FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Rituximab; Fludarabine Phosphate; Cyclophosphamide
Intervention description: Intravenous repeating dose; Intravenous repeating dose; Intravenous repeating dose
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine; Fludarabine phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 552.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to provide treatment for patients who have chronic lymphocytic
      leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide
      (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of
      leukemia symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Established diagnosis of B-cell CLL by NCI Working Group criteria

          -  ≤1 previous line of chemotherapy

          -  Expected survival >6 months

          -  Acceptable hematologic status, liver function, renal function, and pulmonary function

          -  Negative serum pregnancy test for both pre-menopausal women and for women who are < 2
             years after the onset of menopause

          -  Written informed consent

        Exclusion Criteria:

          -  Prior treatment with interferon, rituximab or other monoclonal antibody

          -  Prior allogeneic bone marrow transplant (BMT) or autologous BMT or peripheral stem
             cell transplant (PBSCT) or patients who are considered to be candidates for allogeneic
             or autologous BMT or PSCT as assessed by their treating physician

          -  Fertile men or women of childbearing potential not using adequate contraception

          -  Severe Grade 3 or 4 non-hematological toxicity or prolonged (> 2 weeks) Grade 3 or 4
             cytopenia on prior fludarabine or nucleoside analogue regimen

          -  History of fludarabine-induced or clinically significant autoimmune cytopenia

          -  History of other malignancies within 2 years prior to study entry, except for
             adequately treated carcinoma in situ of the cervix; basal or squamous cell skin
             cancer; low-grade early stage localized prostate cancer treated surgically with
             curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated
             with lumpectomy alone with curative intent.

          -  Medical conditions requiring long term use (> 1 month) of systemic corticosteroids

          -  Active bacterial, viral, or fungal infection requiring systemic therapy

          -  Severe cardiac disease

          -  Seizure disorders requiring anticonvulsant therapy

          -  Severe chronic obstructive pulmonary disease with hypoxemia

          -  Uncontrolled diabetes mellitus or hypertension

          -  Transformation to aggressive B-cell malignancy.

          -  Known infection with HIV, HCV, or hepatitis B

          -  Treatment with any other investigational agent, or participation in another clinical
             trial within 30 days prior to entering this study

          -  Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins

          -  Any co-existing medical or psychological condition that would preclude participation
             in the study or compromise ability to give informed consent