Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Pivotal Study for High Dose Therapy and Autologous Stem Cell Transplantation in Early Stages of CLL
RATIONALE: Giving chemotherapy before a peripheral stem cell transplant stops the growth of
cancer cells by stopping them from dividing or killing them. Giving colony-stimulating
factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone
marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is
then given to prepare the bone marrow for the stem cell transplant. The stem cells are then
returned to the patient to replace the blood-forming cells that were destroyed by the
chemotherapy and radiation therapy.
PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with
total-body irradiation works in treating patients who are undergoing an peripheral stem cell
transplant for chronic lymphocytic leukemia.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
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