Cyclophosphamide and Total Body Irradiation in Treating Patients Who Are Undergoing an Autologous Peripheral Stem Cell Transplant For Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: German CLL Study Group
• Treatments: Carmustine; Cyclophosphamide; Cytarabine; Dexamethasone; Etoposide; Fludarabine; Fludarabine phosphate; Melphalan

Criteria

DISEASE CHARACTERISTICS:

• Patients with chronic lymphocytic leukemia, meeting 1 of the following criteria:

• Binet stage B or C disease

• Binet stage A disease and at high risk for disease progression, defined as the following:

• Non-nodular marrow infiltration or lymphocyte doubling time < 12 months

• Thymidine kinase > 7.0 U/L or ß-2-microglobulin > 3.5 mg/L

• Polymerase chain reaction-amplifiable clonal CDRIII rearrangement of the IgV_H

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• No concurrent disease resulting in major organ dysfunction

PRIOR CONCURRENT THERAPY:

• No prior combination therapy comprising melphalan, dexamethasone, carmustine, cytarabine, and etoposide (DEXA-Beam)

• No more than 1 prior chemotherapy regimen

• No prior chemotherapy regimen longer than 6 months in duration