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Evaluation of Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) +/- Lumiliximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT00801060
Recruitment Status : Terminated
First Posted : December 3, 2008
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE December 2, 2008
First Posted Date  ICMJE December 3, 2008
Last Update Posted Date October 2, 2015
Study Start Date  ICMJE February 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2009)
  • To evaluate the safety and tolerability of FCR+L compared with FCR alone in subjects with previously untreated CLL. [ Time Frame: June 2010 ]
  • To evaluate the efficacy of FCR+L compared with FCR alone in subjects with previously untreated CLL. [ Time Frame: June 2010 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
  • To evaluate whether FCR+L versus FCR affects ECG results, with focus on the QTcF interval in subjects with previously untreated CLL. [ Time Frame: February 2010 ]
  • To evaluate the effect of lumiliximab on the pharmacokinetics of fludarabine, cyclophosphamide, and rituximab in subjects with previously untreated CLL. [ Time Frame: February 2010 ]
Change History Complete list of historical versions of study NCT00801060 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
  • To evaluate the safety and tolerability of FCR+L compared with FCR alone in subjects with previously untreated CLL. [ Time Frame: February 2010 ]
  • To evaluate the efficacy of FCR+L compared with FCR alone in subjects with previously untreated CLL. [ Time Frame: February 2010 ]
  • To determine the pharmacokinetics of lumiliximab when given in combination with FCR in subjects with previously untreated CLL. [ Time Frame: February 2010 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) +/- Lumiliximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphocytic Leukemia
Intervention  ICMJE
  • Drug: Lumiliximab + FCR
    Dose, schedule, and duration in the protocol
  • Drug: FCR
    Dosage, schedule, and duration in the protocol
Study Arms  ICMJE
  • 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

    Intervention: Drug: Lumiliximab + FCR
  • 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

    Intervention: Drug: FCR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 8, 2009)
40
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2008)
60
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   France,   Poland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00801060
Other Study ID Numbers  ICMJE 152CL202
EUDRACT NO: 2008-002204-25
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP