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
NCT ID: NCT06205290
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2024-01-16
2031-10-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Liso-cel Monotherapy
Liso-cel
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Arm B: Investigator's Choice
Idelalisib
Specified dose on specified days
Rituximab
Specified dose on specified days
Bendamustine
Specified dose on specified days
Interventions
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Liso-cel
Specified dose on specified days
Idelalisib
Specified dose on specified days
Rituximab
Specified dose on specified days
Bendamustine
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Vienna, , Austria
Local Institution - 0113
Yvoir, Namur, Belgium
Local Institution - 0112
Leuven, Vlaams-Brabant, Belgium
Local Institution - 0038
Lyon, Auvergne-Rhône-Alpes, France
Local Institution - 0122
Rennes, Brittany Region, France
Local Institution - 0036
Montpellier, Languedoc-Roussillon, France
Local Institution - 0035
Clermont-Ferrand, , France
Local Institution - 0037
Paris, , France
Local Institution - 0034
Toulouse, , France
Local Institution - 0084
Dresden, Saxony, Germany
Local Institution - 0081
Leipzig, Saxony, Germany
Local Institution - 0083
Kiel, Schleswig-Holstein, Germany
Local Institution - 0082
Cologne, , Germany
Local Institution - 0079
Heidelberg, , Germany
Local Institution - 0080
Ulm, , Germany
Local Institution - 0091
Milan, Milano, Italy
Local Institution - 0088
Bologna, , Italy
Local Institution - 0114
Amsterdam, North 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
Countries
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Related Links
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BMS Clinical Trial Information
Other Identifiers
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CA082-1170
Identifier Type: -
Identifier Source: org_study_id
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