Chronic Lymphocytic Leukemia Clinical Trial
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
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 leukemia-cll/" >CLL or SLL, whose disease has failed treatment with both BTKi and BCL2i targeted therapies.
Eligibility Criteria
Inclusion Criteria
Must have what doctors call measurable disease, which will be evaluated before each participant take part of the study.
Must have received both a BTKi and a BCL2i treatment, and their disease must have come back or not responded to treatment, or they must not have been able to tolerate the side-effects of the BTKi and/or BCL2i treatment(s).
Must also have an ECOG performance score of 0 or 1, which means they are able to carry out their normal daily activities without any problems.
Exclusion Criteria
Heart problems.
Bleeding disorders.
Active cancer in their brain.
Other reasons include:.
i) Having certain treatments in the past.
ii) Having certain infections that are not under control.
iii) Having certain brain conditions.
- Other protocol-defined Inclusion/Exclusion criteria apply.
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There are 48 Locations for this study
Gilbert Arizona, 85234, United States
Duarte California, 91010, United States
Sacramento California, 95817, United States
Atlanta Georgia, 30322, United States
Boise Idaho, 83712, United States
Iowa City Iowa, 52242, United States
Saint Matthews Kentucky, 40207, United States
Minneapolis Minnesota, 55455, United States
New York New York, 10029, United States
Stony Brook New York, 11794, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44106, United States
Austin Texas, 78704, United States
Norfolk Virginia, 23502, United States
Morgantown West Virginia, 26506, United States
Madison Wisconsin, 53792, United States
Salzburg , 5020, Austria
Wien , 1090, Austria
Yvoir Namur, 5530, Belgium
Leuven Vlaams-Brabant, 3000, Belgium
Rennes Bretagne, 35033, France
Montpellier Languedoc-Roussillon, 34295, France
Lyon Rhône-Alpes, 69008, France
Clermont-Ferrand , 63100, France
Paris , 75013, France
Toulouse , 31100, France
Dresden Sachsen, 01307, Germany
Leipzig Sachsen, 04103, Germany
Kiel Schleswig-Holstein, 24105, Germany
Heidelberg , D-691, Germany
Köln , 50937, Germany
Ulm , 89081, Germany
Milan Milano, 20162, Italy
Bologna , 40138, Italy
Amsterdam Noord-Holland, 1105 , Netherlands
Groningen , 9713 , Netherlands
Oslo , 0372, Norway
Barcelona Barcelona [Barcelona], 08035, Spain
L'Hospitalet Del Llobregat Barcelona [Barcelona], 08908, Spain
Santander Cantabria, 39008, Spain
Madrid Madrid, Comunidad De, 28034, Spain
Valencia Valenciana, Comunitat, 46010, Spain
Salamanca , 37007, Spain
Huddinge , 141 8, Sweden
London London, City Of, NW1 2, United Kingdom
London London, City Of, SE5 9, United Kingdom
Leeds , LS9 7, United Kingdom
Oxford , 0X3 7, United Kingdom
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