FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients

Completed · Phase 3

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT00090051

Run by

Hoffmann-La Roche

People needed

552

Starts

2003-07-31

Expected to finish

2012-05-31

Last updated by the study team

2017-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pacific Coast Hematology/Oncology Medical Group — Fountain Valley, California, United States
• California Cancer Center Woodward Park; Community Medical Centers — Fresno, California, United States
• Rush-Presbyterian St. Luke'S Medical Center — Chicago, Illinois, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Milton S. Hershey Medical Center; Penn State Cancer Inst. — Hershey, Pennsylvania, United States
• Concord Repatriation General Hospital; Haematology — Sydney, New South Wales, Australia
• Mater Hospital; Division of Cancer Services — Brisbane, Queensland, Australia
• Frankston Hospital; Oncology/Haematology — Frankston, Victoria, Australia
• Peter Maccallum Cancer Institute; Medical Oncology — Melbourne, Victoria, Australia
• ZNA Stuivenberg — Antwerp, Belgium
• Institut Jules Bordet — Brussels, Belgium
• UZ Leuven Gasthuisberg — Leuven, Belgium
• Uni of Alberta Hospital — Edmonton, Alberta, Canada
• BCCA-Vancouver Cancer Centre — Vancouver, British Columbia, Canada
• Health Science Centre — St. John's, Newfoundland and Labrador, Canada
• QEII HSC; Oncology — Halifax, Nova Scotia, Canada
• Hamilton Health Sciences - Juravinski Cancer Centre; Hematology — Hamilton, Ontario, Canada
• The Ottawa Regional Hospital - General Campus; Division of Hematology, Box 704 — Ottawa, Ontario, Canada
• Sunnybrook Odette Cancer Centre — Toronto, Ontario, Canada
• University Health Network; Princess Margaret Hospital; Medical Oncology Dept — Toronto, Ontario, Canada
• Mcgill University - Royal Victoria Hospital; Oncology — Montreal, Quebec, Canada
• Aarhus Universitetshospital, Hæmatologisk Afdeling R — Aarhus, Denmark
• Righospitalet, Hæmatologisk Klinik — København Ø, Denmark
• Hopital Avicenne; Hematologie Biologique — Bobigny, France
• Uab Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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