drugset / Trial / NCT00276809

Combination Chemotherapy, Total-Body Irradiation, and Alemtuzumab in Treating Patients Undergoing an Autologous Stem Cell Transplant for Stage I, Stage II, Stage III, or Stage IV Chronic Lymphocytic Leukemia

NCT00276809

Phase 2 Completed 30 enrolled German CLL Study Group
Non-randomizedOpen-labelTreatment

Summary

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.

Timeline

Start
2001-06
Primary completion
2004-09
Completion
2004-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Alemtuzumab Monoclonal antibody Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Cytarabine Small molecule Intravenous
Background Dexamethasone Small molecule Oral
Background Etoposide Small molecule Intravenous
Background Fludarabine Small molecule Intravenous
Background Melphalan Small molecule Intravenous
Background carmustine Small molecule Intravenous
Background filgrastim Protein / enzyme biologic Subcutaneous