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

Juno Therapeutics

Status and phase: Withdrawn; Phase 3

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Treatments: Drug: Fludarabine; Biological: Liso-cel; Drug: Bendamustine; Drug: Rituximab; Drug: Idelalisib; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06205290

CA082-1170

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm A: Liso-cel Monotherapy

Experimental group

Treatment:

Drug: Cyclophosphamide

Biological: Liso-cel

Drug: Fludarabine

Arm B: Investigator's Choice

Active Comparator group

Treatment:

Drug: Idelalisib

Drug: Bendamustine

Drug: Rituximab