Recruiting
Phase 2

Blinatumomab & Dasatinib, Imatinib

Sponsor:

National Cancer Institute (NCI)

Code:

NCT06124157

Conditions

B Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 1 - 46

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Blinatumomab

Bone Marrow Biopsy

Calaspargase Pegol

Cyclophosphamide

Study Details

Brief summary:

This pilot trial assesses the effect of the combination of blinatumomab with dasatinib or imatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (Ph+) or ABL-class Philadelphia chromosome-like (Ph-like) B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib and imatinib are in a class of medications called tyrosine kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib or imatinib in combination with standard chemotherapy may work better in treating patients with Ph+ or Ph-like ABL-class B-ALL than dasatinib or imatinib with chemotherapy.

Conditions

B Acute Lymphoblastic Leukemia

Study ID

NCT06124157

Start date

May 30, 2025

Status verified date

Aug, 2026

Completion date

Dec 1, 2030

Anticipated

Primary completion date

Dec 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 46

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must be > 365 days and < 18 years (for AIEOP-BFM), > 365 days and < 22 years (for Children's Oncology Group \[COG\]) and > 365 days and < 46 years (for ALLTogether sites) at the time of enrollment
  • Newly-diagnosed Ph+ or ABL-class Ph-like B-ALL. Leukemic blasts must express CD19. ABL-class fusions are defined as rearrangements involving the following genes predicted to be sensitive to imatinib and/or dasatinib: ABL1, ABL2, CSF1R, and PDGFRB
  • Evidence of BCR::ABL1 should be documented by a clinically-validated assay prior to study entry on day 15 from the first dose of vinCRIStine during Induction therapy. ABL-class Ph-like B-ALL gene rearrangements should be documented by a clinically-validated assay and enrolled on study by day 1 of Blinatumomab Block 1. Accepted methods of detection include fluorescence in situ hybridization (FISH) using break-apart of colocalization signal probes, singleplex or multiplex reverse-transcription polymerase chain reaction (RT-PCR), whole-transcriptome or panel-based ribonucleic acid (RNA) sequencing (e.g., Hematologic Cancer Fusion Analysis, TruSight RNA Pan-Cancer Panel or equivalent). Confirmation of 5' fusion partner genes is not required for study enrollment
  • Patients with Ph+ B-ALL must have previously started Induction therapy, which includes vinCRIStine, a corticosteroid, pegaspargase or calaspargase pegol, with or without anthracycline, and/or other standard cytotoxic chemotherapy
  • Patients with Ph+ B-ALL have not received more than 14 days of systemic Induction therapy beginning with the first Induction dose of vinCRIStine
  • Patients with ABL-class Ph-like B-ALL must have previously completed 4 or 5 weeks of multiagent Induction chemotherapy (Induction 1A)
  • Patients may have started either imatinib or dasatinib prior to study entry but should have received no more than 14 days of TKI for Ph+ B-ALL or no more than 35 days of TKI for ABL-class Ph-like B-ALL
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of ≤ 2 or Karnofsky and Lansky performance scores ≥ 50%. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age
  • For pediatric patients (age 1-17 years): a glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m\^2, as determined by one of the following methods (must be performed within 7 days prior to enrollment unless otherwise indicated):

  • Estimated GFR (eGFR) ≥ 50 mL/min/1.73 m2
  • Measured GFR ≥ 50 mL/min/1.73 m\^2 (any age). If measured GFR is used, it must be performed using direct measurement with a nuclear blood sampling method or small molecule clearance method (iothalamate or other molecule per institutional standard
  • For adult patients (age 18 years or older): Creatinine clearance ≥ 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on body weight
  • Direct bilirubin < 2.0 mg/dL (34.2 micromoles/L) (must be performed within 7 days prior to enrollment unless otherwise indicated)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 10 x upper limit of normal (ULN) (must be performed within 7 days prior to enrollment unless otherwise indicated)
  • \* Shortening fraction of ≥ 27% by echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy \[repeat if necessary\]) OR

  • Left Ventricular Ejection fraction of ≥ 50% by radionuclide angiogram or echocardiogram (must be obtained within 21 days prior to enrollment and start of protocol therapy \[repeat if necessary\]) AND
  • Corrected QT Interval, QTc < 480mSec (must be obtained within 21 days prior to enrollment and start of protocol therapy \[repeat if necessary\])

  • Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis before study enrollment

Exclusion Criteria:

