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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00801060




Registration number
NCT00801060
Ethics application status
Date submitted
2/12/2008
Date registered
3/12/2008
Date last updated
2/10/2015

Titles & IDs
Public title
Evaluation of Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) +/- Lumiliximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Scientific 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
Secondary ID [1] 0 0
EUDRACT NO: 2008-002204-25
Secondary ID [2] 0 0
152CL202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lumiliximab + FCR
Treatment: Drugs - FCR

Experimental: 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

Active comparator: 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


Treatment: Drugs: Lumiliximab + FCR
Dose, schedule, and duration in the protocol

Treatment: Drugs: FCR
Dosage, schedule, and duration in the protocol
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability of FCR+L compared with FCR alone in subjects with previously untreated CLL.
Timepoint [1] 0 0
June 2010
Primary outcome [2] 0 0
To evaluate the efficacy of FCR+L compared with FCR alone in subjects with previously untreated CLL.
Timepoint [2] 0 0
June 2010

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2010
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Research Site - Westmead
Recruitment hospital [2] 0 0
Research Site - Melbourne (Coburg)
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3058 - Melbourne (Coburg)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New Hampshire
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Austria
State/province [8] 0 0
Graz
Country [9] 0 0
Austria
State/province [9] 0 0
Wien
Country [10] 0 0
Belgium
State/province [10] 0 0
Antwerpen
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussels
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Belgium
State/province [13] 0 0
Mont-Godinne
Country [14] 0 0
Belgium
State/province [14] 0 0
Roeselare
Country [15] 0 0
Belgium
State/province [15] 0 0
Wilrijk
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
France
State/province [17] 0 0
Cedex
Country [18] 0 0
France
State/province [18] 0 0
Lille
Country [19] 0 0
France
State/province [19] 0 0
Montpellier
Country [20] 0 0
France
State/province [20] 0 0
Pessac
Country [21] 0 0
France
State/province [21] 0 0
Strasbourg
Country [22] 0 0
France
State/province [22] 0 0
Tours
Country [23] 0 0
Poland
State/province [23] 0 0
Bialystok
Country [24] 0 0
Poland
State/province [24] 0 0
Gdansk
Country [25] 0 0
Poland
State/province [25] 0 0
Lodz
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Devon
Country [27] 0 0
United Kingdom
State/province [27] 0 0
England
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Bath, Avon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00801060
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00801060