Leukemia, Lymphocytic, Chronic, B-Cell
Conditions
Keywords
Small Lymphocytic lymphoma, B cell malignancies, CD19+ B cell malignancies, Non-Hodgkin lymphoma
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.
Interventions
DRUGIdelalisib
Specified dose on specified days
DRUGRituximab
Specified dose on specified days
DRUGBendamustine
Specified dose on specified days
DRUGFludarabine
Specified dose on specified days
BIOLOGICALLiso-cel
Specified dose on specified days
DRUGCyclophosphamide
Specified dose on specified days
Sponsors
Celgene Corporation
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) per independent review committee (IRC) assessment | Up to 5 years from the last participant randomized |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate (CRR) per IRC assessment | Up to 5 years from the last participant randomized | — |
| 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 | — |
| Overall Survival (OS) | 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) | Up to 5 years from the last participant randomized | 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) |
| 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) | Up to 5 years from the last participant randomized | The following domains on the EORTC QLQ-CLL17 will be assessed: * Symptom burden * Physical condition/fatigue |
| Mean changes from baseline in the following key health-related quality of life (HRQoL) domains: GHS/QoL | Up to 5 years from the last participant randomized | As assessed by EORTC QLQ-C30 |
| Mean changes from baseline in the following key HRQoL domains: Fatigue | Up to 5 years from the last participant randomized | As assessed by EORTC QLQ-C30 |
| Mean changes from baseline in the following key HRQoL domains: Physical functioning | Up to 5 years from the last participant randomized | As assessed by EORTC QLQ-C30 |
| Mean changes from baseline in the following key HRQoL domains: Role functioning | Up to 5 years from the last participant randomized | As assessed by EORTC QLQ-C30 |
| Mean changes from baseline in the following key HRQoL domains: Cognitive functioning | Up to 5 years from the last participant randomized | As assessed by EORTC QLQ-C30 |
| Mean changes from baseline in the following key HRQoL domains: Symptom burden | Up to 5 years from the last participant randomized | As assessed by EORTC QLQ-CLL17 |
| Mean changes from baseline in the following key HRQoL domains: Physical condition/fatigue | Up to 5 years from the last participant randomized | As assessed by EORTC QLQ-CLL17 |
| Number of participants with Adverse Events of Special Interest (AESIs) | Up to 5 years from the last participant randomized | — |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom, United States
Outcome results
None listed