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

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Chronic lymphocytic leukemia (CLL), meeting 1 of the following stage criteria:

• Stage I-IV disease

• Binet stage B or C disease

• Binet stage A disease at high risk for rapid disease progression, as defined by both of the following criteria:

• Nonnodular marrow infiltration and/or lymphocyte doubling time < 12 months

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

• Polymerase chain reaction-amplifiable clonal CDR III rearrangement of the immunoglobulin variable heavy chain gene

• No Richter's syndrome or B-prolymphocytic leukemia

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• No concurrent disease resulting in major organ dysfunction

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other concurrent malignancy

• No New York Heart Association class III or IV cardiac failure

• No cardiomyopathy

• No history of myocardial infarction

• No symptomatic coronary heart disease

• No severe cardiac arrhythmia

• No severe or uncontrolled hypertension

• No chronic pulmonary disease

• No pulmonary function test impairment

• No severe or uncontrolled diabetes mellitus

• Bilirubin or transaminases ≤ 1.5 times upper limit of normal

• Creatinine ≤ 1.4 mg/dL

• No cerebral dysfunction

• No severe psychiatric impairment

• No drug addiction or alcoholism

• Negative HIV

• Negative Hepatitis B or C

• No allergy to any of the protocol drugs

• No history of anaphylactic reaction to monoclonal antibodies

• No active infection

PRIOR CONCURRENT THERAPY:

• No more than 1 prior chemotherapy regimen OR chemotherapy that lasted > 6 months

• No prior radiotherapy

• No prior treatment with alemtuzumab

• No prior long-term (> 1 month) systemic corticosteroids

• No prior therapy with dexamethasone, carmustine, etoposide, cytarabine, and melphalan (Dexa-BEAM)