Evaluation of Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) +/- Lumiliximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) in Combination With Lumiliximab Versus FCR Alone in Subjects With Previously Untreated Chronic Lymphocytic Leukemia
2 other identifiers
interventional
40
7 countries
34
Brief Summary
This is a Phase 2, randomized, open-label, multicenter study in subjects with previously untreated CLL. It is designed to evaluate safety and efficacy of fludarabine, cyclophosphamide, rituximab (FCR) and lumiliximab versus FCR alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2008
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedOctober 2, 2015
April 1, 2011
2.3 years
December 2, 2008
September 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate the safety and tolerability of FCR+L compared with FCR alone in subjects with previously untreated CLL.
June 2010
To evaluate the efficacy of FCR+L compared with FCR alone in subjects with previously untreated CLL.
June 2010
Study Arms (2)
Treatment Group A
EXPERIMENTALFCR + Lumiliximab (L) L (Lumiliximab): Day 2 50 mg/m2, Day 4 450 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks. F (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks C (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks R: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks
Treatment Group B
ACTIVE COMPARATORFCR F (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks C (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks R: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Age 18 years or older.
- Previously untreated CD23+ and CD20+ B cell CLL.
- Life expectancy \>6 months.
- Subjects with Rai Stage III or IV (Binet Stage C) or Rai Stage I or II (Binet Stage A or B) if determined to have active disease.
- World Health Organization (WHO) Performance Status ≤2.
- Normal ECG with QTc ≤450 msec for men and ≤460 msec for women. PR interval (Print) must be \<240 msec and QRS complex \<110 msec. T wave flattening and T wave inversion will be permitted.
- All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 12 months after their last dose of study treatment.
- Acceptable liver function at Screening.
- Acceptable hematologic status at Screening.
- Acceptable renal function at Screening.
- Subjects receiving any medication known to affect the QTc interval must discontinue the use of the medication or be on a stable dose of the medication for at least 3 months or 5 half-lives (whichever is longer) prior to Study Day 1, and continue (whenever possible) at the same dose throughout the study.
You may not qualify if:
- Any prior therapy for CLL.
- Known history or positive test result for human immunodeficiency virus.
- Known history of, or positive test result for Hepatitis C virus (test for Hepatitis C virus antibody) or Hepatitis B virus (test for Hepatitis B Surface Antigen and Hepatitis B Core Antibody) at Screening.
- Uncontrolled diabetes mellitus.
- Uncontrolled hypertension.
- Hypokalemia.
- Hypomagnesemia.
- New York Heart Association Class III or IV cardiac disease; myocardial infarction within the past 6 months prior to Study Day 1.
- Arrhythmia (other than sinus arrhythmia) within 30 days prior to Study Day 1.
- Evidence of active myocardial ischemia on ECG.
- Subjects with pacemakers.
- Transformation to aggressive B-cell malignancy.
- Secondary malignancy requiring active treatment.
- Any medical condition that would require long-term use (\>1 month) of systemic corticosteroids during study treatment.
- Any serious nonmalignant disease or laboratory abnormality, which would confound the evaluation of adverse events (AEs).
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (36)
University of Florida/Pulmonary, Critical Care & Sleep Medicine
Gainesville, Florida, 32610, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Research Site
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Research Site
Detroit, Michigan, 48202, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Research Site
Hackensack, New Jersey, 7601, United States
Vanderbilt University Medical Center-IPF Program
Nashville, Tennessee, 37232, United States
Research Site
Seattle, Washington, 98101, United States
Research Site
Westmead, New South Wales, 2145, Australia
Research Site
Melbourne (Coburg), Victoria, 3058, Australia
Research Site
Graz, 8036, Austria
Research Site
Vienna, 1090, Austria
Research Site
Vienna, 1190, Austria
Research Site
Antwerp, 2060, Belgium
Research Site
Brussels, 1000, Belgium
Research Site
Brussels, 1200, Belgium
Research Site
Leuven, 3000, Belgium
Research Site
Mont-Godinne, 5530, Belgium
Research Site
Roeselare, 8800, Belgium
Research Site
Wilrijk, 2610, Belgium
Research Site
Ottawa, Ontario, K1H1A2, Canada
Research Site
Paris, Cedex, 75475, France
Research Site
Pierre-Bénite, Cedex, 69495, France
Research Site
Lille, 59000, France
Research Site
Montpellier, 34295, France
Research Site
Pessac, 33604, France
Research Site
Strasbourg, 67000, France
Research Site
Tours, 37044, France
Research Site
Bialystok, 15-276, Poland
Research Site
Gdansk, 80-952, Poland
Research Site
Lodz, 93-510, Poland
Research Site
Exeter, Devon, EX25DW, United Kingdom
Research Site
Plymouth, Devon, PL68DH, United Kingdom
Research Site
London, England, WC1E6DB, United Kingdom
Research Site
Bath, Avon, BA13NG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 3, 2008
Study Start
February 1, 2008
Primary Completion
June 1, 2010
Study Completion
September 1, 2010
Last Updated
October 2, 2015
Record last verified: 2011-04