Clinical trial · Interventional
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
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business objectives have changed.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphocytic, Chronic, B-Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Idelalisib | Drug | Idelalisib | ALIAS |
| Liso-cel | Biological | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Liso-cel Monotherapy
- interventionNames
- Biological: Liso-cel
- Drug: Fludarabine
- Drug: Cyclophosphamide
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Investigator's Choice
- interventionNames
- Drug: Idelalisib
- Drug: Rituximab
- Drug: Bendamustine
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) per independent review committee (IRC) assessment
- timeFrame
- Up to 5 years from the last participant randomized
Secondary outcomes (23)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available