Combination Chemotherapy with or without Bortezomib in Treating Younger Patients with Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest
Status: Temporarily Closed to Accrual

Description

This randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.

Eligibility Criteria

Inclusion Criteria

  • T-ALL: T-ALL patients must be enrolled on AALL08B1 or Project:EveryChild (APEC14B1, if open for the classification of ALL patients) prior to treatment and enrollment on AALL1231
  • Patients must have newly diagnosed T-lymphoblastic leukemia (T-ALL) or T-lymphoblastic lymphoma (T-LLy) stages II-IV * Note: a diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (cluster of differentiation [CD]19/CD22/CD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a, and are present either in peripheral blood or > 25% in the bone marrow; if surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including terminal deoxynucleotidyl transferase (TdT), CD34 or CD99 will be assessed for expression; cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory * For T-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of T-LLy defined by the submitting institution will be accepted
  • All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines

Exclusion Criteria

  • Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of T-ALL, T-L-Ly or for any cancer diagnosis prior to the initiation of protocol therapy on AALL1231, with the exception of: * Steroid pretreatment: prednisone or methylprednisolone for =< 120 hours (5 days) in the 7 days prior to initiating induction chemotherapy or for =< 336 hours (14 days) in the 28 days prior to initiating induction chemotherapy; prior exposure to ANY steroids that occurred > 28 days before the initiation of protocol therapy does not affect eligibility; the dose of prednisone or methylprednisolone does not affect eligibility * Intrathecal cytarabine (the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) system chemotherapy must begin with 72 hours of this IT therapy; or * 600 cGy of chest irradiation, if medically necessary ** Pre-treatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone use during sedation to prevent or treat airway edema; inhalation steroids and topical steroids are not considered pretreatment
  • Pre-existing >= grade 2 sensory or motor peripheral neurotoxicity
  • Uncontrolled seizure disorder
  • Diagnosis of Down syndrome (Trisomy 21)
  • Patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
  • Lactating females who plan to breastfeed
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
  • Patient has hypersensitivity to bortezomib, boron, or mannitol
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and within 30 days of any dose of bortezomib

Locations & Contacts

Alabama

Birmingham
Children's Hospital of Alabama
Status: Temporarily closed to accrual
Contact: Alyssa Terry Reddy Email: helpdesk@childrensoncologygroup.org
Mobile
University of South Alabama
Status: Temporarily closed to accrual
Contact: Felicia Little Wilson
Phone: 251-665-8000

Alaska

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

Arizona

Mesa
Cardon Children's Medical Center
Status: Temporarily closed to accrual
Contact: Erlyn C. Smith Email: helpdesk@childrensoncologygroup.org
Phoenix
Phoenix Childrens Hospital
Status: Temporarily closed to accrual
Contact: Jessica Boklan
Phone: 602-546-0920
Tucson
The University of Arizona Medical Center-University Campus
Status: Temporarily closed to accrual
Contact: Neha Bhasin
Phone: 520-626-9008

Arkansas

Little Rock
Arkansas Children's Hospital
Status: Temporarily closed to accrual
Contact: David L. Becton
Phone: 501-686-8274

California

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

Colorado

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

Connecticut

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

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: Temporarily closed to accrual
Contact: Evangeline J. Brown Email: helpdesk@childrensoncologygroup.org

District of Columbia

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

Florida

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

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: Temporarily closed to accrual
Contact: Himalee Shreekant Sabnis Email: helpdesk@childrensoncologygroup.org
Augusta
Augusta University Medical Center
Status: Temporarily closed to accrual
Contact: Colleen H. McDonough
Phone: 706-721-1663 Email: cancer@augusta.edu
Savannah
Memorial University Medical Center
Status: Temporarily closed to accrual
Contact: Andrew L. Pendleton
Phone: 912-350-8568

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: Temporarily closed to accrual
Contact: Wade T. Kyono
Phone: 808-586-2979

Idaho

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

Illinois

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

Indiana

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

Iowa

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

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Temporarily closed to accrual
Contact: Lars Martin Wagner
Phone: 859-257-3379
Louisville
Norton Children's Hospital
Status: Temporarily closed to accrual
Contact: Ashok B. Raj
Phone: 502-562-3429

Louisiana

New Orleans
Children's Hospital New Orleans
Status: Temporarily closed to accrual
Contact: Lolie C. Yu Email: helpdesk@childrensoncologygroup.org
Ochsner Medical Center Jefferson
Status: Temporarily closed to accrual
Contact: Craig Lotterman
Phone: 504-842-3708

Maine

Bangor
Eastern Maine Medical Center
Status: Temporarily closed to accrual
Contact: Sam Wei Lew
Phone: 207-973-4274
Scarborough
Maine Children's Cancer Program
Status: Temporarily closed to accrual
Contact: Aaron Robert Weiss Email: helpdesk@childrensoncologygroup.org

Maryland

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

Massachusetts

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

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: Temporarily closed to accrual
Contact: Rajen Mody Email: helpdesk@childrensoncologygroup.org
Detroit
Saint John Hospital and Medical Center
Status: Temporarily closed to accrual
Contact: Adonis N. Lorenzana
Phone: 313-343-3166
Wayne State University / Karmanos Cancer Institute
Status: Temporarily closed to accrual
Contact: Meret Henry
Phone: 313-576-9363
East Lansing
Michigan State University Clinical Center
Status: Temporarily closed to accrual
Contact: Renuka Gera
Phone: 517-975-9547
Flint
Hurley Medical Center
Status: Temporarily closed to accrual
Contact: Nkechi Onwuzurike
Phone: 810-762-8057
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: Temporarily closed to accrual
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Spectrum Health at Butterworth Campus
Status: Temporarily closed to accrual
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Kalamazoo
Bronson Methodist Hospital
Status: Temporarily closed to accrual
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
West Michigan Cancer Center
Status: Temporarily closed to accrual
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Royal Oak
Beaumont Children's Hospital-Royal Oak
Status: Temporarily closed to accrual
Contact: Laura Kate Gowans
Phone: 248-551-7695

Minnesota

Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Status: Temporarily closed to accrual
Contact: Michael Kerr Richards Email: helpdesk@childrensoncologygroup.org
University of Minnesota / Masonic Cancer Center
Status: Temporarily closed to accrual
Contact: Peter Michael Gordon
Phone: 877-442-3324
Rochester
Mayo Clinic
Status: Temporarily closed to accrual
Contact: Carola A. S. Arndt
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: Temporarily closed to accrual
Contact: Gail Cranshaw Megason
Phone: 601-815-6700

Missouri

Columbia
Columbia Regional
Status: Temporarily closed to accrual
Contact: Barbara Anne Gruner Email: helpdesk@childrensoncologygroup.org
Kansas City
The Childrens Mercy Hospital
Status: Temporarily closed to accrual
Contact: Keith Jason August
Phone: 888-823-5923 Email: ctsucontact@westat.com
Saint Louis
Cardinal Glennon Children's Medical Center
Status: Temporarily closed to accrual
Contact: William Shay Ferguson Email: helpdesk@childrensoncologygroup.org
Mercy Hospital Saint Louis
Status: Temporarily closed to accrual
Contact: Bethany Graham Sleckman
Phone: 800-600-3606 Email: info@siteman.wustl.edu
Washington University School of Medicine
Status: Temporarily closed to accrual
Contact: Robert J. Hayashi
Phone: 800-600-3606 Email: info@siteman.wustl.edu

Nebraska

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

Nevada

Las Vegas
Children's Specialty Center of Nevada II
Status: Temporarily closed to accrual
Contact: Alan K. Ikeda
Phone: 702-384-0013
Nevada Cancer Research Foundation CCOP
Status: Active
Contact: Nik Farahana Nik Abdul Rashid
Phone: 702-384-0013
Summerlin Hospital Medical Center
Status: Temporarily closed to accrual
Contact: Alan K. Ikeda
Phone: 702-384-0013
Sunrise Hospital and Medical Center
Status: Temporarily closed to accrual
Contact: Alan K. Ikeda
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: Temporarily closed to accrual
Contact: Alan K. Ikeda
Phone: 702-384-0013

New Hampshire

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

New Jersey

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

New Mexico

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

New York

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

North Carolina

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

North Dakota

Fargo
Sanford Broadway Medical Center
Status: Temporarily closed to accrual
Contact: Samuel Odame Anim
Phone: 800-437-4010

Ohio

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

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Temporarily closed to accrual
Contact: Rene Yvonne McNall-Knapp
Phone: 405-271-8777 Email: ou-clinical-trials@ouhsc.edu

