Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Campath 1H (Alemtuzumab) Combined With High-Dose Therapy and Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia
RATIONALE: Giving combination chemotherapy before a peripheral blood 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. A monoclonal
antibody, such as alemtuzumab, is given to kill any remaining cancer cells. Chemotherapy and
radiation therapy (total-body irradiation) are 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. Giving
combination chemotherapy, total-body irradiation, and alemtuzumab together with autologous
peripheral stem cell transplant may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together
with total-body irradiation and alemtuzumab works in treating patients undergoing an
autologous stem cell transplant for stage I, stage II, stage III, or stage IV chronic
lymphocytic leukemia.
OBJECTIVES:
Primary
- Determine the safety and feasibility of cytoreductive fludarabine and cyclophosphamide
followed by high-dose myeloablative therapy comprising total-body irradiation,
cyclophosphamide, and alemtuzumab in patients undergoing autologous filgrastim
(G-CSF)-mobilized peripheral blood stem cell transplantation for stage I-IV chronic
lymphocytic leukemia.
Secondary
- Determine the clinical and molecular remission rate and duration in patients treated
with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter, open label, nonrandomized study. Patients are assigned to 1
of 2 cohorts according to time of enrollment.
- Cytoreductive induction therapy: All patients receive fludarabine IV and
cyclophosphamide IV on days 1-3. Treatment repeats every 28 days for 2-4 courses in the
absence of disease progression or unacceptable toxicity. Patients achieving complete
response (CR) or partial response (PR) proceed to stem cell mobilization. Patients with
stage III or IV disease at this point are removed from study.
- Stem cell mobilization: All patients receive Dexa-BEAM comprising oral dexamethasone
once daily on days 1-10; carmustine IV and melphalan IV on day 2; and cytarabine IV
twice daily and etoposide IV once daily on days 4-7. Patients also receive filgrastim
(G-CSF) subcutaneously beginning on day 8 and continuing until leukapheresis is
completed. Patients undergo peripheral blood stem cell (PBSC) harvest between days 20
and 28. Patients without an adequate number of collected PBSCs may receive a second
course of Dexa-BEAM. Patients achieving CR or very good PR proceed to high-dose
myeloablative therapy and PBSC transplantation (PBSCT) with or without consolidation
therapy.
- Consolidation therapy: Beginning between 1-2 months after completion of Dexa-BEAM,
patients in cohort 2 receive alemtuzumab IV over 2 hours on days 1, 3, 5, 8, 10, 12,
15, 17, 19, 22, 24, and 26 and then proceed to high-dose myeloablative therapy and
PBSCT within 1 month after completion of consolidation therapy. Patients in cohort 1 do
not receive consolidation therapy and proceed directly to high-dose therapy within 3
months after completion of stem cell mobilization.
- High-dose myeloablative therapy and PBSCT: Patients undergo total-body irradiation on
days -7 to -5. Patients then receive cyclophosphamide IV on days -4 and -3 and
alemtuzumab IV over 2 hours on days -10, -9, -8, -6, and -4. Patients undergo PBSCT on
day 0.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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