CLL-Irl Study. CTRIAL-IE (ICORG) 07-01, V7

• Status: Completed
• Trial end date: 2019-11-21
• 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 rituximab, 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. Giving fludarabine together with cyclophosphamide and rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works in treating patients with chronic lymphocytic leukemia.

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

Details

• Lead Sponsor: Cancer Trials Ireland
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of chronic lymphocytic leukemia

• Stage I-IV disease (Binet stage progressive A, B, C)

• CD5 and CD23 positive

• Untreated OR relapsed/resistant disease after combination chemotherapy or rituximab

• No 17p deletion

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• Life expectancy > 1 year

• Creatinine clearance ≥ 50 mL/min

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other concurrent malignancy except for noninvasive cervical cancer or localized nonmelanomatous skin cancer

• No history of anaphylaxis to mouse-derived humanized monoclonal antibody

• No other severe concurrent (e.g., cardiac or pulmonary) diseases or mental disorders that could interfere with ability to participate in the study

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics