Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Fred Hutchinson Cancer Center
With
OBJECTIVES: Primary * Evaluate the potential efficacy of targeting cyclophosphamide to a metabolic endpoint when given together with total-body irradiation, in terms of day 200 nonrelapse mortality, in patients with hematologic cancer and other diseases who are undergoing allogeneic hematopoietic stem cell transplantation. Secondary * Determine the overall survival of patients treated with this regimen. * Determine the rate of relapse in patients treated with this regimen. * Determine the occurrence of sinusoidal obstruction syndrome in patients treated with this regimen. * Determine the occurrence of acute renal failure in these patients. * Determine the occurrence of respiratory failure in these patients. OUTLINE: * Conditioning regimen: Patients undergo total-body irradiation twice daily on days -6 to -4. Patients also receive cyclophosphamide IV over 1 hour on day -3 and then IV at a metabolism-based dose\* on day -2. NOTE: \*Patients undergo frequent blood sampling after completion of the first cyclophosphamide infusion for pharmacokinetic studies in order to determine the dose for the second cyclophosphamide infusion. * Allogeneic stem cell transplantation: Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. * Graft-versus-host disease (GVHD) prophylaxis: Patients receive GVHD prophylaxis as per the attending physician, including one of the following regimens: cyclosporine and methotrexate; tacrolimus and methotrexate; tacrolimus and mycophenolate mofetil; or sirolimus, tacrolimus, and methotrexate (as per the GVHD prophylaxis regimen chosen for each patient). After completion of study treatment, patients are followed periodically for at least 200 days. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
