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Brief Title: A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies
Official Title: A Global Phase 3, Randomized, Open-label, Multi-center Trial Designed to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options (Idelalisib + Rituximab or Bendamustine + Rituximab) in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), Whose Disease Has Failed Treatment With Both BTKi and BCL2i Targeted Therapies (A Double Class Exposed Population)
Study ID: NCT06205290
Brief Summary: The purpose of this study is to compare the efficacy and safety of liso-cel vs Investigator's Choice options (idelalisib + rituximab or bendamustine + rituximab) in adult participants with R/R CLL or SLL, whose disease has failed treatment with both BTKi and BCL2i targeted therapies.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Local Institution - 0023, Duarte, California, United States
University of California Davis (UC Davis) Comprehensive Cancer Center, Sacramento, California, United States
Local Institution - 0120, Atlanta, Georgia, United States
St. Luke's Mountain States Tumor Institute : Boise, Boise, Idaho, United States
Local Institution - 0058, Iowa City, Iowa, United States
Local Institution - 0048, Saint Matthews, Kentucky, United States
Local Institution - 0101, Minneapolis, Minnesota, United States
Local Institution - 0121, New York, New York, United States
Stony Brook University, Stony Brook, New York, United States
Oncology Hematology Care, Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
St. David's South Austin Medical Center, Austin, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Local Institution - 0068, Morgantown, West Virginia, United States
University Hospital and UW Health Clinics, Madison, Wisconsin, United States
Local Institution - 0094, Salzburg, , Austria
Local Institution - 0093, Wien, , Austria
Local Institution - 0113, Yvoir, Namur, Belgium
Local Institution - 0112, Leuven, Vlaams-Brabant, Belgium
Local Institution - 0122, Rennes, Bretagne, France
Local Institution - 0036, Montpellier, Languedoc-Roussillon, France
Local Institution - 0038, Lyon, Rhône-Alpes, France
Local Institution - 0035, Clermont-Ferrand, , France
Local Institution - 0037, Paris, , France
Local Institution - 0034, Toulouse, , France
Local Institution - 0084, Dresden, Sachsen, Germany
Local Institution - 0081, Leipzig, Sachsen, Germany
Local Institution - 0083, Kiel, Schleswig-Holstein, Germany
Local Institution - 0079, Heidelberg, , Germany
Local Institution - 0082, Köln, , Germany
Local Institution - 0080, Ulm, , Germany
Local Institution - 0091, Milan, Milano, Italy
Local Institution - 0088, Bologna, , Italy
Local Institution - 0114, Amsterdam, Noord-Holland, Netherlands
Local Institution - 0117, Groningen, , Netherlands
Local Institution - 0073, Oslo, , Norway
Local Institution - 0104, Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0105, L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain
Local Institution - 0107, Santander, Cantabria, Spain
Local Institution - 0108, Madrid, Madrid, Comunidad De, Spain
Local Institution - 0106, Valencia, Valenciana, Comunitat, Spain
Local Institution - 0103, Salamanca, , Spain
Local Institution - 0071, Huddinge, , Sweden
Local Institution - 0115, London, London, City Of, United Kingdom
Local Institution - 0109, London, London, City Of, United Kingdom
Local Institution - 0111, Leeds, , United Kingdom
Local Institution - 0110, Oxford, , United Kingdom
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR