Chronic Lymphocytic Leukemia Clinical Trial

A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia

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.

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Full Description

PRIMARY OBJECTIVE:

I. To determine the prevalence, type, and severity of chronic health conditions (CHC) in survivors of Down syndrome-associated acute leukemia (DS-AL), and to compare CHC with frequency-matched DS individuals that have no cancer history.

SECONDARY OBJECTIVES:

I. To characterize post-treatment clinical outcomes of DS-AL by prospective, in-person assessment.

II. To determine the prevalence and severity of parent-reported neuropsychological (NP) in survivors of DS-AL, compared with frequency-matched DS individuals with no cancer history.

III. To determine health-related quality of life (HRQOL) in survivors of DS-AL, compared with frequency-matched DS individuals with no cancer history.

IV. To identify clinical risk determinants of CHC, NP, and clinical outcomes in survivors of DS-AL.

V. To establish a well-annotated cohort of survivors of DS-AL and associated biobank as a resource for future investigations.

EXPLORATORY OBJECTIVES:

I. For DS-acute lymphoblastic leukemia (DS-ALL), test if structural birth defects and genetic associations with etiology extend to CHC.

II. For DS-ALL, test if telomere length determined by polygenic risk score and telomere flow-fluorescence in situ hybridization (FISH) are associated with outcomes from in-person NP assessment.

OUTLINE:

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

View Eligibility Criteria

Eligibility Criteria

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: Myeloid leukemia of Down syndrome (ML-DS) would be included under AML category above. 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

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 forms, 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 is for people with:

Chronic Lymphocytic Leukemia

Estimated Enrollment:

330

Study ID:

NCT05702645

Recruitment Status:

Recruiting

Sponsor:

Children's Oncology Group

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There are 34 Locations for this study

See Locations Near You

Valley Children's Hospital
Madera California, 93636, United States More Info
Site Public Contact
Contact
559-353-3000
[email protected]
Karen S. Fernandez
Principal Investigator
UCSF Benioff Children's Hospital Oakland
Oakland California, 94609, United States More Info
Site Public Contact
Contact
510-428-3264
[email protected]
Jennifer G. Michlitsch
Principal Investigator
UCSF Medical Center-Mission Bay
San Francisco California, 94158, United States More Info
Site Public Contact
Contact
877-827-3222
[email protected]
Anya Levinson
Principal Investigator
Alfred I duPont Hospital for Children
Wilmington Delaware, 19803, United States More Info
Site Public Contact
Contact
302-651-5572
[email protected]
Ramamoorthy Nagasubramanian
Principal Investigator
Golisano Children's Hospital of Southwest Florida
Fort Myers Florida, 33908, United States More Info
Site Public Contact
Contact
239-343-5333
[email protected]
Emad K. Salman
Principal Investigator
Nemours Children's Clinic-Jacksonville
Jacksonville Florida, 32207, United States More Info
Site Public Contact
Contact
302-651-5572
[email protected]
Ramamoorthy Nagasubramanian
Principal Investigator
Nemours Children's Hospital
Orlando Florida, 32827, United States More Info
Site Public Contact
Contact
302-651-5572
[email protected]
Ramamoorthy Nagasubramanian
Principal Investigator
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa Florida, 33607, United States More Info
Site Public Contact
Contact
813-357-0849
[email protected]
Don E. Eslin
Principal Investigator
Children's Healthcare of Atlanta - Egleston
Atlanta Georgia, 30322, United States More Info
Site Public Contact
Contact
404-785-2025
[email protected]
Karen E. Effinger
Principal Investigator
C S Mott Children's Hospital
Ann Arbor Michigan, 48109, United States More Info
Site Public Contact
Contact
800-865-1125
Joshua W. Goldman
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Robert J. Hayashi
Principal Investigator
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
Alan K. Ikeda
Principal Investigator
Sunrise Hospital and Medical Center
Las Vegas Nevada, 89109, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
Alan K. Ikeda
Principal Investigator
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas Nevada, 89135, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
Alan K. Ikeda
Principal Investigator
Summerlin Hospital Medical Center
Las Vegas Nevada, 89144, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
Alan K. Ikeda
Principal Investigator
Renown Regional Medical Center
Reno Nevada, 89502, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
Alan K. Ikeda
Principal Investigator
Albany Medical Center
Albany New York, 12208, United States More Info
Site Public Contact
Contact
518-262-5513
Lauren R. Weintraub
Principal Investigator
Montefiore Medical Center - Moses Campus
Bronx New York, 10467, United States More Info
Site Public Contact
Contact
718-379-6866
[email protected]
Alice Lee
Principal Investigator
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States More Info
Site Public Contact
Contact
336-713-6771
Thomas W. McLean
Principal Investigator
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States More Info
Site Public Contact
Contact
701-323-5760
[email protected]
Samuel J. Milanovich
Principal Investigator
Dayton Children's Hospital
Dayton Ohio, 45404, United States More Info
Site Public Contact
Contact
800-228-4055
Mukund G. Dole
Principal Investigator
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States More Info
Site Public Contact
Contact
405-271-8777
[email protected]
Rene Y. McNall-Knapp
Principal Investigator
Oregon Health and Science University
Portland Oregon, 97239, United States More Info
Site Public Contact
Contact
503-494-1080
[email protected]
Susan J. Lindemulder
Principal Investigator
Children's Hospital of Pittsburgh of UPMC
Pittsburgh Pennsylvania, 15224, United States More Info
Site Public Contact
Contact
412-692-8570
[email protected]
Jean M. Tersak
Principal Investigator
Rhode Island Hospital
Providence Rhode Island, 02903, United States More Info
Site Public Contact
Contact
401-444-1488
Jennifer J. Welch
Principal Investigator
BI-LO Charities Children's Cancer Center
Greenville South Carolina, 29605, United States More Info
Site Public Contact
Contact
864-241-6251
Aniket Saha
Principal Investigator
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States More Info
Site Public Contact
Contact
605-312-3320
[email protected]
Kayelyn J. Wagner
Principal Investigator
East Tennessee Childrens Hospital
Knoxville Tennessee, 37916, United States More Info
Site Public Contact
Contact
865-541-8266
Susan E. Spiller
Principal Investigator
Dell Children's Medical Center of Central Texas
Austin Texas, 78723, United States More Info
Site Public Contact
Contact
512-628-1902
[email protected]
Shannon M. Cohn
Principal Investigator
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States More Info
Site Public Contact
Contact
214-648-7097
[email protected]
Ksenya Shliakhtsitsava
Principal Investigator
Cook Children's Medical Center
Fort Worth Texas, 76104, United States More Info
Site Public Contact
Contact
682-885-2103
[email protected]
Donald T. Beam
Principal Investigator
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston Texas, 77030, United States More Info
Site Public Contact
Contact
713-798-1354
[email protected]
Maria M. Gramatges
Principal Investigator
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Site Public Contact
Contact
877-632-6789
[email protected]
Najat C. Daw
Principal Investigator
Providence Sacred Heart Medical Center and Children's Hospital
Spokane Washington, 99204, United States More Info
Site Public Contact
Contact
800-228-6618
[email protected]
Judy L. Felgenhauer
Principal Investigator
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States More Info
Site Public Contact
Contact
800-782-8581
[email protected]
Jon M. Brandt
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Estimated Enrollment:

330

Study ID:

NCT05702645

Recruitment Status:

Recruiting

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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