Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia

Gilead Sciences

Status and phase: Terminated; Phase 3

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Placebo; Drug: Bendamustine; Drug: Rituximab; Drug: Idelalisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01980888

2013-003313-17 (EudraCT Number)

GS-US-312-0123

Details and patient eligibility

About

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).

Enrollment: 311 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

311 participants in 2 patient groups, including a placebo group

Idelalisib+bendamustine+rituximab

Experimental group

Description:

Participants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.

Treatment:

Drug: Bendamustine

Drug: Idelalisib

Drug: Rituximab

Placebo+bendamustine+rituximab

Placebo Comparator group

Description:

Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.

Treatment:

Drug: Bendamustine

Drug: Rituximab

Drug: Placebo