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NCT03581292Active, not recruitingPhase 2

Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations

A Phase 2 Study of Veliparib (ABT-888) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients With Newly Diagnosed High-Grade Glioma (HGG) Without H3 K27M or BRAFV600 Mutations

Source: ClinicalTrials.gov · Last updated 6 Oct 2026

Brief summary (registry, in English)

This phase II trial studies how well veliparib, radiation therapy, and temozolomide work in treating patients with newly diagnosed malignant glioma without H3 K27M or BRAFV600 mutations. Poly adenosine diphosphate (ADP) ribose polymerases (PARPs) are proteins that help repair DNA mutations. PARP inhibitors, such as veliparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib, radiation therapy, and temozolomide may work better in treating patients with newly diagnosed malignant glioma without H3 K27M or BRAFV600 mutations compared to radiation therapy and temozolomide alone.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
38 (actual)
First submitted
4 Jul 2018
Start date
6 Nov 2018
Primary completion date
31 Mar 2023
Lead sponsor
Children's Oncology Group
NCT number
NCT03581292

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 38
  • From 6 Nov 2018 to the primary completion date, 31 Mar 2023
  • 163 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.

Prior treatment

  • Prior allogenic bone marrow transplant or double umbilical cord blood transplantation
  • Patients must not have received any prior tumor-directed therapy including radiation therapy, chemotherapy (tumor-directed therapy), molecularly targeted agents, or immunotherapy for the treatment of HGG other than surgical intervention and/or corticosteroids
  • Lumbar CSF cytology is not required, but may be performed if clinically indicated prior to study enrollment. If lumbar CSF cytology is positive, the patient is considered to have M+ disease and is ineligible
    • Note: False positive cytology can occur within 10 days of surgery
  • Patients who are not able to receive protocol specified radiation therapy
  • Patients must not be currently receiving other anti-cancer agents
  • Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 6 months after the last dose of protocol-specified chemotherapy

Other illness

  • Patients with M+ disease (defined as neuraxis dissemination either by imaging or by cytology)
  • Patients with treatment-related acute myeloid leukemia (AML) (t-AML)/myelodysplastic syndrome (MDS) or with features suggestive of AML/MDS
  • Patients with known constitutional mismatch repair deficiency syndrome (CMMR-D)/biallelic mismatch repair deficiency (bMMRD)

Other

  • Patients with the following histologies:
    • Diffuse astrocytoma (grade 2)
    • Oligodendrogliomas (any grade)
    • Pleomorphic xanthoastrocytoma (PXA, any grade)
  • Patients with primary tumor location of brainstem or spinal cord
  • Patients with gliomatosis cerebri type 1 or 2
  • Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained

Who the study is looking for

  • Stratum 1 (IDH wild-type): Patients must be \>= 3 years of age and =\< 21 years of age at the time of enrollment
    • Please note Stratum 1 was closed to accrual on January 24, 2020
  • Stratum 2 (IDH mutant): Patients must be \>= 3 years of age and =\< 25 years of age at the time of enrollment
  • Patients must have eligibility confirmed by rapid central pathology and central molecular screening reviews performed on APEC14B1:
    • Newly-diagnosed high-grade glioma such as anaplastic astrocytoma or glioblastoma
    • Negative results for H3 K27M by immunohistochemistry (IHC)
    • Negative results for BRAFV600 mutation by next-generation sequencing (NGS)
  • Patients must have histological verification of diagnosis. Patients with M+ disease (defined as evidence of neuraxis dissemination) are not eligible. Cerebrospinal fluid (CSF) cytology is not required but may be obtained if clinically indicated prior to study enrollment. If cytology is positive, the patient would be considered to have metastatic disease and would, therefore, be ineligible
  • Pre-operative and post-operative brain magnetic resonance imaging (MRI) with and without contrast must be obtained. The requirement for a post-operative MRI is waived for patients who undergo biopsy only. A spine MRI is not required, but may be obtained if clinically indicated. If the spine MRI is positive, the patient would be considered to have M+ disease (defined as neuraxis dissemination) and would be ineligible
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
  • Peripheral absolute neutrophil count (ANC) \>= 1,000/uL (within 7 days prior to enrollment)
  • Platelet count \>= 100,000/uL (transfusion independent) (within 7 days prior to enrollment)
  • Hemoglobin \>= 8.0 gm/dL (can be transfused) (within 7 days prior to enrollment)
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/sex as follows (within 7 days prior to enrollment):
    • 3 to \< 6 years: 0.8 (male and female) maximum serum creatinine (mg/dL)
    • 6 to \< 10 years: 1 (male and female) maximum serum creatinine (mg/dL)
    • 10 to \< 13 years: 1.2 (male and female) maximum serum creatinine (mg/dL)
    • 13 to \< 16 years: 1.5 (male), 1.4 (female) maximum serum creatinine (mg/dL)
    • \>= 16 years: 1.7 (male), 1.4 (female) maximum serum creatinine (mg/dL)
  • Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L
  • Patients with seizure disorder may be enrolled if seizures are well-controlled (i.e., patients must not have required rescue medications for uncontrolled seizures within 14 days prior to enrollment)
  • Patients must be enrolled and protocol therapy must be projected to begin no later than 31 days after definitive surgery (Day 0). If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Age in the registry: 3 years to 25 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (163)

