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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

Phase 3
18 Years
Not Enrolling
Chronic Lymphocytic Leukemia

Thank you

Trial Information

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)

Outcome Description:

Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.

Outcome Time Frame:

Mean observation time at time of analysis was approximately 26 months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2003

Completion Date:

May 2012

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Research Site Asheville, North Carolina