Recruiting

Observational Study

Sponsor:

Children's Oncology Group

Code:

NCT05702645

Conditions

B Acute Lymphoblastic Leukemia Associated With Down Syndrome

Down Syndrome

Myeloid Leukemia Associated With Down Syndrome

Eligibility Criteria

Sex: All

Age: 6 - 39

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Clinical Evaluation

Neurocognitive Assessment

Questionnaire Administration

Survey Administration

Study Details

Brief summary:

This study attempts to learn more about the health of persons with Down syndrome after treatment for acute leukemia. Children with Down syndrome are at increased risk for side effects during treatment for acute leukemia, but it is unclear of their risk for long-term effects of cancer treatment. By learning more about the factors that may contribute to chronic health conditions and long-term effects after treatment for leukemia in persons with Down syndrome, clinical practice guidelines for survivorship care can be developed to help improve their quality-of-life.

Conditions

B Acute Lymphoblastic Leukemia Associated With Down Syndrome

Down Syndrome

Myeloid Leukemia Associated With Down Syndrome

Study ID

NCT05702645

Start date

Nov 30, 2023

Status verified date

Apr, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 39

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients age >= 6 and < 40 years at the time of enrollment
  • A diagnosis of Down syndrome is required, and may include any of the three recognized types: trisomy 21 resulting from chromosomal nondisjunction (most common), translocation (the patient has 46 chromosomes, but all or part of an additional copy of chromosome 21 is attached to another chromosome), or mosaicism (trisomy 21 that is present in only a fraction of cells)
  • All patients must be DS-AL survivors (acute lymphoblastic leukemia \[ALL\] or acute myeloid leukemia \[AML\])

  • Note 1: Myeloid leukemia of Down syndrome (ML-DS) is included in the AML category above. Per the World Health Organization (WHO) definition of ML-DS, this diagnosis encompasses both myelodysplastic syndrome (MDS) and overt AML. Also, note that survivors of relapsed disease are eligible, so long as the patient otherwise meets eligibility criteria, i.e., treatment for relapse was completed at least 36 calendar months prior to enrollment and did not include stem cell transplant
  • Note 2: A diagnosis of transient abnormal myelopoiesis (TAM), also known as transient myeloproliferative disease (TMD), is not alone sufficient for inclusion in this study
  • Patients must have been treated for ALL or AML

  • Note: History of COG therapeutic trial participation is not required. As a reminder ML-DS would be included under the AML category here above
  • All cancer treatment (oral or intravenous) must have been completed at least 36 calendar months prior to enrollment
  • Patients must have a life expectancy of > 1 year
  • Patient and parent of subject must be either English or Spanish speaking. At least one parent or guardian must be able to read and write in English or Spanish

  • Note: Parents or guardians are responsible for completing all questionnaires, even in the case of subjects that are >= 18 years old
  • 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:

  • Patients with history of hematopoietic stem cell transplant (HSCT) are excluded

  • Note: Patients with previous chimeric antigen receptor T-cell (CAR T-cell) therapy, and other cellular cancer therapies can participate, as long as all other eligibility criteria are satisfied
  • Patients with a history of cancers prior to their ALL or AML diagnosis are excluded. Patients that developed a subsequent malignant neoplasm following their ALL or AML diagnosis are also excluded

  • Note: Prior history of transient abnormal myelopoiesis is allowed, but is not sufficient for eligibility
  • Patients whose parents or guardians are unable to complete the required forms are excluded

Study Design

Enrollment

330 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (biospecimen collection, clinical evaluation)

Patients undergo an optional saliva/buccal swab in part 1 and clinical assessment in part 2 of the study. Patients with DS-ALL may then undergo blood sample collection and neurocognitive assessment in part 3 of the study.

Interventions

Biospecimen Collection

Patients undergo saliva/buccal and blood sample collection

Clinical Evaluation

Undergo a clinical assessment

Neurocognitive Assessment

Undergo neurocognitive assessment

Questionnaire Administration

Ancillary studies

Survey Administration

Ancillary studies

Primary outcome measure

  • Prevalence, type, and severity of chronic health conditions (CHC) [ Time Frame: Up to study completion ]

Central Contacts and Locations

Locations

Children's Hospital of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Site Public Contact

205-638-9285oncologyresearch@peds.uab.edu

Principal Investigator:

Smita Bhatia

Phoenix Childrens Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Site Public Contact

602-546-0920

Principal Investigator:

Alexandra M. Walsh

Valley Children's Hospital

Recruiting

Madera, California, United States, 93636

Contacts

Site Public Contact

559-353-3000Research@valleychildrens.org

Principal Investigator:

Ruetima Titapiwatanakun

UCSF Benioff Children's Hospital Oakland

Recruiting

Oakland, California, United States, 94609

Contacts

Site Public Contact

510-428-3264PedOncRschOAK@ucsf.edu

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

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

Site Public Contact

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Karen R. Rabin

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Rozalyn L. Rodwin

Alfred I duPont Hospital for Children

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Site Public Contact

302-651-5572Allison.bruce@nemours.org

Principal Investigator:

Vibhuti Agarwal

Golisano Children's Hospital of Southwest Florida

Recruiting

Fort Myers, Florida, United States, 33908

Contacts

Site Public Contact

239-343-5333molly.arnstrom@leehealth.org

Principal Investigator:

Emad K. Salman

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

Site Public Contact

302-651-5572Allison.bruce@nemours.org

Principal Investigator:

Vibhuti Agarwal

Nemours Children's Hospital

Recruiting

Orlando, Florida, United States, 32827

Contacts

Site Public Contact

302-651-5572Allison.bruce@nemours.org

Principal Investigator:

Vibhuti Agarwal

Nemours Children's Clinic - Pensacola

Recruiting

Pensacola, Florida, United States, 32504

Contacts

Site Public Contact

helpdesk@childrensoncologygroup.org

Principal Investigator:

Jeffrey H. Schwartz

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

Recruiting

Tampa, Florida, United States, 33607

Contacts

Site Public Contact

813-357-0849jennifer.manns@baycare.org

Principal Investigator:

Don E. Eslin

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Site Public Contact

404-785-0232Olivia.Floyd@choa.org

Principal Investigator:

Karen E. Effinger

Augusta University Medical Center

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Site Public Contact

706-721-2388ga_cares@augusta.edu

Principal Investigator:

Colleen H. McDonough

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

Lurie Children's Hospital-Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

773-880-4562

Principal Investigator:

Lindsay F. Schwartz

University of Chicago Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Site Public Contact

773-702-8222cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Gabrielle Lapping-Carr

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Site Public Contact

410-601-9083

Principal Investigator:

Jason M. Fixler

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

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Site Public Contact

helpdesk@childrensoncologygroup.org

Principal Investigator:

Alissa M. Martin

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

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Bronson Methodist Hospital

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Children's Hospitals and Clinics of Minnesota - Minneapolis

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Site Public Contact

612-813-5913pauline.mitby@childrensmn.org

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

Children's Mercy Hospitals and Clinics

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Site Public Contact

816-302-6808COGResearchGroup@cmh.edu

Principal Investigator:

Keith J. August

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Robert J. Hayashi

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

Site Public Contact

402-559-6941unmcrsa@unmc.edu

Principal Investigator:

Jill C. Beck

University Medical Center of Southern Nevada

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Site Public Contact

702-384-0013research@sncrf.org

Principal Investigator:

Alan K. Ikeda

Sunrise Hospital and Medical Center

Recruiting

Las Vegas, Nevada, United States, 89109

Contacts

Site Public Contact

702-384-0013research@sncrf.org

Principal Investigator:

Alan K. Ikeda

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Recruiting

Las Vegas, Nevada, United States, 89135

Contacts

Site Public Contact

702-384-0013research@sncrf.org

Principal Investigator:

Alan K. Ikeda

Summerlin Hospital Medical Center

Recruiting

Las Vegas, Nevada, United States, 89144

Contacts

Site Public Contact

702-384-0013research@sncrf.org

Principal Investigator:

Alan K. Ikeda

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Contacts

Site Public Contact

775-982-5050Renown-CRD@renown.org

Principal Investigator:

Alan K. Ikeda

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Site Public Contact

551-996-2897

Principal Investigator:

Katharine R. Lange

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

Site Public Contact

800-767-9355askroswell@roswellpark.org

Principal Investigator:

Denise A. Rokitka

Montefiore Medical Center - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

Site Public Contact

718-379-6866eskwak@montefiore.org

Principal Investigator:

Alice Lee

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Site Public Contact

877-668-0683cancerclinicaltrials@med.unc.edu

Principal Investigator:

Thomas B. Alexander

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

Site Public Contact

701-323-5760OncologyClinicalTrialsFargo@sanfordhealth.org

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

Rainbow Babies and Childrens Hospital

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Site Public Contact

216-844-5437

Principal Investigator:

Duncan S. Stearns

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Site Public Contact

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Matteo M. Trucco

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Site Public Contact

614-722-6039Melinda.Triplet@nationwidechildrens.org

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

Site Public Contact

405-271-8777ou-clinical-trials@ouhsc.edu

Principal Investigator:

Rene Y. McNall-Knapp

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

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Site Public Contact

267-425-5544CancerTrials@email.chop.edu

Principal Investigator:

Sogol Mostoufi-Moab

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Site Public Contact

412-692-8570jean.tersak@chp.edu

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

Prisma Health Richland Hospital

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Stuart L. Cramer

BI-LO Charities Children's Cancer Center

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Aniket Saha

Sanford USD Medical Center - Sioux Falls

Recruiting

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

Contacts

Site Public Contact

605-312-3320OncologyClinicalTrialsSF@SanfordHealth.org

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

Saint Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Site Public Contact

888-226-4343referralinfo@stjude.org

Principal Investigator:

Lisa Jacola

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Site Public Contact

800-811-8480

Principal Investigator:

Debra L. Friedman

Dell Children's Medical Center of Central Texas

Recruiting

Austin, Texas, United States, 78723

Contacts

Site Public Contact

512-628-1902TXAUS-DL-SFCHemonc.research@ascension.org

Principal Investigator:

Shannon M. Cohn

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Site Public Contact

214-648-7097canceranswerline@UTSouthwestern.edu

Principal Investigator:

Ksenya Shliakhtsitsava

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Site Public Contact

682-885-2103CookChildrensResearch@cookchildrens.org

Principal Investigator:

Donald T. Beam

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:

Omar Shakeel

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

866-632-6789askmdanderson@mdanderson.org

Principal Investigator:

Najat C. Daw

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Site Public Contact

210-450-3800phoresearchoffice@uthscsa.edu

Principal Investigator:

Shafqat Shah

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

Site Public Contact

800-228-6618HopeBeginsHere@providence.org

Principal Investigator:

Judy L. Felgenhauer

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Site Public Contact

800-622-8922clinicaltrials@cancer.wisc.edu

Principal Investigator:

Cathy A. Lee-Miller

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Michelle A. Manalang

Children's Hospital of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-955-4727MACCCTO@mcw.edu

Principal Investigator:

Rachel A. Phelan

Children's Hospital

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Site Public Contact

519-685-8306

Principal Investigator:

Shayna M. Zelcer

More Information

Sponsor

Children's Oncology Group

Last update posted

Aug 25, 2026

Last verified

Apr, 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 2026-08-25.