Oregon

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

Pennsylvania

Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: Temporarily closed to accrual
Contact: Lydia Alberta Boateng
Phone: 484-884-2201
Danville
Geisinger Medical Center
Status: Temporarily closed to accrual
Contact: Jagadeesh Ramdas
Phone: 570-271-5251
Hershey
Penn State Children's Hospital
Status: Temporarily closed to accrual
Contact: Lisa MacNabb McGregor Email: helpdesk@childrensoncologygroup.org
Philadelphia
Children's Hospital of Philadelphia
Status: Temporarily closed to accrual
Contact: David Trent Teachey Email: helpdesk@childrensoncologygroup.org
Saint Christopher's Hospital for Children
Status: Temporarily closed to accrual
Contact: Gregory Emmett Halligan Email: helpdesk@childrensoncologygroup.org
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: Temporarily closed to accrual
Contact: Jean M. Tersak Email: helpdesk@childrensoncologygroup.org

South Carolina

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

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: Temporarily closed to accrual
Contact: Kayelyn Jean Wagner
Phone: 605-328-1367

Tennessee

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

Texas

Austin
Dell Children's Medical Center of Central Texas
Status: Temporarily closed to accrual
Contact: Amy Catherine Fowler Email: helpdesk@childrensoncologygroup.org
Corpus Christi
Driscoll Children's Hospital
Status: Temporarily closed to accrual
Contact: Nkechi Ifeoma Mba Email: helpdesk@childrensoncologygroup.org
Dallas
Medical City Dallas Hospital
Status: Temporarily closed to accrual
Contact: Stanton Carl Goldman
Phone: 972-566-5588
UT Southwestern / Simmons Cancer Center-Dallas
Status: Temporarily closed to accrual
Contact: Tamra Lynn Slone
Phone: 214-648-7097
El Paso
El Paso Children's Hospital
Status: Temporarily closed to accrual
Contact: Lisa Louise Rubin Hartman Email: helpdesk@childrensoncologygroup.org
Fort Worth
Cook Children's Medical Center
Status: Temporarily closed to accrual
Contact: Kenneth Matthew Heym Email: helpdesk@childrensoncologygroup.org
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Eric Stephen Schafer
Phone: 410-955-8804 Email: jhcccro@jhmi.edu
M D Anderson Cancer Center
Status: Temporarily closed to accrual
Contact: Najat C. Daw
Phone: 713-792-3245
Lubbock
Covenant Children's Hospital
Status: Temporarily closed to accrual
Contact: Kishor Mallikarjun Bhende
Phone: 806-775-8590
University Medical Center
Status: Temporarily closed to accrual
Contact: Mohamad M. Al-Rahawan
Phone: 309-655-3258
San Antonio
Children's Hospital of San Antonio
Status: Temporarily closed to accrual
Contact: Timothy C. Griffin
Phone: 800-248-1199
Methodist Children's Hospital of South Texas
Status: Temporarily closed to accrual
Contact: Vinod Kumar Gidvani-Diaz Email: helpdesk@childrensoncologygroup.org
University of Texas Health Science Center at San Antonio
Status: Temporarily closed to accrual
Contact: Anne-Marie R. Langevin
Phone: 210-450-3800 Email: CTO@uthscsa.edu

Utah

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

Vermont

Burlington
University of Vermont College of Medicine
Status: Temporarily closed to accrual
Contact: Alan Charles Homans
Phone: 802-656-8990

Virginia

Charlottesville
University of Virginia Cancer Center
Status: Temporarily closed to accrual
Contact: William Carl Petersen
Phone: 434-243-6322 Email: JME3D@hscmail.mcc.virginia.edu
Falls Church
Inova Fairfax Hospital
Status: Temporarily closed to accrual
Contact: Marshall A. Schorin
Phone: 703-208-6650 Email: Stephanie.VanBebber@inova.org
Norfolk
Childrens Hospital-King's Daughters
Status: Temporarily closed to accrual
Contact: Eric Jeffrey Lowe Email: helpdesk@childrensoncologygroup.org
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: Temporarily closed to accrual
Contact: Christina Marie Wiedl Email: helpdesk@childrensoncologygroup.org
Roanoke
Carilion Clinic Children's Hospital
Status: Temporarily closed to accrual
Contact: Mandy M Atkinson Email: helpdesk@childrensoncologygroup.org

Washington

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

West Virginia

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

Wisconsin

Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: Temporarily closed to accrual
Contact: John Robert Hill
Phone: 920-433-8889 Email: Christy.Gilchrist@hshs.org
Madison
University of Wisconsin Hospital and Clinics
Status: Temporarily closed to accrual
Contact: Kenneth Brian De Santes
Phone: 800-622-8922
Marshfield
Marshfield Clinic
Status: Temporarily closed to accrual
Contact: Michael John McManus
Phone: 800-782-8581
Milwaukee
Children's Hospital of Wisconsin
Status: Temporarily closed to accrual
Contact: Michael James Burke
Phone: 414-955-4727 Email: MACCCTO@mcw.edu

Alberta

Calgary
Alberta Children's Hospital
Status: Temporarily closed to accrual
Contact: Douglas R. Strother Email: helpdesk@childrensoncologygroup.org
Edmonton
University of Alberta Hospital
Status: Temporarily closed to accrual
Contact: Sarah Jane McKillop
Phone: 780-407-6615 Email: val.taylor@albertahealthservices.ca

British Columbia

Vancouver
British Columbia Children's Hospital
Status: Temporarily closed to accrual
Contact: David Bryan Dix Email: helpdesk@childrensoncologygroup.org

Manitoba

Winnipeg
CancerCare Manitoba
Status: Temporarily closed to accrual
Contact: Tanya Renae Brown
Phone: 866-561-1026 Email: CIO_Web@cancercare.mb.ca

Newfoundland and Labrador

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

Nova Scotia

Halifax
IWK Health Centre
Status: Temporarily closed to accrual
Contact: Conrad Vincent Fernandez
Phone: 902-470-8394

Ontario

Hamilton
McMaster Children's Hospital at Hamilton Health Sciences
Status: Temporarily closed to accrual
Contact: Carol Portwine Email: helpdesk@childrensoncologygroup.org
Kingston
Kingston Health Sciences Centre
Status: Temporarily closed to accrual
Contact: Mariana Pradier Silva
Phone: 613-549-6666 Email: cc-clinicaltrials@kgh.kari.net
London
Children's Hospital
Status: Temporarily closed to accrual
Contact: Shayna M. Zelcer Email: helpdesk@childrensoncologygroup.org
Ottawa
Children's Hospital of Eastern Ontario
Status: Temporarily closed to accrual
Contact: Donna Lynn Johnston Email: helpdesk@childrensoncologygroup.org
Toronto
Hospital for Sick Children
Status: Temporarily closed to accrual
Contact: Oussama Amine Abla
Phone: 416-813-7654ext2027 Email: jason.mcguire@sickkids.ca

Quebec

Montreal
Centre Hospitalier Universitaire Sainte-Justine
Status: Temporarily closed to accrual
Contact: Yvan Samson
Phone: 514-345-4931
The Montreal Children's Hospital of the MUHC
Status: Temporarily closed to accrual
Contact: Yvan Samson Email: helpdesk@childrensoncologygroup.org

Saskatchewan

Saskatoon
Saskatoon Cancer Centre
Status: Temporarily closed to accrual
Contact: Christopher Mpofu
Phone: 306-655-2914

Australia

Clayton
Monash Medical Center-Clayton Campus
Status: Temporarily closed to accrual
Contact: Paul James Wood
Phone: (03) 9928 8111
Hunter Regional Mail Centre
John Hunter Children's Hospital
Status: Temporarily closed to accrual
Contact: Francoise Marie Mechinaud Email: helpdesk@childrensoncologygroup.org
North Adelaide
Women's and Children's Hospital-Adelaide
Status: Temporarily closed to accrual
Contact: Maria Louise Kirby Email: helpdesk@childrensoncologygroup.org
Parkville
Royal Children's Hospital
Status: Temporarily closed to accrual
Contact: Jordan R. Hansford Email: helpdesk@childrensoncologygroup.org
Perth
Princess Margaret Hospital for Children
Status: Temporarily closed to accrual
Contact: Marianne Barnetson Phillips
Phone: (08) 9340 8222 Email: catherine.cole@health.wa.gov.au
South Brisbane
Lady Cilento Children's Hospital
Status: Temporarily closed to accrual
Contact: Francoise Marie Mechinaud Email: helpdesk@childrensoncologygroup.org
Westmead
The Children's Hospital at Westmead
Status: Temporarily closed to accrual
Contact: Geoffrey Brian McCowage
Phone: (02) 9845 8183

New Zealand

Christchurch
Christchurch Hospital
Status: Temporarily closed to accrual
Contact: Siobhan Frances Cross
Phone: 03 364 0640
Grafton
Starship Children's Hospital
Status: Temporarily closed to accrual
Contact: Peter James Bradbeer Email: helpdesk@childrensoncologygroup.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To compare event-free survival (EFS) in patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LLy) who are randomized to a modified augmented Berlin-Frankfurt-Münster (ABFM) backbone versus bortezomib plus the modified ABFM backbone.

SECONDARY OBJECTIVES:

I. To determine the safety and feasibility of modifying standard therapy for T-ALL and T-LLy based on the results of UKALL 2003, which includes a dexamethasone-based induction, additional doses of pegaspargase (PEG-ASP) during induction and delayed intensification (DI), and dexamethasone pulses during maintenance therapy.

II. To determine if prophylactic (presymptomatic) cranial radiation therapy (CRT) can be safely and effectively eliminated in the 85-90% of T-ALL patients classified as standard or intermediate risk.

III. To determine the proportion of end of consolidation (EOC) minimal residual disease (MRD) >= 0.1% T-ALL patients who become MRD negative (undetectable by flow cytometry) after intensification of chemotherapy, using three high risk (HR) BFM blocks, and to compare EFS between the patients who become MRD negative after the three HR BFM blocks and continue on chemotherapy with those who continue to have detectable MRD and are eligible for other treatment strategies, including hematopoietic stem cell transplant (HSCT). Similarly, to compare the EFS between very high risk (induction failure) T-LLy patients treated with HR BFM intensification blocks who have partial or complete response (PR or CR) with those who do not respond (NR).

TERTIARY OBJECTIVES:

I. To investigate the prognostic significance of day 29 bone marrow (BM) MRD in T-LLy patients.

II. To determine if protein expression patterns can predict bortezomib response and drug resistance in T-ALL.

III. To analyze and target relevant signaling pathways in T-ALL blasts, focusing on early T cell precursor (ETP) acute lymphoblastic leukemia (ALL).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

INDUCTION ARM A: Patients receive cytarabine intrathecally (IT) at time of diagnostic lumbar puncture (if within 72 hours from start of protocol therapy) OR day 1; vincristine sulfate intravenously (IV) over 1 minute on days 1, 8, 15, and 22; dexamethasone orally (PO) twice daily (BID) on days 1-28 (no taper); daunorubicin hydrochloride IV over 1-15 minutes on days 1, 8, 15, and 22; pegaspargase IV over 1-2 hours on days 4 and 18; and methotrexate IT on days 8 and 29 (and on days 15 and 22 for central nervous system 3 involvement [CNS3] T-ALL patients).

INDUCTION ARM B: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11; and cytarabine, vincristine sulfate, dexamethasone, daunorubicin hydrochloride, pegaspargase, and methotrexate as in Induction Arm A.

CONSOLIDATION: Beginning on day 36 from Induction, patients receive methotrexate IT on days 1, 8, 15, and 22 (days 1 and 8 only for CNS3 T-ALL or CNS3 T-LLy patients); cyclophosphamide IV over 30-60 minutes on days 1 and 29; cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO once daily (QD) on days 1-14 and 29-42; pegaspargase IV over 1-2 hours on days 15 and 43; and vincristine sulfate IV on days 15, 22, 43, and 50. Patients with persistent testicular disease undergo radiation therapy.

Patients are then assigned to subsequent therapy according to risk assignment. Patients with standard risk (SR) disease receive Interim Maintenance with Capizzi methotrexate (CMTX); patients with intermediate risk (IR) disease receive Interim Maintenance with high-dose methotrexate (HDMTX), Delayed Intensification, and then Interim Maintenance with CMTX; and patients with very high risk (VHR) disease receive 3 HR Intensification Blocks, Delayed Intensification, and then Interim Maintenance with CMTX.

CMTX INTERIM MAINTENANCE: Patients receive vincristine sulfate IV over 1 minute on days 1, 11, 21, 31, and 41; methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes (diluted) on days 1, 11, 21, 31, and 41; pegaspargase IV over 1-2 hours on days 2 and 22; and methotrexate IT on days 1 and 31. The next course (based on risk assignment) begins on day 57 or when blood counts recover (whichever occurs later).

DELAYED INTENSIFICATION ARM A: Patients receive vincristine sulfate IV over 1 minute on days 1, 8, 15, 43, and 50; dexamethasone PO BID or IV on days 1-7 and 15-21; doxorubicin hydrochloride IV over 15 minutes on days, 1, 8, and 15; pegaspargase IV over 1-2 hours on days 4, 18, and 43; methotrexate IT on days 1, 29, and 36; cyclophosphamide IV over 30-60 minutes on day 29; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; and thioguanine PO on days 29-42. The next course (based on risk assignment) begins on day 64 or when blood counts recover (whichever occurs later).

DELAYED INTENSIFICATION ARM B: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 15, and 18; and vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, methotrexate, cyclophosphamide, cytarabine, and thioguanine as in Delayed Intensification Arm A. The next course (based on risk assignment) begins on day 64 or when blood counts recover (whichever occurs later).

HDMTX INTERIM MAINTENANCE: Patients receive high-dose methotrexate IV over 24 hours on days 1, 15, 29, and 43; leucovorin calcium IV or PO on days 3-4, 17-18, 31-32, and 45-46; vincristine sulfate IV on days 1, 15, 29, and 43; mercaptopurine PO QD on days 1-56; and methotrexate IT on days 1 and 29. The next course (based on randomization assignment) begins on day 57 or when blood counts recover (whichever occurs later).

INTENSIFICATION BLOCK I: Patients receive dexamethasone IV or PO BID on days 1-5; high-dose methotrexate IV over 24 hours on day 1; leucovorin calcium IV or PO on days 3-4; vincristine sulfate IV on days 1 and 6; cyclophosphamide IV over 1-6 hours on days 2-4; high-dose cytarabine IV over 3 hours every 12 hours on day 5; pegaspargase IV over 1-2 hours on day 6; and triple IT therapy comprising methotrexate IT, hydrocortisone IT, and cytarabine IT on day 1. The next course (Intensification Block II) begins on day 22 or when blood counts recover (whichever occurs later).

INTENSIFICATION BLOCK II: Patients receive dexamethasone PO BID or IV on days 1-5; high-dose methotrexate IV over 24 hours on day 1; leucovorin calcium PO or IV on days 3-4; vincristine sulfate IV on days 1 and 6; ifosfamide IV over 1 hour every 12 hours on days 2-4; daunorubicin hydrochloride IV over 30 minutes on day 5; pegaspargase IV over 1-2 hours on day 6; and triple IT therapy on day 1 as in Intensification Block I. The next course (Intensification Block III) begins on day 22 or when blood counts recover (whichever occurs later).

INTENSIFICATION BLOCK III: Patients receive dexamethasone PO BID or IV on days 1-5; high-dose cytarabine IV over 3 hours every 12 hours on days 1-2; etoposide IV over 1-2 hours every 12 hours on days 3-5; pegaspargase IV over 1-2 hours on day 6; and triple IT therapy on day 5 as in Intensification Block I. The next course (based on randomization) begins on day 22 or when blood counts recover (whichever occurs later).

MAINTENANCE THERAPY: All patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61; mercaptopurine PO on days 1-84; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 (omit day 29 for SR patients during the first 4 courses); methotrexate IT on day 1 (and day 29 during the first 4 courses for SR patients and during the first 2 courses for IR patients). Patients with CNS3 IR disease also undergo cranial radiation therapy during the first 4 weeks (course 1). Treatment in female patients with T-ALL and patients with T-LLY repeats every 12 weeks for up to 2 years from the start of Interim Maintenance (week 119). Treatment in male patients with T-ALL repeats every 12 weeks for up to 3 years from the start of Interim Maintenance (week 171).

All treatment continues in the absence of disease progression or unacceptable toxicity.

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

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Childrens Oncology Group

Principal Investigator
David Trent Teachey

Trial IDs

Primary ID AALL1231
Secondary IDs NCI-2014-00712, s14-01925
Clinicaltrials.gov ID NCT02112916