Clinical trial NCT06205290: 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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Keywords: Small Lymphocytic lymphoma
B cell malignancies
CD19+ B cell malignancies
Non-Hodgkin lymphoma
Lead sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Sponsor class: INDUSTRY
Collaborators: name: Celgene Corporation
First posted: 2024-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression Free Survival (PFS) per independent review committee (IRC) assessment
timeFrame: Up to 5 years from the last participant randomized
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 5 years from the last participant randomized
measure: Complete Response Rate (CRR) per IRC assessment
timeFrame: Up to 5 years from the last participant randomized
measure: CRR per investigators' assessment
timeFrame: Up to 5 years from the last participant randomized
measure: Complete response with incomplete bone marrow recovery (CRi)
timeFrame: Up to 5 years from the last participant randomized
measure: Minimal residual disease (MRD)-negativity rate
timeFrame: Up to 5 years from the last participant randomized
measure: Overall Response Rate (ORR) per IRC assessment
timeFrame: Up to 5 years from the last participant randomized
measure: ORR per investigators' assessment
timeFrame: Up to 5 years from the last participant randomized
measure: Duration of Response (DOR) per IRC assessment
timeFrame: Up to 5 years from the last participant randomized
measure: Duration of Complete Response (DOCR) per IRC assessment
timeFrame: Up to 5 years from the last participant randomized
measure: PFS per investigators' assessment
timeFrame: Up to 5 years from the last participant randomized
measure: Progression post next line of treatment (PFS-2)
timeFrame: Up to 5 years from the last participant randomized
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 5 years from the last participant randomized
measure: Number of participants with Adverse Events of Special Interest (AESIs)
timeFrame: Up to 5 years from the last participant randomized
measure: Number of participants with laboratory abnormalities
timeFrame: Up to 5 years from the last participant randomized
measure: 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)
timeFrame: Up to 5 years from the last participant randomized
measure: 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)
timeFrame: Up to 5 years from the last participant randomized
measure: Mean changes from baseline in the following key health-related quality of life (HRQoL) domains: GHS/QoL
timeFrame: Up to 5 years from the last participant randomized
measure: Mean changes from baseline in the following key HRQoL domains: Fatigue
timeFrame: Up to 5 years from the last participant randomized
measure: Mean changes from baseline in the following key HRQoL domains: Physical functioning
timeFrame: Up to 5 years from the last participant randomized
measure: Mean changes from baseline in the following key HRQoL domains: Role functioning
timeFrame: Up to 5 years from the last participant randomized
measure: Mean changes from baseline in the following key HRQoL domains: Cognitive functioning
timeFrame: Up to 5 years from the last participant randomized
measure: Mean changes from baseline in the following key HRQoL domains: Symptom burden
timeFrame: Up to 5 years from the last participant randomized
measure: Mean changes from baseline in the following key HRQoL domains: Physical condition/fatigue
timeFrame: Up to 5 years from the last participant randomized
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Duarte
country: United States
facility: Local Institution - 0023
state: California
city: Sacramento
country: United States
facility: University of California Davis (UC Davis) Comprehensive Cancer Center
state: California
city: Atlanta
country: United States
facility: Local Institution - 0120
state: Georgia
city: Boise
country: United States
facility: St. Luke's Mountain States Tumor Institute : Boise
state: Idaho
city: Iowa City
country: United States
facility: Local Institution - 0058
state: Iowa
city: Saint Matthews
country: United States
facility: Local Institution - 0048
state: Kentucky
city: Minneapolis
country: United States
facility: Local Institution - 0101
state: Minnesota
city: New York
country: United States
facility: Local Institution - 0121
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Austin
country: United States
facility: St. David's South Austin Medical Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Morgantown
country: United States
facility: Local Institution - 0068
state: West Virginia
city: Madison
country: United States
facility: University Hospital and UW Health Clinics
state: Wisconsin
city: Salzburg
country: Austria
facility: Local Institution - 0094
city: Wien
country: Austria
facility: Local Institution - 0093
city: Yvoir
country: Belgium
facility: Local Institution - 0113
state: Namur
city: Leuven
country: Belgium
facility: Local Institution - 0112
state: Vlaams-Brabant
city: Rennes
country: France
facility: Local Institution - 0122
state: Bretagne
city: Montpellier
country: France
facility: Local Institution - 0036
state: Languedoc-Roussillon
city: Lyon
country: France
facility: Local Institution - 0038
state: Rhône-Alpes
city: Clermont-Ferrand
country: France
facility: Local Institution - 0035
city: Paris
country: France
facility: Local Institution - 0037
city: Toulouse
country: France
facility: Local Institution - 0034
city: Dresden
country: Germany
facility: Local Institution - 0084
state: Sachsen
city: Leipzig
country: Germany
facility: Local Institution - 0081
state: Sachsen
city: Kiel
country: Germany
facility: Local Institution - 0083
state: Schleswig-Holstein
city: Heidelberg
country: Germany
facility: Local Institution - 0079
city: Köln
country: Germany
facility: Local Institution - 0082
city: Ulm
country: Germany
facility: Local Institution - 0080
city: Milan
country: Italy
facility: Local Institution - 0091
state: Milano
city: Bologna
country: Italy
facility: Local Institution - 0088
city: Amsterdam
country: Netherlands
facility: Local Institution - 0114
state: Noord-Holland
city: Groningen
country: Netherlands
facility: Local Institution - 0117
city: Oslo
country: Norway
facility: Local Institution - 0073
city: Barcelona
country: Spain
facility: Local Institution - 0104
state: Barcelona [Barcelona]
city: L'Hospitalet Del Llobregat
country: Spain
facility: Local Institution - 0105
state: Barcelona [Barcelona]
city: Santander
country: Spain
facility: Local Institution - 0107
state: Cantabria
city: Madrid
country: Spain
facility: Local Institution - 0108
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Local Institution - 0106
state: Valenciana, Comunitat
city: Salamanca
country: Spain
facility: Local Institution - 0103
city: Huddinge
country: Sweden
facility: Local Institution - 0071
city: London
country: United Kingdom
facility: Local Institution - 0115
state: London, City Of
city: London
country: United Kingdom
facility: Local Institution - 0109
state: London, City Of
city: Leeds
country: United Kingdom
facility: Local Institution - 0111
city: Oxford
country: United Kingdom
facility: Local Institution - 0110
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: