Evaluation of Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) +/- Lumiliximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT00801060
Last Updated: 2015-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
40 participants
INTERVENTIONAL
2008-02-29
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Group A
FCR + 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
Lumiliximab + FCR
Dose, schedule, and duration in the protocol
Treatment Group B
FCR
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
FCR
Dosage, schedule, and duration in the protocol
Interventions
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Lumiliximab + FCR
Dose, schedule, and duration in the protocol
FCR
Dosage, schedule, and duration in the protocol
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
* Active bacterial, viral, or fungal infections.
* Any known family history of long QT syndrome.
* Seizure disorders requiring anticonvulsant therapy.
* Severe chronic obstructive pulmonary disease with hypoxemia.
* Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1.
* Clinically active autoimmune disease.
* Presence of history of Coombs positive hemolytic anemia.
* Pregnant or currently breastfeeding at Screening.
* Prior exposure to lumiliximab or any other anti CD23 antibody.
* Subjects with known hypersensitivity to Chinese hamster ovary cell proteins, murine proteins, or any component of fludarabine, cyclophosphamide, rituximab, or the lumiliximab investigational treatment.
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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University of Florida/Pulmonary, Critical Care & Sleep Medicine
Gainesville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Research Site
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Research Site
Detroit, Michigan, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Research Site
Hackensack, New Jersey, United States
Vanderbilt University Medical Center-IPF Program
Nashville, Tennessee, United States
Research Site
Seattle, Washington, United States
Research Site
Westmead, New South Wales, Australia
Research Site
Melbourne (Coburg), Victoria, Australia
Research Site
Graz, , Austria
Research Site
Vienna, , Austria
Research Site
Vienna, , Austria
Research Site
Antwerp, , Belgium
Research Site
Brussels, , Belgium
Research Site
Brussels, , Belgium
Research Site
Leuven, , Belgium
Research Site
Mont-Godinne, , Belgium
Research Site
Roeselare, , Belgium
Research Site
Wilrijk, , Belgium
Research Site
Ottawa, Ontario, Canada
Research Site
Paris, Cedex, France
Research Site
Pierre-Bénite, Cedex, France
Research Site
Lille, , France
Research Site
Montpellier, , France
Research Site
Pessac, , France
Research Site
Strasbourg, , France
Research Site
Tours, , France
Research Site
Bialystok, , Poland
Research Site
Gdansk, , Poland
Research Site
Lodz, , Poland
Research Site
Exeter, Devon, United Kingdom
Research Site
Plymouth, Devon, United Kingdom
Research Site
London, England, United Kingdom
Research Site
Bath, Avon, , United Kingdom
Countries
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Other Identifiers
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EUDRACT NO: 2008-002204-25
Identifier Type: -
Identifier Source: secondary_id
152CL202
Identifier Type: -
Identifier Source: org_study_id
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