This is a prospective non-therapeutic study, assessing the long-term toxicity of pediatric HCT for hematologic malignancies. This study is a collaboration between the Pediatric Blood and Marrow Transplant Consortium (PBMTC), the Center for International Blood and Marrow Transplant Research (CIBMTR), the National Marrow Transplant Program (NMDP) and the Resource for Clinical Investigation in Blood and Marrow Transplantation (RCI-BMT) of the CIBMTR. The study will enroll pediatric patients who undergo myeloablative HCT for hematologic malignancies at PBMTC sites.
This is a prospective non-therapeutic study, assessing the long-term toxicity of pediatric HCT for hematologic malignancies. This study is a collaboration between the Pediatric Blood and Marrow Transplant Consortium (PBMTC), the Center for International Blood and Marrow Transplant Research (CIBMTR), the National Marrow Transplant Program (NMDP) and the Resource for Clinical Investigation in Blood and Marrow Transplantation (RCI-BMT) of the CIBMTR. The study will enroll pediatric patients who undergo myeloablative HCT for hematologic malignancies at PBMTC sites. 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.
Study Type
OBSERVATIONAL
Enrollment
340
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
To report the incidence of chronic kidney disease (CKD), metabolic syndrome, and osteopenia
Time frame: Baseline to 1 and 2 years following allogeneic HCT for hematologic malignancy
To identify prognostic risk factors for the development and progression of post-HCT CKD, metabolic syndrome, and osteopenia
Time frame: Baseline to 1 and 2 years following HCT
To investigate potential associations of systemic hypertension as measured with intermittent blood pressure assessment with proteinuria, acute kidney injury, and CKD
Time frame: Baseline to 100 days, and at 1 and 2 years following HCT
To compare the results of GFR estimating equations based on serum cystatin C levels or serum creatinine to GFR measured by nuclear medicine GFR and/or 24-hour creatinine clearance
Time frame: Baseline to 180 days, and at 1 and 2 years following HCT
To explore potential association of the protein biomarker elafin in the urine at with the development of CKD
Time frame: Baseline to 180 days, and at 1 and 2 years following HCT
To report levels of fasting triglycerides, low-density lipoprotein, high-density lipoprotein, insulin, and glucose levels
Time frame: Baseline to 100 days, and at 1 and 2 years following HCT
To assess change in body composition including bone mineral density, body mass index, percent fat mass and lean body mass as measured by dual-energy absorptiometry
Time frame: Baseline to 1 and 2 years following HCT
To assess the presence of osteopenia prior to HCT and at 1-year and 2-years following HCT by x-ray in patients unable to undergo DXA without sedation
Time frame: Baseline to 1 and 2 years following HCT
To report levels of markers of bone turnover including serum osteocalcin, bone specific alkaline phosphatase, and urine N-telopeptide
Time frame: Baseline to 30 days, 100 days, and at 1 and 2 years following HCT
To develop a repository for plasma to be used in future investigation of HCT-associated late effects
Time frame: Baseline, 30 days, 100 days, and at 1 and 2 years following HCT
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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
...and 22 more locations