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Business objectives have changed.
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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Liso-cel Monotherapy | Experimental |
| |
| Arm B: Investigator's Choice | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liso-cel | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) per independent review committee (IRC) assessment | Up to 5 years from the last participant randomized |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to 5 years from the last participant randomized | |
| Complete Response Rate (CRR) per IRC assessment | Up to 5 years from the last participant randomized | |
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Inclusion Criteria
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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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Local Institution - 0023 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
See plan description
See plan description
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| Idelalisib | Drug | Specified dose on specified days |
|
|
| Rituximab | Drug | Specified dose on specified days |
|
|
| Bendamustine | Drug | Specified dose on specified days |
|
|
| Fludarabine | Drug | Specified dose on specified days |
|
|
| Cyclophosphamide | Drug | Specified dose on specified days |
|
|
| CRR per investigators' assessment |
| Up to 5 years from the last participant randomized |
| Complete response with incomplete bone marrow recovery (CRi) | Up to 5 years from the last participant randomized |
| Minimal residual disease (MRD)-negativity rate | Up to 5 years from the last participant randomized |
| Overall Response Rate (ORR) per IRC assessment | Up to 5 years from the last participant randomized |
| ORR per investigators' assessment | Up to 5 years from the last participant randomized |
| Duration of Response (DOR) per IRC assessment | Up to 5 years from the last participant randomized |
| Duration of Complete Response (DOCR) per IRC assessment | Up to 5 years from the last participant randomized |
| PFS per investigators' assessment | Up to 5 years from the last participant randomized |
| Progression post next line of treatment (PFS-2) | Up to 5 years from the last participant randomized |
| Number of participants with Adverse Events (AEs) | Up to 5 years from the last participant randomized |
| Number of participants with Adverse Events of Special Interest (AESIs) | Up to 5 years from the last participant randomized |
| Number of participants with laboratory abnormalities | Up to 5 years from the last participant randomized |
| Time from randomization to first confirmed clinically meaningful improvement from baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) | The following domains on the EORTC QLQ-C30 will be assessed:
| Up to 5 years from the last participant randomized |
| Time from randomization to first confirmed clinically meaningful improvement from baseline in the European Quality of Life Module Chronic Lymphocytic Leukemia 17 (EORTC QLQ-CLL17) | The following domains on the EORTC QLQ-CLL17 will be assessed:
| Up to 5 years from the last participant randomized |
| Mean changes from baseline in the following key health-related quality of life (HRQoL) domains: GHS/QoL | As assessed by EORTC QLQ-C30 | Up to 5 years from the last participant randomized |
| Mean changes from baseline in the following key HRQoL domains: Fatigue | As assessed by EORTC QLQ-C30 | Up to 5 years from the last participant randomized |
| Mean changes from baseline in the following key HRQoL domains: Physical functioning | As assessed by EORTC QLQ-C30 | Up to 5 years from the last participant randomized |
| Mean changes from baseline in the following key HRQoL domains: Role functioning | As assessed by EORTC QLQ-C30 | Up to 5 years from the last participant randomized |
| Mean changes from baseline in the following key HRQoL domains: Cognitive functioning | As assessed by EORTC QLQ-C30 | Up to 5 years from the last participant randomized |
| Mean changes from baseline in the following key HRQoL domains: Symptom burden | As assessed by EORTC QLQ-CLL17 | Up to 5 years from the last participant randomized |
| Mean changes from baseline in the following key HRQoL domains: Physical condition/fatigue | As assessed by EORTC QLQ-CLL17 | Up to 5 years from the last participant randomized |
| Duarte |
| California |
| 91010 |
| United States |
| University of California Davis (UC Davis) Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| Local Institution - 0120 | Atlanta | Georgia | 30322 | United States |
| St. Luke's Mountain States Tumor Institute : Boise | Boise | Idaho | 83712 | United States |
| Local Institution - 0058 | Iowa City | Iowa | 52242 | United States |
| Local Institution - 0048 | Saint Matthews | Kentucky | 40207 | United States |
| Local Institution - 0101 | Minneapolis | Minnesota | 55455 | United States |
| Local Institution - 0121 | New York | New York | 10029 | United States |
| Stony Brook University | Stony Brook | New York | 11794 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| St. David's South Austin Medical Center | Austin | Texas | 78704 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Local Institution - 0068 | Morgantown | West Virginia | 26506 | United States |
| University Hospital and UW Health Clinics | Madison | Wisconsin | 53792 | United States |
| Local Institution - 0094 | Salzburg | 5020 | Austria |
| Local Institution - 0093 | Vienna | 1090 | Austria |
| Local Institution - 0113 | Yvoir | Namur | 5530 | Belgium |
| Local Institution - 0112 | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Local Institution - 0038 | Lyon | Auvergne-Rhône-Alpes | 69008 | France |
| Local Institution - 0122 | Rennes | Brittany Region | 35033 | France |
| Local Institution - 0036 | Montpellier | Languedoc-Roussillon | 34295 | France |
| Local Institution - 0035 | Clermont-Ferrand | 63100 | France |
| Local Institution - 0037 | Paris | 75013 | France |
| Local Institution - 0034 | Toulouse | 31100 | France |
| Local Institution - 0084 | Dresden | Saxony | 01307 | Germany |
| Local Institution - 0081 | Leipzig | Saxony | 04103 | Germany |
| Local Institution - 0083 | Kiel | Schleswig-Holstein | 24105 | Germany |
| Local Institution - 0082 | Cologne | 50937 | Germany |
| Local Institution - 0079 | Heidelberg | D-69120 | Germany |
| Local Institution - 0080 | Ulm | 89081 | Germany |
| Local Institution - 0091 | Milan | Milano | 20162 | Italy |
| Local Institution - 0088 | Bologna | 40138 | Italy |
| Local Institution - 0114 | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Local Institution - 0117 | Groningen | 9713 GZ | Netherlands |
| Local Institution - 0073 | Oslo | 0372 | Norway |
| Local Institution - 0104 | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Local Institution - 0105 | L'Hospitalet Del Llobregat | Barcelona [Barcelona] | 08908 | Spain |
| Local Institution - 0107 | Santander | Cantabria | 39008 | Spain |
| Local Institution - 0108 | Madrid | Madrid, Comunidad de | 28034 | Spain |
| Local Institution - 0106 | Valencia | Valenciana, Comunitat | 46010 | Spain |
| Local Institution - 0103 | Salamanca | 37007 | Spain |
| Local Institution - 0071 | Huddinge | 141 86 | Sweden |
| Local Institution - 0115 | London | London, City of | NW1 2PG | United Kingdom |
| Local Institution - 0109 | London | London, City of | SE5 9RS | United Kingdom |
| Local Institution - 0111 | Leeds | LS9 7TF | United Kingdom |
| Local Institution - 0110 | Oxford | 0X3 7LE | United Kingdom |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| C552946 | idelalisib |
| D000069283 | Rituximab |
| D000069461 | Bendamustine Hydrochloride |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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