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

Roche

Status and phase

Completed

Phase 3

Conditions

Chronic Lymphocytic Leukemia

Treatments

Drug: Rituximab

Drug: Cyclophosphamide

Drug: Fludarabine Phosphate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00090051

BO17072

102-14

Details and patient eligibility

About

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.

Enrollment

552 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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