Lumiliximab With Fludarabine, Cyclophosphamide, and Rituximab (FCR) Versus FCR Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)
LUCID
A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia
1 other identifier
interventional
627
22 countries
172
Brief Summary
This is a randomized (1:1), open-label, multicenter, active-controlled study in patients with previously treated CD23+ and CD20+ relapsed CLL. Patients will receive treatment with either lumiliximab in combination with FCR or FCR alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2006
Typical duration for phase_2
172 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2006
CompletedFirst Posted
Study publicly available on registry
October 23, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedOctober 2, 2015
April 1, 2011
3.7 years
October 19, 2006
September 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Response (CR) rate
Every 3 months until all patients have reached at least week 33
Secondary Outcomes (2)
Time to event variables (progression free survival, duration of response, time to next therapy, time to progression and overall survival)
Every 3 months until all patients have reached at least week 33
Response variables
Every 3 months until all patients have reached at least week 33
Study Arms (2)
1
ACTIVE COMPARATORFCR 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
2
EXPERIMENTALFCR + 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
Interventions
Eligibility Criteria
You may qualify if:
- Signed, written EC-approved informed consent form.
- Diagnosis of relapsed CD23+ and CD20+ B cell CLL as defined by NCI WG guidelines.
- Subjects who have received at least 1 but no more than 2 prior single agent or combination treatments for CLL.
- Rai Stage III or IV (Binet Stage C), or Rai Stage I or II (Binet Stage A or B) if determined to have disease progression as evidenced by rapid doubling of peripheral lymphocyte count, progressive lymphadenopathy, progressive splenomegaly, or B symptoms (Staging Criteria - Modified Rai).
- WHO Performance Status less than or equal to 2.
- Age greater than or equal to 18 years.
- Male and female subjects of reproductive potential must agree to follow accepted birth control methods during treatment and for 12 months after completion of treatment.
- Acceptable liver function: bilirubin less than or equal to 2.0 mg/dL (26 µmol/L); AST and ALT less than or equal to 2 times upper limit of normal.
- Acceptable hematologic status: platelet count greater than or equal to 50 x 10\^9/L should be unsupported by transfusion; ANC greater than or equal to 1 x 10\^9/L.
- Acceptable renal function: creatinine clearance calculated according to the formula of Cockcroft and Gault \>50 mL/min; serum creatinine less than or equal to 1.5 times upper limit of normal.
You may not qualify if:
- Subjects who are refractory to the following combination therapies: purine analogue + R, purine analogue + C, or purine analogue + CR. Refractory is defined as not achieving at least a PR for a minimum duration of 6 months as determined by treating physician. Purine analogues include fludarabine, pentostatin and cladribine.
- Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or other investigational therapy within 4 weeks prior to Study Day 1.
- Previous exposure to lumiliximab or other anti-CD23 antibodies.
- Prior autologous or allogeneic BMT or hematopoetic stem cell transplant.
- Known infection with HIV, hepatitis B, or hepatitis C. Although testing for hepatitis B or hepatitis C is not mandatory, this should be considered for all subjects considered at high risk of hepatitis B or hepatitis C infection and in endemic areas. Subjects with any serological evidence of current or past hepatitis B or hepatitis C exposure are excluded unless the serological findings are clearly due to vaccination.
- Uncontrolled diabetes mellitus.
- Uncontrolled hypertension.
- Transformation to aggressive B-cell malignancy (e.g., large B cell lymphoma, Richter's Syndrome, or PLL).
- Secondary malignancy requiring active treatment (except hormonal therapy).
- Any medical condition that would require long-term use (\>1 month) of systemic corticosteroids during study treatment. However, steroid use less than or equal to 1 month is permissible during the study.
- Any serious nonmalignant disease or laboratory abnormality, which in the opinion of the Investigator and/or Sponsor would compromise protocol objectives.
- Active uncontrolled bacterial, viral, or fungal infections.
- New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Study Day 1, unstable arrhythmia, or evidence of ischemia on ECG within 30 days prior to Study Day 1.
- Seizure disorders requiring anticonvulsant therapy.
- Severe chronic obstructive pulmonary disease with hypoxemia.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (194)
Research Site
Scottsdale, Arizona, United States
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Alhambra, California, United States
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Burbank, California, United States
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Fullerton, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Oxnard, California, United States
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Pomona, California, United States
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Redondo Beach, California, United States
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Sacramento, California, United States
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Santa Maria, California, United States
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Fort Myers, Florida, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Maywood, Illinois, United States
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Indianapolis, Indiana, United States
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Overland Park, Kansas, United States
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Shreveport, Louisiana, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Saint Joseph, Michigan, United States
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Ypsilant,, Michigan, United States
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Minneapolis, Minnesota, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Omaha, Nebraska, United States
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Hackensack, New Jersey, United States
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Morristown, New Jersey, United States
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Chapel Hill, North Carolina, United States
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Raleigh, North Carolina, United States
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Columbus, Ohio, United States
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Kettering, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Greenville, South Carolina, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Bedford, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Fredericksburg, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Norfolk, Virginia, United States
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Roanoke, Virginia, United States
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Kennewick, Washington, United States
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Saint Louis, Washington, United States
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Spokane, Washington, United States
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Yakima, Washington, United States
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Córdoba, Argentina
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Mendoza, Argentina
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Darlinghurst, New South Wales, Australia
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Gosford, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Waratah, New South Wales, Australia
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Westmead, New South Wales, Australia
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Greenslopes, Queensland, 4120, Australia
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Herston, Queensland, Australia
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South Brisbane, Queensland, Australia
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Woolloongabba, Queensland, Australia
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Adelaide, South Australia, 5000, Australia
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Adelaide, South Australia, Australia
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Ashford, South Australia, Australia
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Woodville, South Australia, Australia
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Box Hill, Victoria, 3128, Australia
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Clayton, Victoria, 3168, Australia
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Clayton, Victoria, Australia
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East Melbourne, Victoria, Australia
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Fitzroy, Victoria, 3065, Australia
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Freemantle, Western Australia, Australia
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Nedlands, Western Australia, Australia
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Perth, Western Australia, Australia
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Melbourne, Australia
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Graz, Austria
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Innsbruck, Austria
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Salzburg, Austria
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Vienna, Austria
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Antwerp, Belgium
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Bruges, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Ghent, Belgium
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Herestraat, Belgium
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Yvoir, Belgium
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Goiania - GO, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Santo André, Brazil
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São Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Hamilton, Canada
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Québec, Canada
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Brno, Czechia
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Hradec Králové, Czechia
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Prague, Czechia
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Angers, France
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Bordeaux, France
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Le Mans, France
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Lille, France
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Limoges, France
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Nantes, France
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Nice, France
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Pessac, France
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Rennes, France
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Rouen, France
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Tours, France
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Augsburg, Germany
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Dessau, Germany
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Frankfurt, Germany
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Greifswald, Germany
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Kiel, Germany
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Würzburg, Germany
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Athens, Greece
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Heraklion, Greece
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Ahmedabad, India
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Bangalore, India
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Delhi, India
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Mumbai, India
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Nashik, India
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New Delhi, India
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Pune, India
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Trivandrum, India
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Ashkelon, Israel
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Haifa, Israel
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Jerusalem, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Rehovo, Israel
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Milan, Italy
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Novara, Italy
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Roma, Italy
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Rome, Italy
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Rozzano, Italy
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Verona, Italy
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Klaipėda, Lithuania
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Auckland, New Zealand
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Christchurch, New Zealand
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Hamilton, New Zealand
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Palmerston North, New Zealand
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Wellington, New Zealand
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Bialystok, Poland
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Gdansk, Poland
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Szczecin, Poland
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Warsaw, Poland
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Almada, Portugal
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Braga, Portugal
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Coimbra, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Viseu, Portugal
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Brasov, Romania
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Bucharest, Romania
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Iași, Romania
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Nizhny Novgorod, Russia
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Obninsk, Russia
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Ryazan, Russia
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Saint Peterburg, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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Yekaterinburg, Russia
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Banská Bystrica, Slovakia
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Bratislava, Slovakia
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Martin, Slovakia
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Madrid, Spain
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Murcia, Spain
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Palma de Mallorca, Spain
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Salamanca, Spain
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Toledo, Spain
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Zaragoza, Spain
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Bath, United Kingdom
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Belfast, United Kingdom
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Birmingham, United Kingdom
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Bournemouth, United Kingdom
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Edinburgh, United Kingdom
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Glasgow, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Plymouth, United Kingdom
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Surrey, United Kingdom
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Taunton, United Kingdom
Related Publications (4)
Byrd JC, Kipps TJ, Flinn IW, Castro J, Lin TS, Wierda W, Heerema N, Woodworth J, Hughes S, Tangri S, Harris S, Wynne D, Molina A, Leigh B, O'Brien S. Phase 1/2 study of lumiliximab combined with fludarabine, cyclophosphamide, and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia. Blood. 2010 Jan 21;115(3):489-95. doi: 10.1182/blood-2009-08-237727. Epub 2009 Oct 20.
PMID: 19843887BACKGROUNDPathan NI, Chu P, Hariharan K, Cheney C, Molina A, Byrd J. Mediation of apoptosis by and antitumor activity of lumiliximab in chronic lymphocytic leukemia cells and CD23+ lymphoma cell lines. Blood. 2008 Feb 1;111(3):1594-602. doi: 10.1182/blood-2007-03-082024. Epub 2007 Nov 21.
PMID: 18032710BACKGROUNDByrd JC, O'Brien S, Flinn IW, Kipps TJ, Weiss M, Rai K, Lin TS, Woodworth J, Wynne D, Reid J, Molina A, Leigh B, Harris S. Phase 1 study of lumiliximab with detailed pharmacokinetic and pharmacodynamic measurements in patients with relapsed or refractory chronic lymphocytic leukemia. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4448-55. doi: 10.1158/1078-0432.CCR-06-1463.
PMID: 17671129BACKGROUNDAwan FT, Hillmen P, Hellmann A, Robak T, Hughes SG, Trone D, Shannon M, Flinn IW, Byrd JC; LUCID trial investigators. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia. Br J Haematol. 2014 Nov;167(4):466-77. doi: 10.1111/bjh.13061. Epub 2014 Aug 8.
PMID: 25130401DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2006
First Posted
October 23, 2006
Study Start
November 1, 2006
Primary Completion
July 1, 2010
Study Completion
December 1, 2010
Last Updated
October 2, 2015
Record last verified: 2011-04