Clinical trial · Interventional
Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia
A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab 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 effects of idelalisib with obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL). 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 those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorambucil | Drug | Chlorambucil | ALIAS |
| Idelalisib | Drug | Idelalisib | ALIAS |
| Obinutuzumab | Drug | Obinutuzumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Safety Run-In: Idelalisib+obinutuzumab
- description
- Participants will receive idelalisib for 96 weeks and obinutuzumab over 21 weeks. Following 4 weeks of treatment, safety data will be reviewed by an independent data monitoring committee (DMC). If acceptable tolerability is observed, the randomized portion of the study will begin.
- interventionNames
- Drug: Idelalisib
- Drug: Obinutuzumab
- type
- EXPERIMENTAL
- label
- Randomized: Idelalisib+obinutuzumab
- description
- Participants will receive idelalisib for 96 weeks and obinutuzumab over 21 weeks.
- interventionNames
- Drug: Idelalisib
- Drug: Obinutuzumab
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Not a candidate for fludarabine therapy based on either: 1. creatinine clearance \< 70 mL/min, or 2. Cumulative Illness Rating Scale score \> 6, by assessment of the investigator * 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 * Ongoing drug-induced pneumonitis * Ongoing inflammatory bowel disease * History of prior allogeneic bone marrow progenitor cell or solid organ transplantation * Ongoing immunosuppressive therapy other than corticosteroids * Concurrent participation in another therapeutic clinical trial * Undergone major surgery within 30 days prior to randomization * Known hypersensitivity or intolerance to any of the active substances or excipients in the formulations for idelalisib, obinutuzumab, or chlorambucil * History of non-infectious pneumonitis * 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