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NCT00408005CompletedPhase 3

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Intensified Methotrexate, Nelarabine (Compound 506U78) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma

Source: ClinicalTrials.gov · Last updated 23 Jun 2026

Brief summary (registry, in English)

This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. After a common induction therapy, patients were risk assigned and eligible for one or both post-induction randomizations: Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High Risk and induction failures. Standard risk patients did not receive nelarabine, High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures were assigned to receive Nelarabine.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1895 (actual)
First submitted
4 Dec 2006
Start date
30 Jan 2007
Primary completion date
30 Sept 2017
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT00408005

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1895
  • From 30 Jan 2007 to the primary completion date, 30 Sept 2017
  • 215 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with Down syndrome are ineligible to enroll onto this study

Other

  • Pregnant or lactating females are ineligible
  • 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

Who the study is looking for

  • 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

Age in the registry: 1 year to 30 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (215)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Monash Medical Center-Clayton Campus
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ClaytonAustraliaUnknown status
Royal Brisbane and Women's Hospital
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HerstonAustraliaUnknown status
Royal Children's Hospital-Brisbane
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HerstonAustraliaUnknown status
Women's and Children's Hospital-Adelaide
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North AdelaideAustraliaUnknown status
Royal Children's Hospital
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ParkvilleAustraliaUnknown status
Princess Margaret Hospital for Children
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PerthAustraliaUnknown status
Queensland Children's Hospital
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South BrisbaneAustraliaUnknown status
Alberta Children's Hospital
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CalgaryCanadaUnknown status
University of Alberta Hospital
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EdmontonCanadaUnknown status
IWK Health Centre
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HalifaxCanadaUnknown status
Kingston Health Sciences Centre
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KingstonCanadaUnknown status
Children's Hospital
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LondonCanadaUnknown status
The Montreal Children's Hospital of the MUHC
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MontrealCanadaUnknown status
Children'S Hospital Of Eastern Ontario
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OttawaCanadaUnknown status
Allan Blair Cancer Centre
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ReginaCanadaUnknown status
Saskatoon Cancer Centre
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SaskatoonCanadaUnknown status
Janeway Child Health Centre
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St. John'sCanadaUnknown status
Hospital for Sick Children
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TorontoCanadaUnknown status
British Columbia Children's Hospital
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VancouverCanadaUnknown status
CancerCare Manitoba
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WinnipegCanadaUnknown status
Swiss Pediatric Oncology Group - Geneva
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GenevaSwitzerlandUnknown status
Swiss Pediatric Oncology Group - Lausanne
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LausanneSwitzerlandUnknown status
Christchurch Hospital
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ChristchurchNew ZealandUnknown status
Starship Children's Hospital
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GraftonNew ZealandUnknown status
Children's Hospital Medical Center of Akron
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AkronUnited StatesUnknown status
Albany Medical Center
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AlbanyUnited StatesUnknown status
University of New Mexico Cancer Center
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AlbuquerqueUnited StatesUnknown status
Texas Tech University Health Sciences Center-Amarillo
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AmarilloUnited StatesUnknown status
C S Mott Children's Hospital
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Ann ArborUnited StatesUnknown status
Mission Hospital
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AshevilleUnited StatesUnknown status
Children's Healthcare of Atlanta - Arthur M Blank Hospital
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AtlantaUnited StatesUnknown status
Augusta University Medical Center
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AugustaUnited StatesUnknown status
Children's Hospital Colorado
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AuroraUnited StatesUnknown status
Dell Children's Medical Center of Central Texas
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AustinUnited StatesUnknown status
Sinai Hospital of Baltimore
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BaltimoreUnited StatesUnknown status
University of Maryland/Greenebaum Cancer Center
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BaltimoreUnited StatesUnknown status
Johns Hopkins University/Sidney Kimmel Cancer Center
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BaltimoreUnited StatesUnknown status
Eastern Maine Medical Center
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BangorUnited StatesUnknown status
Walter Reed National Military Medical Center
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BethesdaUnited StatesUnknown status
Lehigh Valley Hospital - Muhlenberg
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BethlehemUnited StatesUnknown status
Children's Hospital of Alabama
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BirminghamUnited StatesUnknown status
University of Alabama at Birmingham Cancer Center
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BirminghamUnited StatesUnknown status
Saint Luke's Cancer Institute - Boise
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BoiseUnited StatesUnknown status
Massachusetts General Hospital Cancer Center
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BostonUnited StatesUnknown status
Brooklyn Hospital Center
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BrooklynUnited StatesUnknown status
Roswell Park Cancer Institute
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BuffaloUnited StatesUnknown status
University of Vermont and State Agricultural College
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BurlingtonUnited StatesUnknown status
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
West Virginia University Charleston Division
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CharlestonUnited StatesUnknown status
Novant Health Presbyterian Medical Center
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CharlotteUnited StatesUnknown status
Carolinas Medical Center/Levine Cancer Institute
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CharlotteUnited StatesUnknown status
University of Virginia Cancer Center
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CharlottesvilleUnited StatesUnknown status
T C Thompson Children's Hospital
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ChattanoogaUnited StatesUnknown status
University of Illinois
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ChicagoUnited StatesUnknown status
Lurie Children's Hospital-Chicago
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ChicagoUnited StatesUnknown status
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesUnknown status
Rainbow Babies and Childrens Hospital
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ClevelandUnited StatesUnknown status
Cleveland Clinic Foundation
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ClevelandUnited StatesUnknown status
Prisma Health Richland Hospital
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ColumbiaUnited StatesUnknown status
University of Missouri Children's Hospital
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ColumbiaUnited StatesUnknown status
Nationwide Children's Hospital
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ColumbusUnited StatesUnknown status
Driscoll Children's Hospital
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Corpus ChristiUnited StatesUnknown status
UT Southwestern/Simmons Cancer Center-Dallas
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DallasUnited StatesUnknown status
Medical City Dallas Hospital
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DallasUnited StatesUnknown status
Geisinger Medical Center
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DanvilleUnited StatesUnknown status
Dayton Children's Hospital
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DaytonUnited StatesUnknown status
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
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DenverUnited StatesUnknown status
Blank Children's Hospital
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Des MoinesUnited StatesUnknown status
Wayne State University/Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
Henry Ford Health Saint John Hospital
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DetroitUnited StatesUnknown status
Kaiser Permanente Downey Medical Center
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DowneyUnited StatesUnknown status
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Michigan State University Clinical Center
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East LansingUnited StatesUnknown status
Inova Fairfax Hospital
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Falls ChurchUnited StatesUnknown status
Sanford Broadway Medical Center
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FargoUnited StatesUnknown status
Hurley Medical Center
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FlintUnited StatesUnknown status
Broward Health Medical Center
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Fort LauderdaleUnited StatesUnknown status
Lee Memorial Health System
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Fort MyersUnited StatesUnknown status
Golisano Children's Hospital of Southwest Florida
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Fort MyersUnited StatesUnknown status
Cook Children's Medical Center
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Fort WorthUnited StatesUnknown status
University of Florida Health Science Center - Gainesville
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GainesvilleUnited StatesUnknown status
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Grand RapidsUnited StatesUnknown status
Saint Vincent Hospital Cancer Center Green Bay
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Green BayUnited StatesUnknown status
Greenville Cancer Treatment Center
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GreenvilleUnited StatesUnknown status
BI-LO Charities Children's Cancer Center
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GreenvilleUnited StatesUnknown status
East Carolina University
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GreenvilleUnited StatesUnknown status
Hackensack University Medical Center
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HackensackUnited StatesUnknown status
Connecticut Children's Medical Center
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HartfordUnited StatesUnknown status
Penn State Children's Hospital
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HersheyUnited StatesUnknown status
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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HollywoodUnited StatesUnknown status
Kapiolani Medical Center for Women and Children
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HonoluluUnited StatesUnknown status
University of Hawaii Cancer Center
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HonoluluUnited StatesUnknown status
Tripler Army Medical Center
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HonoluluUnited StatesUnknown status
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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HoustonUnited StatesUnknown status
Riley Hospital for Children
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IndianapolisUnited StatesUnknown status
Ascension Saint Vincent Indianapolis Hospital
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IndianapolisUnited StatesUnknown status
University of Iowa/Holden Comprehensive Cancer Center
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Iowa CityUnited StatesUnknown status
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
Nemours Children's Clinic-Jacksonville
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JacksonvilleUnited StatesUnknown status
Bronson Methodist Hospital
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KalamazooUnited StatesUnknown status
Kalamazoo Center for Medical Studies
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KalamazooUnited StatesUnknown status
Children's Mercy Hospitals and Clinics
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Kansas CityUnited StatesUnknown status
University of Kansas Cancer Center
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Kansas CityUnited StatesUnknown status
East Tennessee Childrens Hospital
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KnoxvilleUnited StatesUnknown status
Nevada Cancer Research Foundation NCORP
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Las VegasUnited StatesUnknown status
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las VegasUnited StatesUnknown status
Summerlin Hospital Medical Center
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Las VegasUnited StatesUnknown status
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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LebanonUnited StatesUnknown status
University of Kentucky/Markey Cancer Center
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LexingtonUnited StatesUnknown status
Arkansas Children's Hospital
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Little RockUnited StatesUnknown status
University of Arkansas for Medical Sciences
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Little RockUnited StatesUnknown status
Saint Barnabas Medical Center
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LivingstonUnited StatesUnknown status
Loma Linda University Medical Center
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Loma LindaUnited StatesUnknown status
Miller Children's and Women's Hospital Long Beach
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Long BeachUnited StatesUnknown status
Children's Hospital Los Angeles
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Los AngelesUnited StatesUnknown status
Cedars-Sinai Medical Center
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Los AngelesUnited StatesUnknown status
Norton Children's Hospital
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LouisvilleUnited StatesUnknown status
Covenant Children's Hospital
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LubbockUnited StatesUnknown status
Valley Children's Hospital
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MaderaUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesUnknown status
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesUnknown status
Loyola University Medical Center
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MaywoodUnited StatesUnknown status
Nicklaus Children's Hospital
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MiamiUnited StatesUnknown status
University of Miami Miller School of Medicine-Sylvester Cancer Center
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MiamiUnited StatesUnknown status
Miami Cancer Institute
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MiamiUnited StatesUnknown status
Children's Hospital of Wisconsin
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MilwaukeeUnited StatesUnknown status
NYU Langone Hospital - Long Island
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MineolaUnited StatesUnknown status
University of Minnesota/Masonic Cancer Center
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MinneapolisUnited StatesUnknown status
Children's Hospitals and Clinics of Minnesota - Minneapolis
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MinneapolisUnited StatesUnknown status
USA Health Strada Patient Care Center
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MobileUnited StatesUnknown status
Morristown Medical Center
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MorristownUnited StatesUnknown status
Vanderbilt University/Ingram Cancer Center
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NashvilleUnited StatesUnknown status
Newark Beth Israel Medical Center
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NewarkUnited StatesUnknown status
Saint Peter's University Hospital
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New BrunswickUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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New BrunswickUnited StatesUnknown status
Yale University
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New HavenUnited StatesUnknown status
The Steven and Alexandra Cohen Children's Medical Center of New York
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New Hyde ParkUnited StatesUnknown status
Tulane University School of Medicine
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New OrleansUnited StatesUnknown status
Ochsner Medical Center Jefferson
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New OrleansUnited StatesUnknown status
Children's Hospital New Orleans
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New OrleansUnited StatesUnknown status
Mount Sinai Hospital
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New YorkUnited StatesUnknown status
Laura and Isaac Perlmutter Cancer Center at NYU Langone
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New YorkUnited StatesUnknown status
NYP/Weill Cornell Medical Center
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New YorkUnited StatesUnknown status
Children's Hospital of The King's Daughters
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NorfolkUnited StatesUnknown status
UCSF Benioff Children's Hospital Oakland
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OaklandUnited StatesUnknown status
Kaiser Permanente-Oakland
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OaklandUnited StatesUnknown status
Advocate Children's Hospital-Oak Lawn
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Oak LawnUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
Children's Hospital and Medical Center of Omaha
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OmahaUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status
Children's Hospital of Orange County
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OrangeUnited StatesUnknown status
AdventHealth Orlando
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OrlandoUnited StatesUnknown status
Arnold Palmer Hospital for Children
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OrlandoUnited StatesUnknown status
Nemours Children's Hospital
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OrlandoUnited StatesUnknown status
Nemours Children's Clinic - Orlando
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OrlandoUnited StatesUnknown status
Orlando Health Cancer Institute
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OrlandoUnited StatesUnknown status
Lucile Packard Children's Hospital Stanford University
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Palo AltoUnited StatesUnknown status
Advocate Children's Hospital-Park Ridge
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Park RidgeUnited StatesUnknown status
Advocate Lutheran General Hospital
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Park RidgeUnited StatesUnknown status
Saint Joseph's Regional Medical Center
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PatersonUnited StatesUnknown status
Nemours Children's Clinic - Pensacola
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PensacolaUnited StatesUnknown status
Saint Jude Midwest Affiliate
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PeoriaUnited StatesUnknown status
Saint Christopher's Hospital for Children
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PhiladelphiaUnited StatesUnknown status
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesUnknown status
Phoenix Childrens Hospital
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PhoenixUnited StatesUnknown status
Children's Hospital of Pittsburgh of UPMC
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PittsburghUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Legacy Emanuel Children's Hospital
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PortlandUnited StatesUnknown status
Legacy Emanuel Hospital and Health Center
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PortlandUnited StatesUnknown status
Virginia Commonwealth University/Massey Cancer Center
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RichmondUnited StatesUnknown status
Carilion Children's
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RoanokeUnited StatesUnknown status
Mayo Clinic in Rochester
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RochesterUnited StatesUnknown status
University of Rochester
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RochesterUnited StatesUnknown status
Corewell Health Children's
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Royal OakUnited StatesUnknown status
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
Sutter Medical Center Sacramento
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SacramentoUnited StatesUnknown status
Primary Children's Hospital
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Salt Lake CityUnited StatesUnknown status
Children's Hospital of San Antonio
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San AntonioUnited StatesUnknown status
Methodist Children's Hospital of South Texas
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San AntonioUnited StatesUnknown status
University of Texas Health Science Center at San Antonio
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San AntonioUnited StatesUnknown status
Rady Children's Hospital - San Diego
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San DiegoUnited StatesUnknown status
UCSF Medical Center-Mission Bay
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San FranciscoUnited StatesUnknown status
UCSF Medical Center-Parnassus
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San FranciscoUnited StatesUnknown status
Memorial Health University Medical Center
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SavannahUnited StatesUnknown status
Maine Children's Cancer Program
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ScarboroughUnited StatesUnknown status
Seattle Children's Hospital
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SeattleUnited StatesUnknown status
Sanford USD Medical Center - Sioux Falls
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Sioux FallsUnited StatesUnknown status
Providence Sacred Heart Medical Center and Children's Hospital
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SpokaneUnited StatesUnknown status
Southern Illinois University School of Medicine
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SpringfieldUnited StatesUnknown status
Baystate Medical Center
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SpringfieldUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
Mercy Hospital Saint Louis
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St LouisUnited StatesUnknown status
Johns Hopkins All Children's Hospital
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St. PetersburgUnited StatesUnknown status
Overlook Hospital
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SummitUnited StatesUnknown status
State University of New York Upstate Medical University
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SyracuseUnited StatesUnknown status
Madigan Army Medical Center
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TacomaUnited StatesUnknown status
Mary Bridge Children's Hospital and Health Center
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TacomaUnited StatesUnknown status
Saint Joseph's Hospital/Children's Hospital-Tampa
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TampaUnited StatesUnknown status
Scott and White Memorial Hospital
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TempleUnited StatesUnknown status
Montefiore Medical Center - Moses Campus
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The BronxUnited StatesUnknown status
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
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ToledoUnited StatesUnknown status
Mercy Children's Hospital
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ToledoUnited StatesUnknown status
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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TorranceUnited StatesUnknown status
Banner University Medical Center - Tucson
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TucsonUnited StatesUnknown status
Natalie Warren Bryant Cancer Center at Saint Francis
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TulsaUnited StatesUnknown status
New York Medical College
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ValhallaUnited StatesUnknown status
MedStar Georgetown University Hospital
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Washington D.C.United StatesUnknown status
Children's National Medical Center
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Washington D.C.United StatesUnknown status
Saint Mary's Medical Center
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West Palm BeachUnited StatesUnknown status
Alfred I duPont Hospital for Children
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WilmingtonUnited StatesUnknown status
Wake Forest University Health Sciences
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Winston-SalemUnited StatesUnknown status
UMass Memorial Medical Center - University Campus
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WorcesterUnited StatesUnknown status

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