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| Sponsor: | Biogen Idec |
|---|---|
| Information provided by: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00391066 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia |
Drug: FCR + Lumiliximab Drug: FCR |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Open Label, Multicenter, 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 Leukemia |
| Estimated Enrollment: | 900 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: 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 |
Drug: FCR
Dose, schedule, and duration specified in protocol
|
|
2: 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 |
Drug: FCR + Lumiliximab
Dose, schedule, and duration specified in the protocol
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Biogen Idec | oncologyclinicaltrials@biogenidec.com |
Hide Study Locations| United States, Arizona | |
| Research site | Recruiting |
| Scottsdale, Arizona, United States | |
| United States, California | |
| Research Site | Recruiting |
| Alhambra, California, United States | |
| Research Site | Recruiting |
| Burbank, California, United States | |
| Research Site | Recruiting |
| Fullerton, California, United States | |
| Research Site | Terminated |
| La Jolla, California, United States | |
| Research Site | Terminated |
| Redondo Beach, California, United States | |
| Research Site | Recruiting |
| Los Angeles, California, United States | |
| Research Site | Recruiting |
| Northridge, California, United States | |
| Research Site | Terminated |
| Oxnard, California, United States | |
| Research Site | Recruiting |
| Pomona, California, United States | |
| Research Site | Recruiting |
| Long Beach, California, United States | |
| Research Site | Recruiting |
| Sacramento, California, United States | |
| Research Site | Recruiting |
| Santa Maria, California, United States | |
| United States, Florida | |
| Research Site | Recruiting |
| Fort Myers, Florida, United States | |
| United States, Georgia | |
| Research Site | Recruiting |
| Atlanta, Georgia, United States | |
| Research Site | Recruiting |
| Marietta, Georgia, United States | |
| United States, Illinois | |
| Research Site | Recruiting |
| Chicago, Illinois, United States | |
| Research Site | Recruiting |
| Maywood, Illinois, United States | |
| United States, Indiana | |
| Research Site | Recruiting |
| Beech Grove, Indiana, United States | |
| Research Site | Recruiting |
| Indianapolis, Indiana, United States | |
| United States, Kansas | |
| Research Site | Recruiting |
| Overland Park, Kansas, United States | |
| United States, Louisiana | |
| Research Site | Recruiting |
| Shreveport, Louisiana, United States | |
| United States, Massachusetts | |
| Research Site | Recruiting |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| Research Site | Recruiting |
| Detroit, Michigan, United States | |
| Research Site | Recruiting |
| Ypsilanti, Michigan, United States | |
| United States, Missouri | |
| Research Site | Recruiting |
| Billings, Missouri, United States | |
| United States, Nebraska | |
| Research Site | Recruiting |
| Omaha, Nebraska, United States | |
| United States, New Jersey | |
| Research Site | Recruiting |
| Hackensack, New Jersey, United States | |
| Research site | Recruiting |
| Morristown, New Jersey, United States | |
| United States, North Carolina | |
| Research Site | Active, not recruiting |
| Chapel Hill, North Carolina, United States | |
| Research Site | Recruiting |
| Raleigh, North Carolina, United States | |
| United States, Ohio | |
| Research Site | Recruiting |
| Columbus, Ohio, United States | |
| United States, Pennsylvania | |
| Research Site | Terminated |
| Philadelphia, Pennsylvania, United States | |
| Research Site | Recruiting |
| Pittsburgh, Pennsylvania, United States | |
| United States, South Carolina | |
| Research Site | Recruiting |
| Greenville, South Carolina, United States | |
| United States, Tennessee | |
| Research Site | Recruiting |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| Research Site | Recruiting |
| Arlington, Texas, United States | |
| Research Site | Recruiting |
| Bedford, Texas, United States | |
| Research Site | Recruiting |
| Dallas, Texas, United States | |
| Research Site | Recruiting |
| Fort Worth, Texas, United States | |
| Research Site | Recruiting |
| Fredericksburg, Texas, United States | |
| Research Site | Completed |
| Houston, Texas, United States | |
| Research Site | Recruiting |
| San Antonio, Texas, United States | |
| United States, Washington | |
| Research Site | Recruiting |
| Kennewick, Washington, United States | |
