NCT02258529

Brief Summary

The primary objective of this study is to evaluate the overall response rate (ORR) and complete response (CR) rate to treatment with idelalisib in combination with rituximab in previously untreated adults with follicular lymphoma (FL) or small lymphocytic lymphoma (SLL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

September 14, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2016

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2016

Completed
1 year until next milestone

Results Posted

Study results publicly available

May 18, 2017

Completed
Last Updated

May 14, 2019

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

October 3, 2014

Results QC Date

April 11, 2017

Last Update Submit

May 1, 2019

Conditions

Follicular LymphomaSmall Lymphocytic Lymphoma

Keywords

CancerIndolent Non-Hodgkin LymphomaFLSLL

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate

    Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response during idelalisib treatment. ORR was to be assessed by an independent review committee (IRC).

Secondary Outcomes (8)

  • Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death

    Up to 24 weeks plus 30 days

  • Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings

    Up to 24 weeks plus 30 days

  • Idelalisib Trough and Peak Plasma Concentrations

    Predose and 1.5 hour postdose at Weeks 2, 4, and 12

  • Time to Response

  • Duration of Response

  • +3 more secondary outcomes

Study Arms (1)

Idelalisib + rituximab

EXPERIMENTAL

Idelalisib + rituximab for up to 104 weeks

Drug: IdelalisibBiological: Rituximab

Interventions

IdelalisibDRUG

150 tablets administered orally twice daily

Also known as: Zydelig®, GS-1101
Idelalisib + rituximab
RituximabBIOLOGICAL

375 mg/m\^2 administered intravenously (weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)

Also known as: Rituxan®, MabThera®
Idelalisib + rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed diagnosis of B-cell lymphoma
  • No previous systemic treatment for lymphoma
  • Subject demonstrates need for treatment for lymphoma
  • Ann-Arbor Stage 2 (noncontiguous), 3, or 4 disease
  • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
  • Adequate performance status
  • Required baseline laboratory data within protocol-specified parameters

You may not qualify if:

  • Known history of transformed lymphoma or diffuse large cell lymphoid malignancy
  • Known history of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma
  • Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
  • Known history of drug-induced liver injury, chronic active hepatitis B (HBV), chronic active hepatitis C (HCV), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis
  • Ongoing inflammatory bowel disease
  • Known human immunodeficiency virus (HIV) infection
  • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
  • Ongoing immunosuppressive therapy, including systemic corticosteroids (\> 10 mg prednisone or equivalent/day) with the exception of the use of topical, enteric, or inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for autoimmune anemia and/or thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33916, United States

Location

St. Agnes Hospital

Baltimore, Maryland, 21229, United States

Location

Prarie Lakes Health Care Systems, Inc.

Watertown, South Dakota, 57201, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Lymphoma, FollicularLeukemia, Lymphocytic, Chronic, B-CellNeoplasms

Interventions

idelalisibRituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Limitations and Caveats

Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.

Results Point of Contact

Title
Clinical Trial Disclosures
Organization
Gilead Sciences
ClinicalTrialDisclosures@gilead.com

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2014

First Posted

October 7, 2014

Study Start

September 14, 2015

Primary Completion

April 12, 2016

Study Completion

May 3, 2016

Last Updated

May 14, 2019

Results First Posted

May 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
18 months after study completion
Access Criteria
A secured external environment with username, password, and RSA code.
More information

Locations

US(6)