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)

简要总结

主要结局

次要结局

• 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)
• 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)
• PFS per investigators' assessment(Up to 5 years from the last participant randomized)
• Number of participants with laboratory abnormalities(Up to 5 years from the last participant randomized)
• Minimal residual disease (MRD)-negativity rate(Up to 5 years from the last participant randomized)
• ORR per investigators' assessment(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)
• Complete response with incomplete bone marrow recovery (CRi)(Up to 5 years from the last participant randomized)
• CRR per investigators' assessment(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)
• 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)
• Mean changes from baseline in the following key HRQoL domains: Physical functioning(Up to 5 years from the last participant randomized)
• Mean changes from baseline in the following key HRQoL domains: Fatigue(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)
• 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)
• Mean changes from baseline in the following key HRQoL domains: Symptom burden(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)(Up to 5 years from the last participant randomized)
• Mean changes from baseline in the following key HRQoL domains: Role functioning(Up to 5 years from the last participant randomized)
• Mean changes from baseline in the following key HRQoL domains: Cognitive functioning(Up to 5 years from the last participant randomized)
• Mean changes from baseline in the following key HRQoL domains: Physical condition/fatigue(Up to 5 years from the last participant randomized)