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Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

NCT02044822 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2018-11-19

Study results available
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Summary

The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion.

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

  • B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion

Interventions

DRUG

Idelalisib

150 mg tablets administered orally twice daily

DRUG

Rituximab

375 mg/m\^2 administered intravenously once weekly x 8 weeks

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-06
Primary Completion
2016-04-27
Completion
2016-05-17
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • France
  • Hungary
  • Italy
  • Poland
  • Portugal
  • Romania
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02044822 on ClinicalTrials.gov