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
John Hunter Children's Hospital
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Hunter Regional Mail CentreAustraliaUnknown status
Royal Children's Hospital
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ParkvilleAustraliaUnknown status
Perth Children's Hospital
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PerthAustraliaUnknown status
Sydney Children's Hospital
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RandwickAustraliaUnknown status
Queensland Children's Hospital
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South BrisbaneAustraliaUnknown status
The Children's Hospital at Westmead
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WestmeadAustraliaUnknown status
Alberta Children's Hospital
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CalgaryCanadaUnknown status
IWK Health Centre
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HalifaxCanadaUnknown status
McMaster Children's Hospital at Hamilton Health Sciences
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HamiltonCanadaUnknown status
The Montreal Children's Hospital of the MUHC
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MontrealCanadaUnknown status
Centre Hospitalier Universitaire Sainte-Justine
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MontrealCanadaUnknown status
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
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QuébecCanadaUnknown status
Janeway Child Health Centre
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St. John'sCanadaUnknown status
British Columbia Children's Hospital
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VancouverCanadaUnknown status
Christchurch Hospital
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ChristchurchNew ZealandUnknown status
Starship Children's Hospital
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GraftonNew ZealandUnknown status
HIMA San Pablo Oncologic Hospital
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CaguasPuerto RicoUnknown 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
Lehigh Valley Hospital-Cedar Crest
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AllentownUnited 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
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
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
Children's Hospital of Alabama
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BirminghamUnited StatesUnknown status
Saint Luke's Cancer Institute - Boise
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BoiseUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Massachusetts General Hospital Cancer Center
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BostonUnited StatesUnknown status
Roswell Park Cancer Institute
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BuffaloUnited 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
Carolinas Medical Center/Levine Cancer Institute
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CharlotteUnited 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
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesUnknown status
Lurie Children's Hospital-Chicago
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ChicagoUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesUnknown status
Cleveland Clinic Foundation
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ClevelandUnited StatesUnknown status
Rainbow Babies and Childrens Hospital
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ClevelandUnited StatesUnknown status
Prisma Health Richland 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
Medical City Dallas Hospital
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DallasUnited StatesUnknown status
UT Southwestern/Simmons Cancer Center-Dallas
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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
Blank Children's Hospital
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Des MoinesUnited StatesUnknown status
Henry Ford Health Saint John Hospital
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DetroitUnited StatesUnknown status
Wayne State University/Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
Kaiser Permanente Downey Medical Center
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DowneyUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Sanford Broadway Medical Center
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FargoUnited 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
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Grand RapidsUnited 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
Connecticut Children's Medical Center
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HartfordUnited 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
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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HoustonUnited StatesUnknown status
UT MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Ascension Saint Vincent Indianapolis Hospital
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IndianapolisUnited StatesUnknown status
Riley Hospital for Children
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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
Children's Mercy Hospitals and Clinics
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Kansas CityUnited StatesUnknown status
East Tennessee Childrens Hospital
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KnoxvilleUnited StatesUnknown status
Summerlin Hospital Medical Center
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Las VegasUnited StatesUnknown status
University Medical Center of Southern Nevada
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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
Sunrise Hospital and 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
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
Mattel Children's Hospital UCLA
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Los AngelesUnited StatesUnknown status
Norton Children's Hospital
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LouisvilleUnited 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
Saint Jude Children's Research Hospital
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MemphisUnited StatesUnknown status
Banner Children's at Desert
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MesaUnited StatesUnknown status
University of Miami Miller School of Medicine-Sylvester Cancer Center
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MiamiUnited StatesUnknown status
Nicklaus Children's Hospital
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MiamiUnited StatesUnknown status
Children's Hospital of Wisconsin
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MilwaukeeUnited StatesUnknown status
Children's Hospitals and Clinics of Minnesota - Minneapolis
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MinneapolisUnited StatesUnknown status
University of Minnesota/Masonic Cancer Center
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MinneapolisUnited StatesUnknown status
USA Health Strada Patient Care Center
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MobileUnited StatesUnknown status
West Virginia University Healthcare
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MorgantownUnited StatesUnknown status
Morristown Medical Center
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MorristownUnited StatesUnknown status
The Children's Hospital at TriStar Centennial
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NashvilleUnited StatesUnknown status
Vanderbilt University/Ingram Cancer Center
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NashvilleUnited StatesUnknown status
Saint Peter's University Hospital
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New BrunswickUnited StatesUnknown status
Yale University
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New HavenUnited 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
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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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
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
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
Arnold Palmer Hospital for Children
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OrlandoUnited StatesUnknown status
Nemours Children's Hospital
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OrlandoUnited StatesUnknown status
AdventHealth Orlando
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OrlandoUnited StatesUnknown status
Lucile Packard Children's Hospital Stanford University
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Palo AltoUnited StatesUnknown status
OSF Children's Hospital of Illinois
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PeoriaUnited 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
Naval Medical Center - Portsmouth
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PortsmouthUnited StatesUnknown status
Rhode Island Hospital
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ProvidenceUnited StatesUnknown status
Renown Regional Medical Center
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RenoUnited StatesUnknown status
VCU Massey Comprehensive Cancer Center
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RichmondUnited 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
Primary Children's Hospital
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Salt Lake CityUnited StatesUnknown status
University of Texas Health Science Center at 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
Children's Hospital of San Antonio
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San AntonioUnited StatesUnknown status
Memorial Health University Medical Center
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SavannahUnited 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
Cardinal Glennon Children's Medical Center
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St LouisUnited StatesUnknown status
Mercy Hospital Saint Louis
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St LouisUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
Johns Hopkins All Children's Hospital
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St. PetersburgUnited 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
Tampa General Hospital
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TampaUnited 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
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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TorranceUnited StatesUnknown status
New York Medical College
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ValhallaUnited StatesUnknown status
Children's National Medical Center
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Washington D.C.United StatesUnknown status
MedStar Georgetown University Hospital
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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

This page is information, not medical advice. Discuss any trial with your doctor.