Fludarabine, Cyclophosphamide, and Rituximab or Alemtuzumab in Treating CLL2007 CLL 2007 FMP

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to kill cancer cells or stop them from growing. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. It is not yet known whether giving fludarabine and cyclophosphamide together with rituximab is more effective than giving fludarabine and cyclophosphamide together with alemtuzumab in treating B-cell chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works as first-line therapy compared with giving fludarabine together with cyclophosphamide and alemtuzumab in treating patients with B-cell chronic lymphocytic leukemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French Innovative Leukemia Organisation
• Treatments: Alemtuzumab; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

Inclusion

Diagnosis of B-cell chronic lymphocytic leukemia (CLL), meeting the following criteria:

• Binet classification stages B or C

• Del 17 p (FISH) negative (< 10 % positives cores)

• Matutes score 4 or 5

Exclusion Transformation to aggressive B-cell malignancy (e.g. diffuse large cell lymphoma, Hodgkin lymphoma, or prolymphocytic leukemia)

PATIENT CHARACTERISTICS:

Exclusion ECOG performance status ≥ 2

• Life expectancy < 6 months

• Creatinine clearance < 60 mL/min

• Total bilirubin > 2 x upper limit of normal (ULN)

• Gamma glutamyltransferase or transaminase levels > 2 x ULN

• Cumulative illness rating scale > 6

• HIV seropositivity

• Hepatitis B or C seropositivity (unless clearly due to vaccination)

• Clinically significant autoimmune anemia

• Active bacterial, viral, or fungal infection

• Active second malignancy currently requiring treatment (except basal cell carcinoma or in situ endometrial carcinoma) and/or less than 5 years complete remission after breast cancer

• Any severe comorbid conditions including, but not limited to, any of the following:

• Class III or IV heart failure

• Recent myocardial infarction

• Unstable angina

• Ventricular tachyarrhythmias requiring ongoing treatment

• Severe chronic obstructive pulmonary disease with hypoxemia

• Uncontrolled diabetes mellitus

• Uncontrolled hypertension

• Concomitant disease requiring prolonged use of corticosteroids (> 1 month)

• Known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs

• Contraindication to the use of rituximab or alemtuzumab according to Summary of Product Characteristics

• Any coexisting medical or psychological condition that would preclude participation in the required study procedures

• Any mental deficiency preventing proper understanding of the requirements of treatment

• Person under law control

• Pregnant or breastfeeding women

• Fertile patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study

PRIOR CONCURRENT THERAPY:

Inclusion

• No prior chemotherapy, radiotherapy, or immunotherapy for CLL

• Corticosteroids within the past month allowed