Lumiliximab With Fludarabine, Cyclophosphamide, and Rituximab (FCR) Versus FCR Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL) (LUCID)
September 17, 2015 updated by: Biogen
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
627
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
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Cordoba, Argentina
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Mendoza, Argentina
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Melbourne, Australia
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New South Wales
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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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Queensland
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Greenslopes, Queensland, Australia, 4120
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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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South Australia
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Adelaide, South Australia, Australia, 5000
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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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Victoria
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Box Hill, Victoria, Australia, 3128
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Clayton, Victoria, Australia, 3168
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Clayton, Victoria, Australia
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East Melbourne, Victoria, Australia
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Fitzroy, Victoria, Australia, 3065
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Western 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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Graz, Austria
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Innsbruck, Austria
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Salzburg, Austria
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Wien, Austria
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Antwerpen, Belgium
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Brugge, Belgium
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Bruxelles, 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 Andre, Brazil
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Sao Paulo, Brazil
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Hamilton, Canada
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Quebec City, Canada
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Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Nova Scotia
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Halifax, Nova Scotia, Canada
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Ontario
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Brno, Czech Republic
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Hradec Kralove, Czech Republic
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Prague, Czech Republic
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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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Wurzburg, Germany
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Athens, Greece
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Herakleion, 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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Petach Tikva, Israel
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Ramat Gan, Israel
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Rehovo, Israel
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Milano, 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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Klaipeda, 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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Warszawa, 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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Iasi, Romania
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Ekaterinburg, Russian Federation
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Nizhniy Novgorod, Russian Federation
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Obninsk, Russian Federation
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Ryazan, Russian Federation
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Samara, Russian Federation
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Saratov, Russian Federation
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St. Peterburg, Russian Federation
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St. Petersburg, Russian Federation
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Banska 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
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Arizona
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Scottsdale, Arizona, United States
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California
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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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Florida
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Fort Myers, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Illinois
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Chicago, Illinois, United States
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Maywood, Illinois, United States
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Indiana
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Indianapolis, Indiana, United States
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Kansas
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Overland Park, Kansas, United States
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Louisiana
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Shreveport, Louisiana, United States
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Massachusetts
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Boston, Massachusetts, United States
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Michigan
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Detroit, Michigan, United States
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St. Joseph, Michigan, United States
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Ypsilant,, Michigan, United States
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Minnesota
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Minneapolis, Minnesota, United States
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Missouri
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Columbia, Missouri, United States
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St. Louis, Missouri, United States
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Montana
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Billings, Montana, United States
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Nebraska
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Omaha, Nebraska, United States
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New Jersey
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Hackensack, New Jersey, United States
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Morristown, New Jersey, United States
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North Carolina
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Chapel Hill, North Carolina, United States
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Raleigh, North Carolina, United States
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Ohio
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Columbus, Ohio, United States
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Kettering, Ohio, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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South Carolina
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Greenville, South Carolina, United States
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Tennessee
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Nashville, Tennessee, United States
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Texas
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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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Virginia
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Norfolk, Virginia, United States
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Roanoke, Virginia, United States
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Washington
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Kennewick, Washington, United States
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Spokane, Washington, United States
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St. Louis, Washington, United States
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Yakima, Washington, United States
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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:
- 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.
Exclusion Criteria:
- 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.
- Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1.
- Clinically active autoimmune disease.
- History of fludarabine-induced autoimmune cytopenia (as judged by the Investigator) or Coombs-positive haemolytic anemia.
- Pregnant or currently breastfeeding.
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 |
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Active Comparator: 1
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 |
Dose, schedule, and duration specified in protocol
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Experimental: 2
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 |
Dose, schedule, and duration specified in the protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Complete Response (CR) rate
Time Frame: Every 3 months until all patients have reached at least week 33
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Every 3 months until all patients have reached at least week 33
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Time to event variables (progression free survival, duration of response, time to next therapy, time to progression and overall survival)
Time Frame: Every 3 months until all patients have reached at least week 33
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Every 3 months until all patients have reached at least week 33
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Response variables
Time Frame: Every 3 months until all patients have reached at least week 33
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Every 3 months until all patients have reached at least week 33
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Pathan 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.
- Byrd 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.
- Awan 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.
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
November 1, 2006
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
October 19, 2006
First Submitted That Met QC Criteria
October 19, 2006
First Posted (Estimate)
October 23, 2006
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
- 152CL201
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.