| Research Site | Recruiting |
| Spokane, Washington, United States | |
| Research Site | Recruiting |
| Yakima, Washington, United States | |
| Argentina | |
| Research Site | Recruiting |
| Buenos Aires, Argentina | |
| Research Site | Recruiting |
| Ciudad Autonoma de Buenos Aires, Argentina | |
| Research Site | Recruiting |
| Ciudad de Buenos Aires, Argentina | |
| Research Site | Recruiting |
| Cordoba, Argentina | |
| Research Site | Recruiting |
| Mendoza, Argentina | |
| Australia | |
| Research Site | Recruiting |
| Frankston, Australia | |
| Australia, New South Wales | |
| Research Site | Recruiting |
| Darlinghurst, New South Wales, Australia | |
| Research Site | Recruiting |
| Gosford, New South Wales, Australia | |
| Research Site | Recruiting |
| St. Leonards, New South Wales, Australia | |
| Research Site | Recruiting |
| Waratah, New South Wales, Australia | |
| Research Site | Recruiting |
| Westmead, New South Wales, Australia | |
| Australia, Queensland | |
| Research Site | Recruiting |
| Herston, Queensland, Australia | |
| Research Site | Recruiting |
| South Brisbane, Queensland, Australia | |
| Research Site | Recruiting |
| Woolloongabba, Queensland, Australia | |
| Australia, South Australia | |
| Research Site | Recruiting |
| Adelaide, South Australia, Australia | |
| Research Site | Recruiting |
| Ashford, South Australia, Australia | |
| Research Site | Recruiting |
| Woodville, South Australia, Australia | |
| Australia, Victoria | |
| Research Site | Recruiting |
| Clayton, Victoria, Australia | |
| Research Site | Recruiting |
| East Melbourne, Victoria, Australia | |
| Australia, Western Australia | |
| Research Site | Recruiting |
| Freemantle, Western Australia, Australia | |
| Research Site | Recruiting |
| Nedlands, Western Australia, Australia | |
| Research Site | Recruiting |
| Perth, Western Australia, Australia | |
| Austria | |
| Research Site | Recruiting |
| Graz, Austria | |
| Research Site | Recruiting |
| Innsbruck, Austria | |
| Research Site | Recruiting |
| Linz, Austria | |
| Research Site | Recruiting |
| Salzburg, Austria | |
| Research Site | Recruiting |
| Wien, Austria | |
| Belgium | |
| Research Site | Recruiting |
| Antwerpen, Belgium | |
| Research Site | Recruiting |
| Leuven, Belgium | |
| Research Site | Recruiting |
| Bruxelles, Belgium | |
| Research Site | Recruiting |
| Edegem, Belgium | |
| Research Site | Recruiting |
| Gent, Belgium | |
| Research Site | Recruiting |
| Brugge, Belgium | |
| Research Site | Recruiting |
| Yvoir, Belgium | |
| Brazil | |
| Research Site | Recruiting |
| Goiania - GO, Brazil | |
| Research Site | Recruiting |
| Porto Alegre, Brazil | |
| Research Site | Recruiting |
| Rio de Janeiro, Brazil | |
| Research Site | Recruiting |
| Santo Andre, Brazil | |
| Research Site | Recruiting |
| Sao Paulo, Brazil | |
| Canada | |
| Research Site | Recruiting |
| Hamilton, Canada | |
| Research Site | Recruiting |
| Quebec City, Canada | |
| Canada, Alberta | |
| Research Site | Recruiting |
| Edmonton, Alberta, Canada | |
| Canada, Nova Scotia | |
| Research Site | Recruiting |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| Research Site | Recruiting |
| London, Ontario, Canada | |
| Research Site | Recruiting |
| Toronto, Ontario, Canada | |
| Czech Republic | |
| Research Site | Recruiting |
| Brno, Czech Republic | |
| Research Facility | Recruiting |
| Hradec Kralove, Czech Republic | |
| Research Site | Recruiting |
| Prague, Czech Republic | |
| France | |
| Research Site | Recruiting |
| Angers, France | |
| Research Site | Recruiting |
| Bordeaux, France | |
| Research Site | Recruiting |
| Pessac, France | |
| Research Site | Recruiting |
| Lille, France | |
| Research Site | Recruiting |
| Limoges, France | |
| Research Site | Recruiting |
| Nantes, France | |
| Research Site | Recruiting |
| Nice, France | |
| Research Site | Recruiting |
| Le Mans, France | |
| Research Site | Recruiting |
| Rennes, France | |
| Research Site | Recruiting |
| Rouen, France | |
| Research Site | Recruiting |
| Tours, France | |
| Germany | |
| Research Site | Recruiting |
| Augsburg, Germany | |
| Research Site | Recruiting |
| Dessau, Germany | |
| Research Site | Recruiting |
| Frankfurt, Germany | |
| Research Site | Recruiting |
| Greifswald, Germany | |
| Research Site | Recruiting |
| Kiel, Germany | |
| Research Site | Recruiting |
| Wurzburg, Germany | |
| Greece | |
| Research Site | Recruiting |
| Athens, Greece | |
| Research Site | Recruiting |
| Crete, Greece | |
| India | |
| Research Site | Recruiting |
| Ahmedabad, India | |
| Research Site | Recruiting |
| Bangalore, India | |
| Research Site | Recruiting |
| Delhi, India | |
| Research Site | Recruiting |
| Mumbai, India | |
| Research Site | Recruiting |
| Nashik, India | |
| Research Site | Recruiting |
| New Delhi, India | |
| Research Site | Recruiting |
| Pune, India | |
| Research Site | Recruiting |
| Trivandrum, India | |
| Israel | |
| Research Site | Recruiting |
| Ashkelon, Israel | |
| Research Site | Recruiting |
| Haifa, Israel | |
| Research Site | Recruiting |
| Jerusalem, Israel | |
| Research Site | Recruiting |
| Petach Tikva, Israel | |
| Research Site | Recruiting |
| Ramat Gan, Israel | |
| Italy | |
| Research Site | Recruiting |
| Milano, Italy | |
| Research Site | Recruiting |
| Novara, Italy | |
| Research Site | Recruiting |
| Roma, Italy | |
| Research Site | Recruiting |
| Rome, Italy | |
| Research Site | Recruiting |
| Rozzano, Italy | |
| Research Site | Recruiting |
| Torino, Italy | |
| Research site | Recruiting |
| Verona, Italy | |
| Lithuania | |
| Research Site | Recruiting |
| Klaipeda, Lithuania | |
| New Zealand | |
| Research Site | Recruiting |
| Auckland, New Zealand | |
| Research Site | Recruiting |
| Christchurch, New Zealand | |
| Research Site | Recruiting |
| Palmerston North, New Zealand | |
| Research Site | Recruiting |
| Wellington, New Zealand | |
| Poland | |
| Research Site | Recruiting |
| Bialystok, Poland | |
| Research Site | Recruiting |
| Gdansk, Poland | |
| Research Site | Recruiting |
| Katowice, Poland | |
| Research Site | Recruiting |
| Krakow, Poland | |
| Research Site | Recruiting |
| Lodz, Poland | |
| Research Site | Recruiting |
| Szczecin, Poland | |
| Research Site | Recruiting |
| Warszawa, Poland | |
| Portugal | |
| Research Site | Recruiting |
| Almada, Portugal | |
| Research Site | Recruiting |
| Braga, Portugal | |
| Research Site | Recruiting |
| Coimbra, Portugal | |
| Research Site | Recruiting |
| Lisboa, Portugal | |
| Research Site | Recruiting |
| Porto, Portugal | |
| Research Site | Recruiting |
| Viseu, Portugal | |
| Romania | |
| Research Site | Recruiting |
| Brasov, Romania | |
| Research Facility | Recruiting |
| Bucharest, Romania | |
| Research Site | Recruiting |
| Bucharest, Romania | |
| Research Site | Recruiting |
| Iasi, Romania | |
| Russian Federation | |
| Research Site | Recruiting |
| Ekaterinburg, Russian Federation | |
| Research Site | Recruiting |
| Nizhniy Novgorod, Russian Federation | |
| Research Site | Recruiting |
| Obninsk, Russian Federation | |
| Research Site | Recruiting |
| Ryazan, Russian Federation | |
| Research Site | Recruiting |
| Samara, Russian Federation | |
| Research Site | Recruiting |
| Saratov, Russian Federation | |
| Research Site | Recruiting |
| St. Petersburg, Russian Federation | |
| Slovakia | |
| Research Site | Recruiting |
| Banska Bystrica, Slovakia | |
| Research Site | Recruiting |
| Bratislava, Slovakia | |
| Research Site | Recruiting |
| Martin, Slovakia | |
| Spain | |
| Research Site | Recruiting |
| Toledo, Spain | |
| Research Site | Recruiting |
| Murcia, Spain | |
| Research Site | Recruiting |
| Palma de Mallorca, Spain | |
| Research Site | Recruiting |
| Salamanca, Spain | |
| Research Site | Recruiting |
| Madrid, Spain | |
| Research Site | Recruiting |
| Zaragoza, Spain | |
| United Kingdom | |
| Research Site | Recruiting |
| Bath, United Kingdom | |
| Research Site | Recruiting |
| Birmingham, United Kingdom | |
| Research Site | Recruiting |
| Bournemouth, United Kingdom | |
| Research Site | Recruiting |
| Glasgow, United Kingdom | |
| Research Site | Recruiting |
| Leeds, United Kingdom | |
| Research Site | Recruiting |
| Taunton, United Kingdom | |
| Research Site | Recruiting |
| Manchester, United Kingdom | |
| Reseach Site | Recruiting |
| Plymouth, United Kingdom | |
| Research Site | Recruiting |
| Surrey, United Kingdom | |
| Research Site | Recruiting |
| London, United Kingdom | |
More Information
| Responsible Party: | Biogen Idec ( Biogen Idec MD ) |
| Study ID Numbers: | 152CL201 |
| Study First Received: | October 19, 2006 |
| Last Updated: | September 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00391066 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
CLL CD23+/CD20+ B-cell CLL |
|
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immunologic Factors Immune System Diseases Antineoplastic Agents Rituximab Physiological Effects of Drugs Cyclophosphamide Immunosuppressive Agents Pharmacologic Actions |
Leukemia Lymphatic Diseases Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Fludarabine Antirheumatic Agents Leukemia, B-Cell Lymphoproliferative Disorders Alkylating Agents |