Clinical trial · Interventional
Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care. An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Idelalisib | Drug | Idelalisib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Idelalisib+bendamustine+rituximab
- description
- Participants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
- interventionNames
- Drug: Idelalisib
- Drug: Bendamustine
- Drug: Rituximab
- type
- PLACEBO_COMPARATOR
- label
- Placebo+bendamustine+rituximab
- description
- Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
- interventionNames
- Drug: Bendamustine
- Drug: Rituximab
- Drug: Placebo
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Documented diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) * No prior therapy for CLL other than corticosteroids for disease complications * CLL that warrants treatment * Presence of measurable lymphadenopathy * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 Key Exclusion Criteria: * Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation) * Known presence of myelodysplastic syndrome * Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization * Ongoing liver injury * History of non-infectious pneumonitis * Ongoing inflammatory bowel disease * History of prior allogeneic bone marrow progenitor cell or solid organ transplantation * Ongoing immunosuppressive therapy other than corticosteroids * Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization Note: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (0)
Data not yet available