Chemotherapy showdown: which combo works best for T-Cell cancers in kids?

NCT ID NCT00408005

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This large phase 3 trial studied nearly 1,900 children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Researchers compared different chemotherapy combinations, including varying doses of methotrexate and adding the drug nelarabine, to see which improved disease-free survival. Participants were assigned to treatment arms based on their risk level, and the study tracked outcomes like relapse and death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: combination chemotherapy (methotrexate, nelarabine, asparaginase, cyclophosphamide, and others)
What this could lead to: If successful, this could establish a more effective chemotherapy regimen for children and young adults with T-cell leukemia or lymphoma, potentially improving long-term survival rates.
What could go wrong: This is a completed phase 3 trial, but results may not apply to all patients. Chemotherapy has significant side effects, and the optimal regimen may still depend on individual risk factors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,895 people

The number who actually took part.

Started

Jan 2007

Finished

Mar 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 30 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * T-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0434 * Patients must have newly diagnosed T-ALL or T-lineage lymphoblastic lymphoma (T-NHL) stage II-IV; B-lineage lymphoblastic lymphoma will not be eligible for this study; 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; if surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including transmission disequilibrium test (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 * T-NHL PATIENTS: * For T-NHL 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-NHL defined by the submitting institution will be accepted * Prior therapy restrictions * Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and/or IT cytarabine * IT chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (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); systemic chemotherapy must begin within 72 hours of this IT therapy * Patients diagnosed as having T-NHL or T-ALL with respiratory distress or hyperleukocytosis may require steroids prior to the initiation of additional systemic therapy; they are eligible for AALL0434 and will be stratified, based on the initial complete blood count (CBC); steroid pretreatment may alter the risk group assessment; if the T-ALL patient's clinical status precludes a lumbar puncture within 48 hours of the initiation of steroid therapy, T-ALL patients CANNOT be classified as low risk and will be Intermediate or high risk based on the results of the day 29 marrow as above; patients with T-NHL who receive steroid pre-treatment will be classified as high risk; the dose and duration of previous steroid therapy should be carefully documented * For the management of airway compromise, patients who have received emergent chest irradiation up to 600 cGy will be eligible for this study * Patients with a prior seizure disorder requiring anti-convulsant therapy are not eligible to receive nelarabine; in addition, patients with pre-existing grade 2 (or greater) peripheral neurotoxicity, as determined prior to Induction treatment by the treating physician or a neurologist, are not eligible to receive nelarabine; these restrictions in eligibility are designed to prevent excessive nelarabine-induced central and peripheral neurotoxicity in at-risk patients; for the purposes of this study, this includes any patient that has received anticonvulsant therapy to prevent/treat seizures in the prior two years Exclusion Criteria: * Pregnant or lactating females are ineligible * Patients with Down syndrome are ineligible to enroll onto this study * For T-NHL patients the following additional exclusion criteria apply: * B-precursor lymphoblastic lymphoma * Morphologically unclassifiable lymphoma * Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma * CNS3-positive or testicular involvement

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma T-cell acute lymphoblastic leukemia T-cell childhood acute lymphocytic leukemia T-lymphoblastic lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

T acute lymphoblastic leukemia T lymphoblastic lymphoma

Contacts and locations

Locations

AdventHealth Orlando

Orlando, Florida, 32803, United States
Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, 60453, United States
Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, 60068, United States
Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States
Albany Medical Center

Albany, New York, 12208, United States
Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada
Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States
Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135, United States
Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States
Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States
Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States
Augusta University Medical Center

Augusta, Georgia, 30912, United States
BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605, United States
Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States
Baystate Medical Center

Springfield, Massachusetts, 01199, United States
Blank Children's Hospital

Des Moines, Iowa, 50309, United States
British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada
Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States
Brooklyn Hospital Center

Brooklyn, New York, 11201, United States
Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States
C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States
CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada
Carilion Children's

Roanoke, Virginia, 24014, United States
Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States
Cedars Sinai Medical Center

Los Angeles, California, 90048, United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, 30329, United States
Children's Hospital

London, Ontario, N6A 5W9, Canada
Children's Hospital Colorado

Aurora, Colorado, 80045, United States
Children's Hospital Los Angeles

Los Angeles, California, 90027, United States
Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States
Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States
Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114, United States
Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States
Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada
Children's Hospital of Orange County

Orange, California, 92868, United States
Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States
Children's Hospital of San Antonio

San Antonio, Texas, 78207, United States
Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507, United States
Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States
Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States
Children's National Medical Center

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

Christchurch, 8011, New Zealand
Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States
City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States
Cook Children's Medical Center

Fort Worth, Texas, 76104, United States
Corewell Health Children's

Royal Oak, Michigan, 48073, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States
Covenant Children's Hospital

Lubbock, Texas, 79410, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States
Dayton Children's Hospital

Dayton, Ohio, 45404, United States
Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States
Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
East Carolina University

Greenville, North Carolina, 27834, United States
East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916, United States
Eastern Maine Medical Center

Bangor, Maine, 04401, United States
Geisinger Medical Center

Danville, Pennsylvania, 17822, United States
Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States
Greenville Cancer Treatment Center

Greenville, South Carolina, 29605, United States
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236, United States
Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada
Hurley Medical Center

Flint, Michigan, 48503, United States
IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada
Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States
Janeway Child Health Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States
Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States
Kaiser Permanente Downey Medical Center