  • Known history of chronic myeloid leukemia (CML)
  • ABL-class Ph-like B-ALL who are CNS2 or CNS3 at end of Induction phase
  • ALL developing after a previous cancer treated with cytotoxic chemotherapy
  • Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
  • Down syndrome (trisomy 21)
  • Pregnancy and breast feeding

  • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A negative pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment
  • Lactating females who plan to breastfeed their infants
  • Sexually active male and female patients of reproductive potential who have not agreed to use an effective contraception method for the duration of treatment according to protocol

  • NOTE: Patients who could become pregnant or could father a child must use effective contraception during protocol treatment and for 30 days after the last dose of dasatinib or 14 days after the last dose of imatinib dose or per institutional standard of care for multiagent chemotherapy, whichever is longer
  • Prior treatment with TKIs before study entry with the exception of imatinib or dasatinib
  • Patients with congenital long QT syndrome, history of ventricular arrhythmias, or heart block
  • Patients with known Charcot-Marie-Tooth disease
  • Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with central nervous system (CNS) involvement

  • Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible. Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved
  • HIV-infected patients are eligible if on effective anti-retroviral therapy that does not interact with planned study agents and with undetectable viral load within 6 months of treatment
  • 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

Study Design

Enrollment

222 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stratum I (Ph+ ALL)

See detailed description

experimental: Stratum II (PDGFRB ABL-Class fusions)

See detailed description.

experimental: Stratum III (non-PDGFRB ABL-Class fusions)

See detailed description.

Interventions

Biospecimen Collection

Undergo blood and CSF sample collection

Blinatumomab

Receive IV

Bone Marrow Biopsy

Undergo bone marrow biopsy

Calaspargase Pegol

Receive IV

Cyclophosphamide

Receive IV

Cytarabine

Receive IV or subcutaneously

Dasatinib

Receive PO

Daunorubicin

Receive IV

Doxorubicin

Receive IV

Echocardiography Test

Undergo ECHO

Imatinib

Given PO

Leucovorin

Receive PO or IV

Mercaptopurine

Receive PO

Methotrexate

Receive IT or IV or PO

Multigated Acquisition Scan

Undergo MUGA

Pegaspargase

Receive IV or intramuscularly

Prednisolone

Receive PO

Prednisone

Receive PO

Radiation Therapy

Undergo radiation therapy

Thioguanine

Receive PO

Vincristine

Receive IV

Primary outcome measure

  • Philadelphia chromosome-positive (Ph+) (BCR::ABL1-rearranged) 3-year event free survival (EFS) [ Time Frame: Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years ]
  • ABL-class Ph-like B-ALL 3-year event free survival (EFS) [ Time Frame: Time from enrollment to first event, relapse, second malignancy, or death in complete remission, or last contact for those who are event-free, assessed up to 3 years ]
  • Incidence of adverse events [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Locations

Children's Hospital of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Principal Investigator:

Matthew A. Kutny

Phoenix Childrens Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Site Public Contact

602-546-0920

Principal Investigator:

Dana B. Salzberg

Banner University Medical Center - Tucson

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Monica M. Davini

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202-3591

Contacts

Site Public Contact

501-364-7373

Principal Investigator:

Michael W. Bishop

Kaiser Permanente Downey Medical Center

Recruiting

Downey, California, United States, 90242

Contacts

Site Public Contact

626-564-3455

Principal Investigator:

Robert M. Cooper

Loma Linda University Medical Center

Recruiting

Loma Linda, California, United States, 92354

Contacts

Site Public Contact

909-558-4050

Principal Investigator:

Albert Kheradpour

Miller Children's and Women's Hospital Long Beach

Recruiting

Long Beach, California, United States, 90806

Contacts

Site Public Contact

562-933-5600

Principal Investigator:

Jacqueline N. Casillas

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Site Public Contact

323-361-4110

Principal Investigator:

Andrew Doan

Valley Children's Hospital

Recruiting

Madera, California, United States, 93636

Contacts

Principal Investigator:

Ruetima Titapiwatanakun

UCSF Benioff Children's Hospital Oakland

Recruiting

Oakland, California, United States, 94609

Contacts

Principal Investigator:

Karen R. Rabin

Kaiser Permanente-Oakland

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691Kpoct@kp.org

Principal Investigator:

Aarati V. Rao

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Contacts

Principal Investigator:

Elyssa M. Rubin

Lucile Packard Children's Hospital Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Principal Investigator:

Jay Michael S. Balagtas

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Site Public Contact

916-734-3089

Principal Investigator:

Marcio H. Malogolowkin

Rady Children's Hospital - San Diego

Recruiting

San Diego, California, United States, 92123

Contacts

Site Public Contact

858-966-5934

Principal Investigator:

William D. Roberts

UCSF Medical Center-Mission Bay

Recruiting

San Francisco, California, United States, 94158

Contacts

Principal Investigator:

Karen R. Rabin

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Kelly W. Maloney

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Site Public Contact

860-545-9981

Principal Investigator:

Michael S. Isakoff

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Principal Investigator:

Farzana Pashankar

Alfred I duPont Hospital for Children

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Principal Investigator:

Emi H. Caywood

MedStar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Site Public Contact

202-444-2223

Principal Investigator:

Caileigh Pudela

Children's National Medical Center

Recruiting

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

Contacts

Principal Investigator:

Jeffrey S. Dome

Golisano Children's Hospital of Southwest Florida

Recruiting

Fort Myers, Florida, United States, 33908

Contacts

Principal Investigator:

Emad K. Salman

UF Health Cancer Institute - Gainesville

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Site Public Contact

352-273-8010

Principal Investigator:

Brian Stover

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Site Public Contact

954-265-1847OHR@mhs.net

Principal Investigator:

Iftikhar Hanif

Nemours Children's Clinic-Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Principal Investigator:

Emi H. Caywood

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Julio C. Barredo

Arnold Palmer Hospital for Children

Recruiting

Orlando, Florida, United States, 32806

Contacts

Principal Investigator:

Zhongbo Hu

Nemours Children's Hospital

Recruiting

Orlando, Florida, United States, 32827

Contacts

Principal Investigator:

Emi H. Caywood

Nemours Children's Clinic - Pensacola

Recruiting

Pensacola, Florida, United States, 32504

Contacts

Principal Investigator:

Jeffrey H. Schwartz

Johns Hopkins All Children's Hospital

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Principal Investigator:

Jennifer B. Dean

Saint Joseph's Hospital/Children's Hospital-Tampa

Recruiting

Tampa, Florida, United States, 33607

Contacts

Principal Investigator:

Don E. Eslin

Saint Mary's Medical Center

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

Site Public Contact

561-822-4745

Principal Investigator:

Matthew D. Ramirez

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Principal Investigator:

Lauren Raney

Augusta University Medical Center

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Principal Investigator:

Colleen H. McDonough

Atrium Health Navicent

Recruiting

Macon, Georgia, United States, 31201

Contacts

Principal Investigator:

Sushmita Nair

Memorial Health University Medical Center

Recruiting

Savannah, Georgia, United States, 31404

Contacts

Principal Investigator:

Andrew L. Pendleton

Kapiolani Medical Center for Women and Children

Recruiting

Honolulu, Hawaii, United States, 96826

Contacts

Site Public Contact

808-983-6090

Principal Investigator:

Wade T. Kyono

Saint Luke's Cancer Institute - Boise

Recruiting

Boise, Idaho, United States, 83712

Contacts

Principal Investigator:

Martha M. Pacheco

Lurie Children's Hospital-Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

773-880-4562

Principal Investigator:

Loretta S. Li

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Dipti S. Dighe

University of Chicago Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Gabrielle Lapping-Carr

Advocate Children's Hospital-Oak Lawn

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Site Public Contact

847-723-7570

Principal Investigator:

Rebecca E. McFall

Advocate Children's Hospital-Park Ridge

Recruiting

Park Ridge, Illinois, United States, 60068

Contacts

Principal Investigator:

Rebecca E. McFall

OSF Children's Hospital of Illinois

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Principal Investigator:

Prerna Kumar

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

217-545-7929

Principal Investigator:

Gregory P. Brandt

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Site Public Contact

800-248-1199

Principal Investigator:

Sandeep Batra

Blank Children's Hospital

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Principal Investigator:

Samantha L. Mallory

University of Iowa/Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Site Public Contact

800-237-1225

Principal Investigator:

Andrew P. Groves

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

James T. Badgett

Norton Children's Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Principal Investigator:

Michael J. Ferguson

Children's Hospital New Orleans

Recruiting

New Orleans, Louisiana, United States, 70118

Contacts

Site Public Contact

504-894-5377

Principal Investigator:

Maria C. Velez-Yanguas

Ochsner Medical Center Jefferson

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Principal Investigator:

Craig Lotterman

Maine Children's Cancer Program

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Principal Investigator:

