Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pediatric Blood and Marrow Transplant Consortium | OTHER |
| National Marrow Donor Program | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| To report the incidence of chronic kidney disease (CKD), metabolic syndrome, and osteopenia | Baseline to 1 and 2 years following allogeneic HCT for hematologic malignancy |
| Measure | Description | Time Frame |
|---|---|---|
| To identify prognostic risk factors for the development and progression of post-HCT CKD, metabolic syndrome, and osteopenia | 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 |
Not provided
Inclusion Criteria:
Age less than 22 years at admission for HCT
Planned allogeneic HCT from any donor and stem cell source. There are no study-specific criteria for HLA-matching
Disease and disease status criteria
Planned myeloablative conditioning regimen, defined as a regimen including one of the following as a backbone agent:
Enrollment in the following NMDP research protocols:
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:
Not provided
Not provided
Not provided
This study will enroll is a nonrandomized prospective cohort undergoing HCT for treatment of childhood leukemia and myelodysplasia.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christine Duncan, MD | Dana-Farber Cancer Institute | Study Chair |
| K. Scott Baker, MD | Fred Hutchinson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259-5499 | United States | ||
| University of Arizona Medical Center |
Not provided
Not provided
Not provided
Not provided
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline, 30 days, 100 days, and at 1 and 2 years following HCT |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | United States |
| UCLA Center for Health Sciences | Los Angeles | California | 90095 | United States |
| Children's Hospital & Research Center - Oakland | Oakland | California | 94609 | United States |
| University of California San Francisco Medical Center | San Francisco | California | 94143 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
| Ann and Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60601 | United States |
| Indiana University Hospital/Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Dana Farber Cancer Institute - Pediatrics | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| The Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
| Washington University/St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| University of North Carolina Hospitals | Chapel Hill | North Carolina | 27599 | United States |
| Levine Children's Hospital | Charlotte | North Carolina | 28203 | United States |
| Duke University Medical Center - Pediatrics | Durham | North Carolina | 27705 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Oregon Health and Science University - Doernbecher Children's Hospital | Portland | Oregon | 97239 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37235 | United States |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | United States |
| Texas Transplant Institute | San Antonio | Texas | 78229 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84111 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D015470 | Leukemia, Myeloid, Acute |
| D054429 | Leukemia, Myelomonocytic, Juvenile |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| D007951 | Leukemia, Myeloid |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided