Chronic Lymphocytic LeukemiaPhase 2NCT00801060
Evaluation of Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) +/- Lumiliximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study testing Lumiliximab + FCR and FCR in people with Chronic Lymphocytic Leukemia, run by Biogen at 36 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Lumiliximab + FCR and FCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 36 sitesin 8 countries
- Study dates
- Feb 2008to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
36 sites in 8 countries.
36 sites in 8 countries
United States9 sites
Research Site
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
Research Site
Detroit, Michigan, 48202
University of Florida/Pulmonary, Critical Care & Sleep Medicine
Gainesville, Florida, 32610
Research Site
Hackensack, New Jersey, 7601
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Miami Miller School of Medicine
Miami, Florida, 33136
Vanderbilt University Medical Center-IPF Program
Nashville, Tennessee, 37232
Research Site
Seattle, Washington, 98101
Belgium7 sites
Research Site
Antwerp, 2060
Research Site
Brussels, 1000
Research Site
Brussels, 1200
Research Site
Leuven, 3000
Research Site
Mont-Godinne, 5530
Research Site
Roeselare, 8800
Research Site
Wilrijk, 2610
France7 sites
Research Site
Lille, 59000
Research Site
Montpellier, 34295
Research Site
Paris, Cedex, 75475
Research Site
Pessac, 33604
Research Site
Pierre-Bénite, Cedex, 69495
Research Site
Strasbourg, 67000
Research Site
Tours, 37044
United Kingdom4 sites
Research Site
Bath, Avon, BA13NG
Research Site
Exeter, Devon, EX25DW
Research Site
London, England, WC1E6DB
Research Site
Plymouth, Devon, PL68DH
Austria3 sites
Research Site
Graz, 8036
Research Site
Vienna, 1090
Research Site
Vienna, 1190
Poland3 sites
Research Site
Bialystok, 15-276
Research Site
Gdansk, 80-952
Research Site
Lodz, 93-510
Australia2 sites
Research Site
Melbourne (Coburg), Victoria, 3058
Research Site
Westmead, New South Wales, 2145
About this study
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
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.
Read the detailed description
See protocol.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Lumiliximab + FCR, FCR
- Keywords
- Fludara, CD23, Cyclophosphamide, Antibody, Fludarabine, CLL, Rituximab, Mabthera, Biogen Idec, Lumiliximab, Rituxan, Cytoxan, Chronic Lymphocytic Leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumiliximab + FCRDrug
Dose, schedule, and duration in the protocol
FCRDrug
Dosage, schedule, and duration in the protocol
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Experimental | 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 Receives: Drug: Lumiliximab + FCR |
| Treatment Group B | Active comparator | 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 Receives: Drug: FCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of FCR+L compared with FCR alone in subjects with previously untreated CLL.
Measured: June 2010
To evaluate the efficacy of FCR+L compared with FCR alone in subjects with previously untreated CLL.
Measured: June 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801060
- Sponsor's protocol ID
- 152CL202
- Other IDs
- EUDRACT NO: 2008-002204-25
- Status last verified
- Apr 2011
- First submitted
- 2 Dec 2008
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00801060
- Acronym / sponsor ID
- 152CL202
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Fludara, CD23, Cyclophosphamide, Antibody, Fludarabine, CLL, Rituximab, Mabthera
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 3 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Experimental | Drug: Lumiliximab + FCRFCR + 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 |
| Treatment Group B | Active comparator | Drug: FCRFCR 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumiliximab + FCRDose, schedule, and duration in the protocol | Drug | Treatment Group A |
| FCRDosage, schedule, and duration in the protocol | Drug | Treatment Group B |
Primary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
36 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lumiliximab + FCR and FCR in people with Chronic Lymphocytic Leukemia, run by Biogen at 36 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Belgium, France, United Kingdom, Austria and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of FCR+L compared with FCR alone in subjects with previously untreated CLL. (time frame: June 2010). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015.