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FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL)
This study has been completed.
Sponsors and Collaborators: Biogen Idec
Hoffmann-La Roche
Genentech
Information provided by: Biogen Idec
ClinicalTrials.gov Identifier: NCT00090051
  Purpose

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.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Rituxan®
Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Rituximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Progression-free survival

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 550
Study Start Date: June 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090051

  Show 87 Study Locations
Sponsors and Collaborators
Biogen Idec
Hoffmann-La Roche
Genentech
  More Information

Study ID Numbers: 102-14
Study First Received: August 23, 2004
Last Updated: September 4, 2007
ClinicalTrials.gov Identifier: NCT00090051  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Rituximab
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, chronic
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009