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

Leukemia, Lymphocytic, Chronic, B-Cell Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06205290
• Other study ID #: CA082-1170
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 16, 2024
• Est. completion date: October 13, 2031

Study information

• Verified date: March 2024
• Source: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 13, 2031
• Est. primary completion date: October 13, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma

Intervention

Biological:
• Liso-cel
Specified dose on specified days

Drug:
• 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

Locations

Country	Name	City	State
Austria	Local Institution - 0094	Salzburg
Austria	Local Institution - 0093	Wien
Belgium	Local Institution - 0112	Leuven	Vlaams-Brabant
Belgium	Local Institution - 0113	Yvoir	Namur
France	Local Institution - 0035	Clermont-Ferrand
France	Local Institution - 0038	Lyon	Rhône-Alpes
France	Local Institution - 0036	Montpellier	Languedoc-Roussillon
France	Local Institution - 0037	Paris
France	Local Institution - 0122	Rennes	Bretagne
France	Local Institution - 0034	Toulouse
Germany	Local Institution - 0084	Dresden	Sachsen
Germany	Local Institution - 0079	Heidelberg
Germany	Local Institution - 0083	Kiel	Schleswig-Holstein
Germany	Local Institution - 0082	Köln
Germany	Local Institution - 0081	Leipzig	Sachsen
Germany	Local Institution - 0080	Ulm
Italy	Local Institution - 0088	Bologna
Italy	Local Institution - 0091	Milan	Milano
Netherlands	Local Institution - 0114	Amsterdam	Noord-Holland
Netherlands	Local Institution - 0117	Groningen
Norway	Local Institution - 0073	Oslo
Spain	Local Institution - 0104	Barcelona	Barcelona [Barcelona]
Spain	Local Institution - 0105	L'Hospitalet Del Llobregat	Barcelona [Barcelona]
Spain	Local Institution - 0108	Madrid	Madrid, Comunidad De
Spain	Local Institution - 0103	Salamanca
Spain	Local Institution - 0107	Santander	Cantabria
Spain	Local Institution - 0106	Valencia	Valenciana, Comunitat
Sweden	Local Institution - 0071	Huddinge
United Kingdom	Local Institution - 0111	Leeds
United Kingdom	Local Institution - 0109	London	London, City Of
United Kingdom	Local Institution - 0115	London	London, City Of
United Kingdom	Local Institution - 0110	Oxford
United States	Local Institution - 0120	Atlanta	Georgia
United States	St. David's South Austin Medical Center	Austin	Texas
United States	St. Luke's Mountain States Tumor Institute : Boise	Boise	Idaho
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Local Institution - 0023	Duarte	California
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Local Institution - 0058	Iowa City	Iowa
United States	University Hospital and UW Health Clinics	Madison	Wisconsin
United States	Local Institution - 0101	Minneapolis	Minnesota
United States	Local Institution - 0068	Morgantown	West Virginia
United States	Local Institution - 0121	New York	New York
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	University of California Davis (UC Davis) Comprehensive Cancer Center	Sacramento	California
United States	Local Institution - 0048	Saint Matthews	Kentucky
United States	Stony Brook University	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company	Celgene Corporation

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  France,  Germany,  Italy,  Netherlands,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) per independent review committee (IRC) assessment		Up to 5 years from the last participant randomized
Secondary	Overall Survival (OS)		Up to 5 years from the last participant randomized
Secondary	Complete Response Rate (CRR) per IRC assessment		Up to 5 years from the last participant randomized
Secondary	CRR per investigators' assessment		Up to 5 years from the last participant randomized
Secondary	Complete response with incomplete bone marrow recovery (CRi)		Up to 5 years from the last participant randomized
Secondary	Minimal residual disease (MRD)-negativity rate		Up to 5 years from the last participant randomized
Secondary	Overall Response Rate (ORR) per IRC assessment		Up to 5 years from the last participant randomized
Secondary	ORR per investigators' assessment		Up to 5 years from the last participant randomized
Secondary	Duration of Response (DOR) per IRC assessment		Up to 5 years from the last participant randomized
Secondary	Duration of Complete Response (DOCR) per IRC assessment		Up to 5 years from the last participant randomized
Secondary	PFS per investigators' assessment		Up to 5 years from the last participant randomized
Secondary	Progression post next line of treatment (PFS-2)		Up to 5 years from the last participant randomized
Secondary	Number of participants with Adverse Events (AEs)		Up to 5 years from the last participant randomized
Secondary	Number of participants with Adverse Events of Special Interest (AESIs)		Up to 5 years from the last participant randomized
Secondary	Number of participants with laboratory abnormalities		Up to 5 years from the last participant randomized
Secondary	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: Fatigue; Physical functioning; Role functioning; Cognitive functioning; Global health status/quality of life (GHS/QoL)	Up to 5 years from the last participant randomized
Secondary	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: Symptom burden; Physical condition/fatigue	Up to 5 years from the last participant randomized
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting