Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults and Pediatrics
Fred Hutchinson Cancer Center
Summary
This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic diseases. Giving chemotherapy, such as cyclophosphamide, fludarabine and thiotepa, and TBI before a donor cord blood transplant (CBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening in patients with high-risk hematologic diseases.
Description
OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients aged 6 months through 30 years old receive myeloablative conditioning comprising fludarabine intravenously (IV) over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI twice daily (BID) on days -4 to -1. Patients then undergo UCBT on day 0. Patients undergo blood sample collection throughout the study. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) and diagnostic imaging during screening and as clinically indicated on study. Patients also undergo blood samp…
Eligibility
- Age range
- 0–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients aged 6 months to =\< 65 years at time of consent. * Acute myelogenous leukemia (AML): * Complete first remission (CR1), complete second remission (CR2) or greater (CR2+), must have \< 5% marrow blasts at the time of transplant. * Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible. * Acute lymphoblastic leukemia (ALL): * Complete first remission (CR1) at high risk for relapse such as any of the following: * Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19),…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Aspirate
Undergo bone marrow aspirate
- DrugCyclophosphamide
Receive IV
- DrugCyclosporine
Receive IV or PO
- ProcedureDiagnostic Imaging
Undergo diagnostic imaging
- ProcedureEchocardiography
Undergo ECHO
- DrugFludarabine Phosphate
Receive IV
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington