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
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
PRIMARY OBJECTVES: I. To evaluate regimen related toxicity, engraftment and graft versus host disease (GVHD) in the first 100 days with new reduced intensity haploidentical regimen protocol, including fludarabine (fludarabine phosphate), low dose total body irradiation, and cyclophosphamide. II. To determine an effective donor lymphocyte infusion (DLI) dose that provides successful engraftment without causing GVHD. SECONDARY OBJECTIVES: I. To assess myeloid and lymphoid engraftment rates of patients undergoing treatment on this regimen. II. To determine the incidence and severity of GVHD in patients undergoing treatment on this regimen using a combination of tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis. III. To examine progression free survival and overall survival in patients with cytotoxic T-cell lymphoma (CTCL) undergoing treatment on this regimen. IV. To assess the pace of lymphoid recovery in this patient population. OUTLINE: This is a phase I, dose-escalation study of DLI. REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -11 to -8 and undergo total body irradiation twice daily (BID) on day -7. Patients also receive donor cluster of differentiation (CD)3+ enriched T lymphocyte infusion on day -6 and high-dose cyclophosphamide IV over 2 hours on days -3 to -2. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant (PBSCT) on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV with taper (drug wean) by day 60 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD. After completion of treatment, patients are followed up periodically.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
