Natural History and Biology of Long-Term Late Effects Following Hematopoietic Cell Transplant for Childhood Hematologic Malignancies
NCT ID: NCT02338479
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
340 participants
OBSERVATIONAL
2015-03-31
2023-12-31
Brief Summary
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Detailed Description
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The study examines the hypothesis that survivors of pediatric HCT are at risk for late organ toxicity and they will have identifiable biomarkers present within the first two years following HCT which will be predictive for late adverse outcomes allowing for early identification of patients at risk.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Planned allogeneic HCT from any donor and stem cell source. There are no study-specific criteria for HLA-matching
3. Disease and disease status criteria
1. Acute lymphoblastic leukemia/lymphoma in complete morphologic remission defined as a M1 marrow (\<5% blasts) with no evidence of active extramedullary disease within 30 days of the start of the conditioning regimen; OR
2. Myelodysplasia (regardless of subtype) with less than 10% marrow blasts within 30 days of the start of the conditioning regimen; OR
3. Acute myelogenous leukemia in complete morphologic remission defined as an M1 marrow (\<5% blasts) with no evidence of extramedullary disease within 30 days of the start of the conditioning regimen; OR
4. Juvenile myelomonocytic leukemia; OR
5. Chronic myelogenous leukemia excluding refractory blast crisis.
4. Planned myeloablative conditioning regimen, defined as a regimen including one of the following as a backbone agent:
1. Busulfan ≥ 12.8 mg/kg total dose (IV or PO). PK-based dosing allowed, if the intent is total overall dose ≥ 12.8 mg/kg; OR
2. Total Body Irradiation ≥ 1200 cGy fractionated; OR
3. Treosulfan ≥ 30 g/m2 total dose IV
5. Enrollment in the following NMDP research protocols:
1. Protocol for a Research Database for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxicity Injuries
2. Protocol for a Research Sample Repository for Allogeneic Hematopoietic Stem Cell Transplantation and Marrow Toxic Injuries
6. Written informed consent document signed by patient if the age is greater than or equal to 18 years and the patient is developmentally able to provide consent. The informed consent document is to be signed by the parent or legal guardian if the patient's age is less than 18 years or if the patient is older than 18 years, but developmentally unable to provide consent. Assent will be obtained according to the guidelines of the patient's transplant institution.
Exclusion Criteria
2. Patients with renal disease prior to the start of HCT conditioning requiring the use of dialysis at the time of enrollment and/or GFR \< 60 mL/min/1.73 m2
3. Patients with osteopenia or osteoporosis treated with a bisphosphonate medication at any time prior to enrollment
4. Patients with preexisting diabetes or hyperglycemia treated with insulin or oral hypoglycemic medication at the time of enrollment
5. Patients with uncontrolled viral, bacterial, fungal or protozoal infection at the time of study enrollment
6. Karnofsky performance score or Lansky Play-Performance Scale Score \<60 at the time of study enrollment
7. Known inherited or constitutional predisposition to cancer including, but not limited to Down Syndrome, Li-Fraumeni syndrome, Fanconi Anemia, and patients with BRCA1 and BRCA2 mutations
22 Years
ALL
No
Sponsors
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Pediatric Blood and Marrow Transplant Consortium
OTHER
National Marrow Donor Program
OTHER
Center for International Blood and Marrow Transplant Research
NETWORK
Responsible Party
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Principal Investigators
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Christine Duncan, MD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
K. Scott Baker, MD
Role: STUDY_CHAIR
Fred Hutchinson Cancer Center
Locations
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Mayo Clinic
Scottsdale, Arizona, United States
University of Arizona Medical Center
Tucson, Arizona, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
UCLA Center for Health Sciences
Los Angeles, California, United States
Children's Hospital & Research Center - Oakland
Oakland, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
All Children's Hospital
St. Petersburg, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Indiana University Hospital/Riley Hospital for Children
Indianapolis, Indiana, United States
Dana Farber Cancer Institute - Pediatrics
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
The Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
Washington University/St. Louis Children's Hospital
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Westchester Medical Center
Valhalla, New York, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
Duke University Medical Center - Pediatrics
Durham, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health and Science University - Doernbecher Children's Hospital
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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13-TLEC
Identifier Type: -
Identifier Source: org_study_id
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