Recruiting
Phase 3

Triptorelin

Sponsor:

Children's Oncology Group

Code:

NCT06513962

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: Female

Age: 0 - 39

Healthy Volunteers: Not accepted

Interventions

Best Practice

Biospecimen Collection

Electronic Health Record Review

Survey Administration

Triptorelin Pamoate

Study Details

Brief summary:

This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future. Triptorelin works by blocking certain hormones and causing the ovaries to slow down or pause normal activity. The triptorelin used in this study stays active in the body for 24 weeks or about 6 months after a dose is given. After triptorelin is cleared from the body, the ovaries resume normal activities. Adding triptorelin before the start of chemotherapy treatment may reduce the chances of damage to the ovaries.

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Study ID

NCT06513962

Start date

Feb 27, 2025

Status verified date

Aug, 2026

Completion date

Oct 30, 2029

Anticipated

Primary completion date

Oct 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0 - 39

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • < 40 years of age at the time of enrollment
  • Patient must be a post-menarchal female and report that their initial menstrual period occurred > 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.)
  • Newly diagnosed with first cancer, exclusive of breast cancer.

  • Note: Apart from breast carcinoma, other tumor types originating in the breast are permitted (e.g., sarcoma, lymphoma).
  • Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard, or dacarbazine (DTIC).
  • Expected cumulative cyclophosphamide equivalent dose (CED):

  • For patients < 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m\^2 cumulative CED calculated according to the equation and specified drugs listed. Dacarbazine is not an eligible drug in this age group.
  • For patients ≥ 20 years of age and < 35 years old at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed below that contribute to CED. Dacarbazine is not an eligible drug in this age group.
  • For patients ≥ 35 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators listed that contribute to CED and/or dacarbazine, which IS an eligible drug in this age group.

Note that CED includes all administration routes: intravenous (IV), oral (PO), IM.

  • The planned total duration of therapy with eligible alkylators is expected to be completed within one year after enrollment. Note: treatment plans with prolonged maintenance periods extending beyond one year are permitted so long as those maintenance treatments are not expected to contain eligible alkylators.
  • 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.

Exclusion Criteria:

  • Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI).
  • Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged).
  • Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc.
  • Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions.
  • Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period.
  • Receipt of systemic chemotherapy (except for steroids and intrathecal chemotherapy) more than 7 days prior to study enrollment.
  • Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI).
  • Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential.
  • Lactating females who plan to breastfeed their infants for the duration of triptorelin therapy (24 weeks per dose).
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of triptorelin therapy (24 weeks per dose).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm A (triptorelin)

Patients receive triptorelin IM up to 14 days prior to or within 7 days after the start of standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study.

active comparator: Arm B (usual care)

Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.

Interventions

Best Practice

Receive standard chemotherapy

Biospecimen Collection

Undergo blood sample collection

Electronic Health Record Review

Ancillary studies

Survey Administration

Ancillary studies

Triptorelin Pamoate

Given IM

Primary outcome measure

  • Number of enrollments of newly diagnosed AYA female cancer patients age < 40 years [ Time Frame: Up to 2 years post-chemotherapy ]
  • Accrual rates of newly diagnosed AYA female cancer patients age < 40 years [ Time Frame: Up to 2 years post-chemotherapy ]
  • Anti-mullerian hormone (AMH) levels [ Time Frame: At 2 years post-chemotherapy ]

Central Contacts and Locations

Locations

Children's Hospital of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Principal Investigator:

Jamie M. Aye

University of Alabama at Birmingham Cancer Center

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Site Public Contact

gingerreeves@uabmc.edu

Principal Investigator:

Vanessa Eulo

USA Health Strada Patient Care Center

Recruiting

Mobile, Alabama, United States, 36604

Contacts

Site Public Contact

800-388-8721

Principal Investigator:

Hamayun Imran

Phoenix Childrens Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Site Public Contact

602-546-0920

Principal Investigator:

Alexandra M. Walsh

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

Mercy Hospital Fort Smith

Recruiting

Fort Smith, Arkansas, United States, 72903

Contacts

Site Public Contact

800-378-9373

Principal Investigator:

Jay W. Carlson

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202-3591

Contacts

Site Public Contact

501-364-7373

Principal Investigator:

Michael W. Bishop

CARTI Cancer Center

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Principal Investigator:

Jay W. Carlson

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Principal Investigator:

Rusha Bhandari

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Principal Investigator:

H. I. Su

Loma Linda University Medical Center

Recruiting

Loma Linda, California, United States, 92354

Contacts

Site Public Contact

909-558-4050

Principal Investigator:

Albert Kheradpour

Mattel Children's Hospital UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Site Public Contact

310-825-6708

Principal Investigator:

Noah C. Federman

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

Sutter Medical Center Sacramento

Recruiting

Sacramento, California, United States, 95816

Contacts

Principal Investigator:

Sandra Baril

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

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Jenna M. Demedis

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Recruiting

Denver, Colorado, United States, 80218

Contacts

Principal Investigator:

Florence Choo

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Site Public Contact

860-545-9981

Principal Investigator:

Michael S. Isakoff

Beebe Medical Center

Recruiting

Lewes, Delaware, United States, 19958

Contacts

Principal Investigator:

Gregory A. Masters

Beebe South Coastal Health Campus

Recruiting

Millville, Delaware, United States, 19967

Contacts

Principal Investigator:

Gregory A. Masters

Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Contacts

Principal Investigator:

Gregory A. Masters

Medical Oncology Hematology Consultants PA

Recruiting

Newark, Delaware, United States, 19713

Contacts

Principal Investigator:

Gregory A. Masters

Christiana Care Health System-Christiana Hospital

Recruiting

Newark, Delaware, United States, 19718

Contacts

Principal Investigator:

Gregory A. Masters

Beebe Health Campus

Recruiting

Rehoboth Beach, Delaware, United States, 19971

Contacts

Principal Investigator:

Gregory A. Masters

Christiana Care Health System-Wilmington Hospital

Recruiting

Wilmington, Delaware, United States, 19801

Contacts

Principal Investigator:

Gregory A. Masters

Alfred I duPont Hospital for Children

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Principal Investigator:

Vibhuti Agarwal

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

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:

Vibhuti Agarwal

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:

Meghan McCormick

Nicklaus Children's Hospital

Recruiting

Miami, Florida, United States, 33155

Contacts

Site Public Contact

888-624-2778

Principal Investigator:

Maggie E. Fader

Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Contacts

Site Public Contact

786-596-2000

Principal Investigator:

Doured Daghistani

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Principal Investigator:

Fouad M. Hajjar

Nemours Children's Hospital

Recruiting

Orlando, Florida, United States, 32827

Contacts

Principal Investigator:

Vibhuti Agarwal

Nemours Children's Clinic - Pensacola

Recruiting

Pensacola, Florida, United States, 32504

Contacts

Principal Investigator:

Jeffrey H. Schwartz

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Principal Investigator:

Andrew J. Galligan

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:

Lillian R. Meacham

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

OSF Saint Anthony's Health Center

Recruiting

Alton, Illinois, United States, 62002

Contacts

Site Public Contact

618-463-5623

Principal Investigator:

Jay W. Carlson

Lurie Children's Hospital-Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

773-880-4562

Principal Investigator:

Jennifer L. Reichek

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Shira N. Dinner

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Dipti S. Dighe

Northwestern Medicine Cancer Center Kishwaukee

Recruiting

DeKalb, Illinois, United States, 60115

Contacts

Principal Investigator:

Shira N. Dinner

Northwestern Medicine Cancer Center Delnor

Recruiting

Geneva, Illinois, United States, 60134

Contacts

Principal Investigator:

Shira N. Dinner

Northwestern Medicine Glenview Outpatient Center

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Site Public Contact

312-695-1102

Principal Investigator:

Shira N. Dinner

Northwestern Medicine Grayslake Outpatient Center

Recruiting

Grayslake, Illinois, United States, 60030

Contacts

Site Public Contact

312-695-1102

Principal Investigator:

Shira N. Dinner

Northwestern Medicine Lake Forest Hospital

Recruiting

Lake Forest, Illinois, United States, 60045

Contacts

Principal Investigator:

Shira N. Dinner

SSM Health Good Samaritan

Recruiting

Mount Vernon, Illinois, United States, 62864

Contacts

Principal Investigator:

Jay W. Carlson

Carle BroMenn Medical Center

Recruiting

Normal, Illinois, United States, 61761

Contacts

Principal Investigator:

Maria T. Grosse-Perdekamp

Carle Cancer Institute Normal

Recruiting

Normal, Illinois, United States, 61761

Contacts

Principal Investigator:

Maria T. Grosse-Perdekamp

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

Northwestern Medicine Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Principal Investigator:

Shira N. Dinner

Advocate Children's Hospital-Park Ridge

Recruiting

Park Ridge, Illinois, United States, 60068

Contacts

Principal Investigator:

Rebecca E. McFall

Memorial Hospital East

Recruiting

Shiloh, Illinois, United States, 62269

Contacts

Principal Investigator:

Nancy L. Bartlett

Saint John's Hospital

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Principal Investigator:

Gregory P. Brandt

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

217-545-7929

Principal Investigator:

Gregory P. Brandt

Northwestern Medicine Cancer Center Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Principal Investigator:

Shira N. Dinner

Indiana University/Melvin and Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Site Public Contact

317-278-5632iutrials@iu.edu

Principal Investigator:

Tarah J. Ballinger

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Site Public Contact

800-248-1199

Principal Investigator:

Amanda Saraf

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Recruiting

Ankeny, Iowa, United States, 50023

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Saint Anthony Regional Hospital

Recruiting

Carroll, Iowa, United States, 51401

Contacts

Principal Investigator:

Seema Harichand-Herdt

Mercy Cancer Center-West Lakes

Recruiting

Clive, Iowa, United States, 50325

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Recruiting

Clive, Iowa, United States, 50325

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Greater Regional Medical Center

Recruiting

Creston, Iowa, United States, 50801

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

Blank Children's Hospital

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Principal Investigator:

Samantha L. Mallory

Iowa Methodist Medical Center

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-6727

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Broadlawns Medical Center

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-282-2200

Principal Investigator:

Seema Harichand-Herdt

Mercy Medical Center - Des Moines

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

UI Health Care Mission Cancer and Blood - Laurel Clinic

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

UI Healthcare Mission Cancer and Blood - Fort Dodge

Recruiting

Fort Dodge, Iowa, United States, 50501

Contacts

Principal Investigator:

Seema Harichand-Herdt

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

UI Healthcare Mission Cancer and Blood - Pella

Recruiting

Pella, Iowa, United States, 50219

Contacts

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Waukee Clinic

Recruiting

Waukee, Iowa, United States, 50263

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Mercy Medical Center-West Lakes

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

The Iowa Clinic PC

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

Site Public Contact

515-875-9815

Principal Investigator:

Seema Harichand-Herdt

Central Care Cancer Center - Garden City

Recruiting

Garden City, Kansas, United States, 67846

Contacts

Principal Investigator:

Jay W. Carlson

Central Care Cancer Center - Great Bend

Recruiting

Great Bend, Kansas, United States, 67530

Contacts

Principal Investigator:

Jay W. Carlson

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:

Ashley M. Jean

MaineHealth Maine Medical Center- Scarborough

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Principal Investigator:

Ashley M. Jean

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

Christiana Care - Union Hospital

Recruiting

Elkton, Maryland, United States, 21921

Contacts

Principal Investigator:

Gregory A. Masters

C S Mott Children's Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Site Public Contact

800-865-1125

Principal Investigator:

Emily B. Walling

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Emily B. Walling

Bronson Battle Creek

Recruiting

Battle Creek, Michigan, United States, 49017

Contacts

Principal Investigator:

Kathleen Y. Butler

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Principal Investigator:

Kathleen Y. Butler

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

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Principal Investigator:

Kathleen Y. Butler

Trinity Health Grand Rapids 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

West Michigan Cancer Center

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Principal Investigator:

Kathleen Y. Butler

Beacon Kalamazoo Cancer Center

Recruiting

Kalamazoo, Michigan, United States, 49009

Contacts

Site Public Contact

574-647-7370

Principal Investigator:

Kathleen Y. Butler

Beacon Kalamazoo

Recruiting

Kalamazoo, Michigan, United States, 49048

Contacts

Site Public Contact

574-647-7370

Principal Investigator:

Kathleen Y. Butler

Trinity Health Muskegon Hospital

Recruiting

Muskegon, Michigan, United States, 49444

Contacts

Principal Investigator:

Kathleen Y. Butler

Corewell Health Lakeland Hospitals - Niles Hospital

Recruiting

Niles, Michigan, United States, 49120

Contacts

Site Public Contact

616-391-1230

Principal Investigator:

Kathleen Y. Butler

Corewell Health Reed City Hospital

Recruiting

Reed City, Michigan, United States, 49677

Contacts

Principal Investigator:

Kathleen Y. Butler

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Recruiting

Saint Joseph, Michigan, United States, 49085

Contacts

Principal Investigator:

Kathleen Y. Butler

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Recruiting

Saint Joseph, Michigan, United States, 49085

Contacts

Principal Investigator:

Kathleen Y. Butler

Munson Medical Center

Recruiting

Traverse City, Michigan, United States, 49684

Contacts

Principal Investigator:

Kathleen Y. Butler

University of Michigan Health - West

Recruiting

Wyoming, Michigan, United States, 49519

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:

Karim T. Sadak

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Site Public Contact

601-815-6700

Principal Investigator:

Amanda Strobel

Mercy Oncology and Hematology - Clayton-Clarkson

Recruiting

Ballwin, Missouri, United States, 63011

Contacts

Site Public Contact

888-446-3729

Principal Investigator:

Jay W. Carlson

Central Care Cancer Center - Bolivar

Recruiting

Bolivar, Missouri, United States, 65613

Contacts

Principal Investigator:

Jay W. Carlson

Cox Cancer Center Branson

Recruiting

Branson, Missouri, United States, 65616

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

Mercy Cancer Center - Cape Girardeau

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

888-446-3729

Principal Investigator:

Jay W. Carlson

Siteman Cancer Center at Saint Peters Hospital

Recruiting

City of Saint Peters, Missouri, United States, 63376

Contacts

Principal Investigator:

Nancy L. Bartlett

Siteman Cancer Center at West County Hospital

Recruiting

Creve Coeur, Missouri, United States, 63141

Contacts

Principal Investigator:

Nancy L. Bartlett

Freeman Health System

Recruiting

Joplin, Missouri, United States, 64804

Contacts

Principal Investigator:

Jay W. Carlson

Mercy Hospital Joplin

Recruiting

Joplin, Missouri, United States, 64804

Contacts

Principal Investigator:

Jay W. Carlson

Children's Mercy Hospitals and Clinics

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Principal Investigator:

Keith J. August

Lake Regional Hospital

Recruiting

Osage Beach, Missouri, United States, 65065

Contacts

Principal Investigator:

Jay W. Carlson

Mercy Clinic-Rolla-Cancer and Hematology

Recruiting

Rolla, Missouri, United States, 65401

Contacts

Site Public Contact

573-458-6379

Principal Investigator:

Jay W. Carlson

Phelps Health Delbert Day Cancer Institute

Recruiting

Rolla, Missouri, United States, 65401

Contacts

Principal Investigator:

Jay W. Carlson

Heartland Regional Medical Center

Recruiting

Saint Joseph, Missouri, United States, 64506

Contacts

Principal Investigator:

Jay W. Carlson

Mercy Hospital Springfield

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

CoxHealth South Hospital

Recruiting

Springfield, Missouri, United States, 65807

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

Mercy Infusion Center - Chippewa

Recruiting

St Louis, Missouri, United States, 63109

Contacts

Site Public Contact

888-446-3729

Principal Investigator:

Jay W. Carlson

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Nancy L. Bartlett

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Principal Investigator:

Jay W. Carlson

Siteman Cancer Center-South County

Recruiting

St Louis, Missouri, United States, 63129

Contacts

Principal Investigator:

Nancy L. Bartlett

Siteman Cancer Center at Christian Hospital

Recruiting

St Louis, Missouri, United States, 63136

Contacts

Principal Investigator:

Nancy L. Bartlett

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Jay W. Carlson

Mercy Hospital Washington

Recruiting

Washington, Missouri, United States, 63090

Contacts

Site Public Contact

636-390-1600

Principal Investigator:

Jay W. Carlson

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

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Principal Investigator:

Jill C. Beck

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Site Public Contact

551-996-2897

Principal Investigator:

Burton E. Appel

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

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

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator:

Nobuko Hijiya

NYP/Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-746-1848

Principal Investigator:

Alexander J. Chou

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

John L. Mariano

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

Montefiore Medical Center - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

Principal Investigator:

Alice Lee

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Thomas B. Alexander

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 Bismarck Medical Center

Recruiting

Bismarck, North Dakota, United States, 58501

Contacts

Principal Investigator:

Samuel J. Milanovich

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

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator:

Matteo M. Trucco

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

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Rene Y. McNall-Knapp

Mercy Hospital Oklahoma City

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Contacts

Site Public Contact

405-752-3402

Principal Investigator:

Jay W. Carlson

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Site Public Contact

503-494-1080trials@ohsu.edu

Principal Investigator:

Susan J. Lindemulder

Christiana Care Health System-Concord Health Center

Recruiting

Chadds Ford, Pennsylvania, United States, 19317

Contacts

Principal Investigator:

Gregory A. Masters

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:

Rebecca Citrin

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:

Jean M. Tersak

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Site Public Contact

401-444-1488

Principal Investigator:

Bradley DeNardo

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

Anca Dumitriu

Prisma Health Richland Hospital

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Principal Investigator:

Stuart L. Cramer

Sanford USD Medical Center - Sioux Falls

Recruiting

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

Contacts

Principal Investigator:

Jordan Fritch-Hanson

Saint Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Principal Investigator:

Kari Bjornard

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:

Elizabeth J. Davis

Medical City Dallas Hospital

Recruiting

Dallas, Texas, United States, 75230

Contacts

Site Public Contact

972-566-5588

Principal Investigator:

Maurizio L. Ghisoli

Parkland Memorial Hospital

Recruiting

Dallas, Texas, United States, 75235

Contacts

Principal Investigator:

Ksenya Shliakhtsitsava

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Ksenya Shliakhtsitsava

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:

Karen H. Albritton

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:

Stephanie Fetzko

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Najat C. Daw

Children's Hospital of San Antonio

Recruiting

San Antonio, Texas, United States, 78207

Contacts

Principal Investigator:

Julie Voeller

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

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Eric J. Chow

University of Washington Medical Center - Montlake

Recruiting

Seattle, Washington, United States, 98195

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Eric J. Chow

Providence Sacred Heart Medical Center and Children's Hospital

Recruiting

Spokane, Washington, United States, 99204

Contacts

Principal Investigator:

Judy L. Felgenhauer

Madigan Army Medical Center

Recruiting

Tacoma, Washington, United States, 98431

Contacts

Principal Investigator:

Melissa A. Forouhar

Saint Vincent Hospital Cancer Center Green Bay

Recruiting

Green Bay, Wisconsin, United States, 54301

Contacts

Principal Investigator:

Catherine A. Long

Saint Vincent Hospital Cancer Center at Saint Mary's

Recruiting

Green Bay, Wisconsin, United States, 54303

Contacts

Principal Investigator:

Catherine A. Long

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Recruiting

Madison, Wisconsin, United States, 53718

Contacts

Principal Investigator:

Cathy A. Lee-Miller

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:

Kerri Becktell

Aurora Sinai Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53233

Contacts

Principal Investigator:

Rebecca E. McFall

Saint Vincent Hospital Cancer Center at Oconto Falls

Recruiting

Oconto Falls, Wisconsin, United States, 54154

Contacts

Principal Investigator:

Catherine A. Long

Saint Vincent Hospital Cancer Center at Sheboygan

Recruiting

Sheboygan, Wisconsin, United States, 53081

Contacts

Principal Investigator:

Catherine A. Long

Sheboygan Physicians Group

Recruiting

Sheboygan, Wisconsin, United States, 53081

Contacts

Principal Investigator:

Catherine A. Long

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Recruiting

Sturgeon Bay, Wisconsin, United States, 54235-1495

Contacts

Principal Investigator:

Catherine A. Long

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Principal Investigator:

Stephanie M. Villeneuve

The Montreal Children's Hospital of the MUHC

Recruiting

Montreal, Quebec, Canada, H3H 1P3

Contacts

Principal Investigator:

Stephanie Mourad

Centre Hospitalier Universitaire Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Principal Investigator:

Monia Marzouki

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Principal Investigator:

Josee Brossard

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

Recruiting

Québec, Canada, G1V 4G2

Contacts

Principal Investigator:

Bruno Michon

More Information

Sponsor

Children's Oncology Group

Last update posted

Aug 31, 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 Children's Oncology Group on 2026-08-31.