FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	August 23, 2004
Last Updated Date	September 4, 2007
Start Date ^†	June 2003
Current Primary Outcome Measures ^† (submitted: September 13, 2005)	Progression-free survival
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00090051 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: September 5, 2007)	Event-free survival Disease-free survival in CR patients Duration of response Complete response rate Nodular partial response rate Partial response rate Overall survival Safety profile Quality of life
Original Secondary Outcome Measures ^† (submitted: September 13, 2005)	Event-free survival Disease-free survival in CR patients Duration of response Complete response rate Nodular partial response rate Partial response rate Overall survival Safety profile Quality of life

Descriptive Information
Brief Title ^†	FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL)
Official Title ^†	Open-Label, Multicenter, Randomized, Comparative, Phase III Study to Evaluate the Efficacy and Safety of FCR vs. FC Alone in Previously Treated Patients With CD20 Positive B-Cell CLL
Brief Summary	The purpose of this study is to provide treatment for patients who have CLL, and to compare the use of rituximab added to FC with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.
Detailed Description
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^†	Chronic Lymphocytic Leukemia
Intervention ^†	Drug: Rituxan®
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Estimated Enrollment ^†	550
Completion Date
Primary Completion Date
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 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 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States, Australia, Belgium, Canada, Denmark, France, Hungary, Italy, Netherlands, New Zealand, Norway, Poland, Romania, Russian Federation, Spain, Sweden, United Kingdom
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00090051
Responsible Party
Secondary IDs ^††
Study Sponsor ^†	Biogen Idec
Collaborators ^††	Hoffmann-La Roche Genentech
Investigators ^†
Information Provided By	Biogen Idec
Verification Date	September 2007
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.