Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia

• Status: Terminated
• Trial end date: 2016-05-13
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Chlorambucil; Idelalisib; Obinutuzumab

Criteria

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.