Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. A peripheral stem cell transplant using stem cells from the patient or a donor may replace the patient's immune cells that were destroyed by chemotherapy.

PURPOSE: This phase II trial is studying how well giving fludarabine together with alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplant or alemtuzumab works in treating patients with advanced or progressive chronic lymphocytic leukemia.

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

Details

• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Treatments: Alemtuzumab; Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of chronic lymphocytic leukemia (CLL)

• Advanced or progressive disease with ≥ 2 active clinical signs

PATIENT CHARACTERISTICS:

• Fertile patients must use adequate contraception

• No positive Coomb's test with signs of hemolysis

• No active infection

• No uncontrolled severe disease

• No known hypersensitivity or anaphylactic reactions to murine antibodies or proteins

• No other malignancies within the past 2 years except for adequately treated malignancies

• No significant traumatic injury within the past 4 weeks

• No coexisting medical or psychological condition that would limit study compliance

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior treatment for CLL

• No major surgery within the past 4 weeks

• No prior chemotherapy