Status:
COMPLETED
FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Biogen
Genentech, Inc.
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 31 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2012
Estimated Enrollment :
552 Patients enrolled
Trial Details
Trial ID
NCT00090051
Start Date
July 31 2003
End Date
May 31 2012
Last Update
August 1 2017
Active Locations (106)
Enter a location and click search to find clinical trials sorted by distance.
1
Uab Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
2
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, United States, 92708
3
California Cancer Center Woodward Park; Community Medical Centers
Fresno, California, United States, 93720
4
Rush-Presbyterian St. Luke'S Medical Center
Chicago, Illinois, United States, 60612