lochie Rodrick Teague Email: helpdesk@childrensoncologygroup.org

Switzerland

Geneva
Swiss Pediatric Oncology Group - Geneva
Status: Active
Contact: Marc Ansari
Phone: 031 389 91 89
Lausanne
Swiss Pediatric Oncology Group - Lausanne
Status: Temporarily closed to accrual
Contact: Maja Beck Popovic
Phone: 31 389 91 89

Trial Objectives and Outline

PRIMARY OBJECTIVES:

l. To determine if a maintenance regimen containing weekly oral methotrexate at 40 mg/m^2/week will result in an improved disease free survival (DFS) compared to that containing weekly oral methotrexate at 20 mg/m^2/week in the average-risk (AR) subset of patients with standard-risk B-precursor acute lymphoblastic leukemia (ALL).

II. To determine whether a reduced-pulses maintenance regimen with vincristine (vincristine sulfate)/dexamethasone pulses delivered every 12 weeks can be used without adversely impacting DFS as compared to pulses given every 4 weeks in the AR subset of patients with standard risk B-precursor ALL.

III. To confirm that patients in the low-risk (LR) subset of standard risk B-precursor ALL, based on clinical and cytogenetic features and minimal residual disease (MRD) criteria, can attain a 5 year DFS of at least 95% with either a P9904 based regimen that includes 6 courses of intermediate dose (1 g/m^2 over 24 hours) methotrexate without alkylating agents or anthracyclines (Arm LR-M), or an outpatient based regimen identical to that of AR patients with reduced vincristine/dexamethasone pulses at 12 week intervals during maintenance (Arm LR-C).

IV. To provide standardized treatment and enhanced supportive care to children with standard-risk (SR) Down syndrome-ALL in order to improve outcomes and facilitate further study of this biologically and clinically unique patient subgroup.

V. To improve understanding of the biology of localized B-lineage lymphoblastic lymphoma (B-LLy) and Down syndrome (DS) B-LLy by obtaining biologic data, including fluorescence in situ hybridization (FISH) for recurrent cytogenetic lesions on paraffin specimen, and banking tissue for future research.

VI. To describe the 5-year event free survival (EFS) and overall survival (OS) of patients with Murphy stage I and II B-LLy receiving modified AR B-ALL therapy.

SECONDARY OBJECTIVES:

I. To assess the burden of AR B-ALL therapy as measured by surveys of the child's quality of life, missed days of school/daycare/work by children and parents, family functioning, parental perception of the child's health vulnerability, physical functioning, and emotional distress, 1) overall at different time points during and at the end of therapy, and by 2) comparing children randomized to every 4 week vs. every 12 week dexamethasone/vincristine pulses during maintenance. (Closed to accrual as of April 19, 2013)

II. To characterize the onset, severity, and natural history of vincristine associated neuropathy by physical therapists (or occupational therapists) in children undergoing therapy for AR B-ALL, 1) overall at different time points during and at the end of therapy, and by 2) comparing children randomized to every 4 week vs. every 12 week dexamethasone/vincristine pulses during maintenance. (Closed to accrual as of March 15, 2013)

TERTIARY OBJECTIVES:

I. To explore the correlation of minimal marrow disease (MMD) at diagnosis and outcome for patients with B-LLy.

OUTLINE:

All patients receive induction therapy comprising intrathecal (IT) cytarabine on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) or IV twice daily (BID) on days 1-28; pegaspargase IV over 1-2 hours on day 4; and IT methotrexate* on days 8 and 29. Patients with Philadelphia chromosome-positive disease are eligible to transfer to COG-AALL0622 by day 15 of induction therapy and patients with high-risk (HR) or very high-risk (VHR) disease are eligible to transfer to a COG HR or VHR trial at the end of induction therapy. Patients with standard-risk disease with Down syndrome (DS) who have bone marrow minimal residual disease 0.01% are eligible to transfer to the DS stratum of the HR trial. Patients with induction failure (defined as M3 [> 25% lymphoblasts] on day 29) may be eligible for the COG VHR-acute lymphoblastic leukemia study.

NOTE: *Patients with DS also receive oral leucovorin calcium every 12 hours on days 10-11 and 31-32.

STANDARD-RISK WITH DOWN SYNDROME:

Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; mercaptopurine PO on days 1-28; IT methotrexate on days 1, 8, and 15; and leucovorin calcium PO every 12 hours on days 3-4, 10-11, and 17-18. Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on day 31; and leucovorin calcium PO every 12 hours on days 36-34. Delayed-intensification therapy (8 weeks): Patients receive dexamethasone PO or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO on days 29-42; cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 29-32 and 33-39; IT methotrexate on days 1 and 29; and leucovorin calcium PO every 12 hours on days 3-4 and 31-32. Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on days 1 and 31; and leucovorin calcium PO every 12 hours on days 3-4 and 33-34. Maintenance therapy: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Courses repeat every 12 weeks for 2 years (timed from the start of interim maintenance I therapy).

AVERAGE-RISK:

Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; mercaptopurine PO on days 1-28; and IT methotrexate on days 1, 8, and 15.Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on day 31. Delayed intensification therapy (8 weeks): Patients receive dexamethasone PO or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO on days 29-42; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; and IT methotrexate on days 1 and 29. Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on days 1 and 31. Maintenance therapy: Patients are randomized to 1 of 4 maintenance therapy treatment arms.

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

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

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

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

In all arms, maintenance therapy courses repeat every 12 weeks for 2 years for girls and for 3 years for boys (timed from the start of interim maintenance I therapy).

LOW-RISK: Patients are randomized to 1 of 2 treatment arms.

Arm I (LR-M): Consolidation therapy (19 weeks): Beginning one week after completion of induction therapy, patients receive vincristine sulfate IV on days 15, 22, 78, and 85; methotrexate IV over 24 hours and IT methotrexate on days 8, 29, 50, 71, 92, and 113; leucovorin calcium PO or IV on days 9-10, 30-31, 51-52, 72-73, 93-94, and 114-115; dexamethasone PO BID or IV on days 15-21 and 78-84; and PO mercaptopurine on days 1-133.Maintenance therapy: Patients receive vincristine sulfate IV on days 1 and 8; dexamethasone PO BID on days 1-7; methotrexate* PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, and 106; and mercaptopurine PO on days 1-112. Courses repeat every 16 weeks. Patients also receive IT methotrexate on days 1 and 85 (courses 1 and 4), day 57 (courses 2 and 5), or day 29 (courses 3 and 6). Patients then receive course 7 comprising vincristine sulfate IV on days 1 and 8; dexamethasone PO BID on days 1-7; methotrexate PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64; and mercaptopurine PO on days 1-70. Treatment continues for 2 and ½ years (timed from the date of diagnosis).NOTE: *Patients do not receive methotrexate PO on the days that they receive IT methotrexate.

Arm II (LR-C): Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; oral mercaptopurine on days 1-28; and IT methotrexate on days 1, 8, and 15. Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on day 31. Delayed-intensification therapy (8 weeks): Patients receive dexamethasone PO or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO on days 29-42; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; and IT methotrexate on days 1 and 29.Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on days 1 and 31. Maintenance therapy: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Courses repeat every 12 weeks for 2 years for girls and for 3 years for boys (timed from the start of interim maintenance I therapy).

After completion of study treatment, patients are followed up periodically for 10 years.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Childrens Oncology Group

Principal Investigator
Anne Lisette Angiolillo

Trial IDs

Primary ID AALL0932
Secondary IDs NCI-2011-02599, CDR0000683227
Clinicaltrials.gov ID NCT01190930