Eric C. Larsen

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Site Public Contact

410-601-9083

Principal Investigator:

Jason M. Fixler

Johns Hopkins University/Sidney Kimmel Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Principal Investigator:

Stacy L. Cooper

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889-5600

Contacts

Site Public Contact

301-319-2100

Principal Investigator:

Kip R. Hartman

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Site Public Contact

877-442-3324

Principal Investigator:

Melissa A. Burns

UMass Memorial Medical Center - University Campus

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Principal Investigator:

Stefanie R. Lowas

C S Mott Children's Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Site Public Contact

800-865-1125

Principal Investigator:

Joshua W. Goldman

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Principal Investigator:

Kathleen Y. Butler

Bronson Methodist Hospital

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Principal Investigator:

Kathleen Y. Butler

Children's Hospitals and Clinics of Minnesota - Minneapolis

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Principal Investigator:

Michael K. Richards

University of Minnesota/Masonic Cancer Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Site Public Contact

612-624-2620

Principal Investigator:

Peter M. Gordon

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Madeleine O'Keefe

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Site Public Contact

601-815-6700

Principal Investigator:

Amanda Strobel

Children's Mercy Hospitals and Clinics

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Principal Investigator:

Keith J. August

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Laura G. Schuettpelz

Children's Hospital and Medical Center of Omaha

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Site Public Contact

402-955-3949

Principal Investigator:

Jill C. Beck

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Recruiting

Las Vegas, Nevada, United States, 89135

Contacts

Principal Investigator:

Alan K. Ikeda

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

Angela Ricci

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Site Public Contact

551-996-2897

Principal Investigator:

Jing Chen

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Site Public Contact

973-971-5900

Principal Investigator:

Kathryn L. Laurie

Jersey Shore Medical Center

Recruiting

Neptune City, New Jersey, United States, 07753

Contacts

Site Public Contact

732-776-4240

Principal Investigator:

Jing Chen

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Site Public Contact

732-235-8675

Principal Investigator:

Marissa Botwinick

Saint Joseph's Regional Medical Center

Recruiting

Paterson, New Jersey, United States, 07503

Contacts

Site Public Contact

973-754-2207HallL@sjhmc.org

Principal Investigator:

Alissa Kahn

Presbyterian Hospital

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Site Public Contact

505-559-6113wburman@phs.org

Principal Investigator:

Beeling Armijo

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Principal Investigator:

Jessica M. Valdez

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Site Public Contact

518-262-5513

Principal Investigator:

Lauren R. Weintraub

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Principal Investigator:

Lisa Niswander

NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Contacts

Principal Investigator:

Chana L. Glasser

The Steven and Alexandra Cohen Children's Medical Center of New York

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Site Public Contact

718-470-3460

Principal Investigator:

Hiren Patel

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator:

Lewis B. Silverman

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Kavitha Ramaswamy

NYP/Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-746-1848

Principal Investigator:

Jaclyn Rosenzweig

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Site Public Contact

800-862-2215

Principal Investigator:

Laura E. Hogan

State University of New York Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Site Public Contact

315-464-5476

Principal Investigator:

Melanie A. Comito

Montefiore Medical Center - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

Principal Investigator:

Alice Lee

New York Medical College

Recruiting

Valhalla, New York, United States, 10595

Contacts

Site Public Contact

914-594-3794

Principal Investigator:

Andrew J. Bellantoni

Mission Hospital

Recruiting

Asheville, North Carolina, United States, 28801

Contacts

Principal Investigator:

Douglas J. Scothorn

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Thomas B. Alexander

Carolinas Medical Center/Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Site Public Contact

800-804-9376

Principal Investigator:

Joel A. Kaplan

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Site Public Contact

888-275-3853

Principal Investigator:

Jessica M. Sun

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Site Public Contact

336-713-6771

Principal Investigator:

Sarah Supples

Sanford Broadway Medical Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Samuel J. Milanovich

Children's Hospital Medical Center of Akron

Recruiting

Akron, Ohio, United States, 44308

Contacts

Site Public Contact

330-543-3193

Principal Investigator:

Erin Wright

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Principal Investigator:

Erin H. Breese

Rainbow Babies and Childrens Hospital

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Site Public Contact

216-844-5437

Principal Investigator:

Duncan S. Stearns

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Principal Investigator:

Mark A. Ranalli

Dayton Children's Hospital

Recruiting

Dayton, Ohio, United States, 45404

Contacts

Site Public Contact

800-228-4055

Principal Investigator:

Jordan M. Wright

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Recruiting

Toledo, Ohio, United States, 43606

Contacts

Principal Investigator:

Jamie L. Dargart

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Rene Y. McNall-Knapp

Lehigh Valley Hospital-Cedar Crest

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Principal Investigator:

Jacob A. Troutman

Penn State Children's Hospital

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Site Public Contact

717-531-6012

Principal Investigator:

Lisa M. McGregor

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Sarah K. Tasian

Saint Christopher's Hospital for Children

Recruiting

Philadelphia, Pennsylvania, United States, 19134

Contacts

Site Public Contact

215-427-8991

Principal Investigator:

Gregory E. Halligan

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Principal Investigator:

Colleen Mathews

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Site Public Contact

401-444-1488

Principal Investigator:

Bradley DeNardo

Prisma Health Richland Hospital

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Principal Investigator:

Stuart L. Cramer

BI-LO Charities Children's Cancer Center

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Principal Investigator:

Aniket Saha

Sanford USD Medical Center - Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57117-5134

Contacts

Principal Investigator:

Jordan Fritch-Hanson

East Tennessee Childrens Hospital

Recruiting

Knoxville, Tennessee, United States, 37916

Contacts

Site Public Contact

865-541-8266

Principal Investigator:

Susan E. Spiller

The Children's Hospital at TriStar Centennial

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Site Public Contact

615-342-1919

Principal Investigator:

Clinton M. Carroll

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Site Public Contact

800-811-8480

Principal Investigator:

Brianna N. Smith

Dell Children's Medical Center of Central Texas

Recruiting

Austin, Texas, United States, 78723

Contacts

Principal Investigator:

Shannon M. Cohn

Driscoll Children's Hospital

Recruiting

Corpus Christi, Texas, United States, 78411

Contacts

Principal Investigator:

Nkechi I. Mba

Medical City Dallas Hospital

Recruiting

Dallas, Texas, United States, 75230

Contacts

Site Public Contact

972-566-5588

Principal Investigator:

Maurizio L. Ghisoli

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Tamra L. Slone

El Paso Children's Hospital

Recruiting

El Paso, Texas, United States, 79905

Contacts

Principal Investigator:

Benjamin Carcamo

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Principal Investigator:

Kenneth M. Heym

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-798-1354burton@bcm.edu

Principal Investigator:

Chelsea Vrana

Covenant Children's Hospital

Recruiting

Lubbock, Texas, United States, 79410

Contacts

Principal Investigator:

Kishor M. Bhende

UMC Cancer Center / UMC Health System

Recruiting

Lubbock, Texas, United States, 79415

Contacts

Site Public Contact

806-775-8590

Principal Investigator:

Erin K. Barr

Children's Hospital of San Antonio

Recruiting

San Antonio, Texas, United States, 78207

Contacts

Principal Investigator:

Julie Voeller

Methodist Children's Hospital of South Texas

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Jose M. Esquilin

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Anne-Marie R. Langevin

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Site Public Contact

801-585-5270

Principal Investigator:

Luke D. Maese

University of Vermont and State Agricultural College

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Site Public Contact

802-656-8990rpo@uvm.edu

Principal Investigator:

Jessica L. Heath

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Principal Investigator:

Brian C. Belyea

Inova Fairfax Hospital

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Principal Investigator:

Robin Y. Dulman

Children's Hospital of The King's Daughters

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Principal Investigator:

Melissa S. Mark

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

Jordyn R. Griffin

Carilion Children's

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Principal Investigator:

Erwood G. Edwards

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Site Public Contact

866-987-2000

Principal Investigator:

Sarah E. Leary

Providence Sacred Heart Medical Center and Children's Hospital

Recruiting

Spokane, Washington, United States, 99204

Contacts

Principal Investigator:

Judy L. Felgenhauer

Mary Bridge Children's Hospital and Health Center

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Principal Investigator:

Robert G. Irwin

Saint Vincent Hospital Cancer Center Green Bay

Recruiting

Green Bay, Wisconsin, United States, 54301

Contacts

Principal Investigator:

Catherine A. Long

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Principal Investigator:

Cathy A. Lee-Miller

Children's Hospital of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-955-4727MACCCTO@mcw.edu

Principal Investigator:

Paul D. Harker-Murray

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Principal Investigator:

Sarah J. McKillop

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Principal Investigator:

Stephanie M. Villeneuve

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 4, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-04.