Natural History and Biology of Long-Term Late Effects Following Hematopoietic Cell Transplant for… (NCT02338479) | Clinical Trial Compass
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Natural History and Biology of Long-Term Late Effects Following Hematopoietic Cell Transplant for Childhood Hematologic Malignancies
United States340 participantsStarted 2015-03
Plain-language summary
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.
Who can participate
Age range22 Years
SexALL
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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
✓. 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
✓. Myelodysplasia (regardless of subtype) with less than 10% marrow blasts within 30 days of the start of the conditioning regimen; OR
✓. 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
✕. 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
✕. Patients with osteopenia or osteoporosis treated with a bisphosphonate medication at any time prior to enrollment
✕. Patients with preexisting diabetes or hyperglycemia treated with insulin or oral hypoglycemic medication at the time of enrollment
✕. Patients with uncontrolled viral, bacterial, fungal or protozoal infection at the time of study enrollment
✕. Karnofsky performance score or Lansky Play-Performance Scale Score \<60 at the time of study enrollment
✕. 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