Clinical trial NCT00801060: Evaluation of Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) +/- Lumiliximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Keywords: Fludara
CD23
Cyclophosphamide
Antibody
Fludarabine
CLL
Rituximab
Mabthera
Biogen Idec
Lumiliximab
Rituxan
Cytoxan
Chronic Lymphocytic Leukemia
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2008-12-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: See protocol.

Eligibility criteria: INCLUSION CRITERIA:

* 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.

EXCLUSION CRITERIA:

* 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).
* 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.

Primary outcomes:
measure: To evaluate the safety and tolerability of FCR+L compared with FCR alone in subjects with previously untreated CLL.
timeFrame: June 2010
measure: To evaluate the efficacy of FCR+L compared with FCR alone in subjects with previously untreated CLL.
timeFrame: June 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida/Pulmonary, Critical Care & Sleep Medicine
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Hackensack
country: United States
facility: Research Site
state: New Jersey
city: Nashville
country: United States
facility: Vanderbilt University Medical Center-IPF Program
state: Tennessee
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Westmead
country: Australia
facility: Research Site
state: New South Wales
city: Melbourne (Coburg)
country: Australia
facility: Research Site
state: Victoria
city: Graz
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Antwerpen
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Mont-Godinne
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Paris
country: France
facility: Research Site
state: Cedex
city: Pierre Benite
country: France
facility: Research Site
state: Cedex
city: Lille
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Pessac
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Exeter
country: United Kingdom
facility: Research Site
state: Devon
city: Plymouth
country: United Kingdom
facility: Research Site
state: Devon
city: London
country: United Kingdom
facility: Research Site
state: England
city: Bath, Avon
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: