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

September 17, 2015 updated by: Biogen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

See protocol.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Research Site
    • Victoria
      • Melbourne (Coburg), Victoria, Australia, 3058
        • Research Site
  • Austria
      • Graz, Austria, 8036
        • Research Site
      • Wien, Austria, 1090
        • Research Site
      • Wien, Austria, 1190
        • Research Site
  • Belgium
      • Antwerpen, Belgium, 2060
        • Research Site
      • Brussels, Belgium, 1000
        • Research Site
      • Brussels, Belgium, 1200
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Mont-Godinne, Belgium, 5530
        • Research Site
      • Roeselare, Belgium, 8800
        • Research Site
      • Wilrijk, Belgium, 2610
        • Research Site
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H1A2
        • Research Site
  • France
      • Lille, France, 59000
        • Research Site
      • Montpellier, France, 34295
        • Research Site
      • Pessac, France, 33604
        • Research Site
      • Strasbourg, France, 67000
        • Research Site
      • Tours, France, 37044
        • Research Site
    • Cedex
      • Paris, Cedex, France, 75475
        • Research Site
      • Pierre Benite, Cedex, France, 69495
        • Research Site
  • Poland
      • Bialystok, Poland, 15-276
        • Research Site
      • Gdansk, Poland, 80-952
        • Research Site
      • Lodz, Poland, 93-510
        • Research Site
  • United Kingdom
      • Bath, Avon, United Kingdom, BA13NG
        • Research Site
    • Devon
      • Exeter, Devon, United Kingdom, EX25DW
        • Research Site
      • Plymouth, Devon, United Kingdom, PL68DH
        • Research Site
    • England
      • London, England, United Kingdom, WC1E6DB
        • Research Site
  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida/Pulmonary, Critical Care & Sleep Medicine
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 7601
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center-IPF Program
    • Washington
      • Seattle, Washington, United States, 98101
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Lumiliximab + FCR
Dose, schedule, and duration in the protocol
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
Drug: FCR
Dosage, schedule, and duration in the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety and tolerability of FCR+L compared with FCR alone in subjects with previously untreated CLL.
Time Frame: June 2010
June 2010
To evaluate the efficacy of FCR+L compared with FCR alone in subjects with previously untreated CLL.
Time Frame: June 2010
June 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

December 2, 2008

First Submitted That Met QC Criteria

December 2, 2008

First Posted (Estimate)

December 3, 2008

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 152CL202
  • EUDRACT NO: 2008-002204-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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