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