Downey, California, 90242, United States
Kaiser Permanente-Oakland

Oakland, California, 94611, United States
Kalamazoo Center for Medical Studies

Kalamazoo, Michigan, 49008, United States
Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States
Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada
Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States
Lee Memorial Health System

Fort Myers, Florida, 33901, United States
Legacy Emanuel Children's Hospital

Portland, Oregon, 97227, United States
Legacy Emanuel Hospital and Health Center

Portland, Oregon, 97227, United States
Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States
Loma Linda University Medical Center

Loma Linda, California, 92354, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502, United States
Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611, United States
Madigan Army Medical Center

Tacoma, Washington, 98431, United States
Maine Children's Cancer Program

Scarborough, Maine, 04074, United States
Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States
Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405, United States
Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States
Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States
MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States
Medical City Dallas Hospital

Dallas, Texas, 75230, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Memorial Health University Medical Center

Savannah, Georgia, 31404, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States
Mercy Children's Hospital

Toledo, Ohio, 43608, United States
Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States
Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229, United States
Miami Cancer Institute

Miami, Florida, 33176, United States
Michigan State University Clinical Center

East Lansing, Michigan, 48824, United States
Miller Children's and Women's Hospital Long Beach

Long Beach, California, 90806, United States
Mission Hospital

Asheville, North Carolina, 28801, United States
Monash Medical Center-Clayton Campus

Clayton, Victoria, 3168, Australia
Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States
Morristown Medical Center

Morristown, New Jersey, 07960, United States
Mount Sinai Hospital

New York, New York, 10029, United States
NYP/Weill Cornell Medical Center

New York, New York, 10065, United States
NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States
Natalie Warren Bryant Cancer Center at Saint Francis

Tulsa, Oklahoma, 74136, United States
Nationwide Children's Hospital

Columbus, Ohio, 43205, United States
Nemours Children's Clinic - Orlando

Orlando, Florida, 32806, United States
Nemours Children's Clinic - Pensacola

Pensacola, Florida, 32504, United States
Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207, United States
Nemours Children's Hospital

Orlando, Florida, 32827, United States
Nevada Cancer Research Foundation NCORP

Las Vegas, Nevada, 89169, United States
New York Medical College

Valhalla, New York, 10595, United States
Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States
Nicklaus Children's Hospital

Miami, Florida, 33155, United States
Norton Children's Hospital

Louisville, Kentucky, 40202, United States
Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States
Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States
Oregon Health and Science University

Portland, Oregon, 97239, United States
Orlando Health Cancer Institute

Orlando, Florida, 32806, United States
Overlook Hospital

Summit, New Jersey, 07902, United States
Penn State Children's Hospital

Hershey, Pennsylvania, 17033, United States
Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States
Primary Children's Hospital

Salt Lake City, Utah, 84113, United States
Princess Margaret Hospital for Children

Perth, Western Australia, 6008, Australia
Prisma Health Richland Hospital

Columbia, South Carolina, 29203, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606, United States
Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204, United States
Queensland Children's Hospital

South Brisbane, Queensland, 4101, Australia
Rady Children's Hospital - San Diego

San Diego, California, 92123, United States
Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106, United States
Riley Hospital for Children

Indianapolis, Indiana, 46202, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, 80218, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia
Royal Children's Hospital

Parkville, Victoria, 3052, Australia
Royal Children's Hospital-Brisbane

Herston, Queensland, 4029, Australia
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States
Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States
Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States
Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, 33607, United States
Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503, United States
Saint Jude Midwest Affiliate

Peoria, Illinois, 61637, United States
Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States
Saint Mary's Medical Center

West Palm Beach, Florida, 33407, United States
Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States
Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States
Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States
Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States
Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada
Scott and White Memorial Hospital

Temple, Texas, 76508, United States
Seattle Children's Hospital

Seattle, Washington, 98105, United States
Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States
Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States
Starship Children's Hospital

Grafton, Auckland, 1145, New Zealand
State University of New York Upstate Medical University

Syracuse, New York, 13210, United States
Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144, United States
Sutter Medical Center Sacramento

Sacramento, California, 95816, United States
Swiss Pediatric Oncology Group - Geneva

Geneva, 1205, Switzerland
Swiss Pediatric Oncology Group - Lausanne

Lausanne, 1011, Switzerland
T C Thompson Children's Hospital

Chattanooga, Tennessee, 37403, United States
Texas Tech University Health Sciences Center-Amarillo

Amarillo, Texas, 79106, United States
The Montreal Children's Hospital of the MUHC

Montreal, Quebec, H3H 1P3, Canada
The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States
Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States
Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States
UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States
UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States
UCSF Medical Center-Parnassus

San Francisco, California, 94143, United States
UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
USA Health Strada Patient Care Center

Mobile, Alabama, 36604, United States
UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States
University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States
University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada
University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States
University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610, United States
University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States
University of Illinois

Chicago, Illinois, 60612, United States
University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States
University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States
University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States
University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States
University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States
University of Missouri Children's Hospital

Columbia, Missouri, 65212, United States
University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States
University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Rochester

Rochester, New York, 14642, United States
University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States
University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States
University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States
University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States
Valley Children's Hospital

Madera, California, 93636, United States
Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States
Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States
Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States
Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
West Virginia University Charleston Division

Charleston, West Virginia, 25304, United States
Women's and Children's Hospital-Adelaide

North Adelaide, South Australia, 5006, Australia
Yale University

New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.