Pivotal Study for High Dose Therapy and Autologous Stem Cell Transplantation in Early Stages of CLL
- Determine the safety and feasibility of autologous peripheral blood stem cell
transplantation in patients with chronic lymphocytic leukemia treated with
cyclophosphamide and total-body irradiation.
- Determine the safety, feasibility, and efficacy of combination therapy comprising
dexamethasone, carmustine, cytarabine, etoposide, and melphalan (Dexa-BEAM) and
filgrastim (G-CSF) mobilization in patients treated with this regimen.
- Determine the efficacy of ex-vivo graft purging in patients treated with this regimen.
- Determine the incidence of complete clinical and molecular remissions in patients
treated with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
OUTLINE: This is a multicenter, open-label, nonrandomized study.
- Cytoreductive treatment: Patients undergo 2-4 courses of cytoreductive treatment,
preferably following the fludarabine and cyclophosphamide (FC) protocol.
- Stem cell mobilization: Patients achieving a complete remission (CR) or partial
remission (PR) and stable blood counts undergo stem cell mobilization comprising
dexamethasone, carmustine, cytarabine, etoposide, melphalan (Dexa-BEAM), and filgrastim
(G-CSF). Patients with an adequate number of mobilized cells undergo stem cell
collection. Patients with CR or very good PR proceed to myeloablative therapy.
- Myeloablative therapy: Patients undergo total-body irradiation on day -4 and receive
cyclophosphamide IV on days -4 and -3.
- Autologous peripheral blood stem cell transplantation (PBSCT): Patients undergo
autologous PBSCT on day 0.
After completion of study, patients are followed periodically.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Safety of autologous peripheral stem cell transplantation (PBSCT) as measured by a treatment-related mortality of < 5% at 12 months following transplant
United States: Federal Government