A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

May 1, 2019 updated by: Gilead Sciences

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia

This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.

Study Overview

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Creteil, France, 94010
        • Hopital Henri Mondor
      • Lille, France, 59045
        • Centre Hospitalier Régional Universitaire de Lille (CHRU)
      • Mulhouse, France, 68100
        • Hôpital Emile Muller
      • Pierre Benite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Rennes, France, 35019
        • Hopital Pontchaillou
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Toulouse, France, 31059
        • Hopital Purpan
      • Dresden, Germany, 1307
        • Gemeinschaftspraxis Hämatologie-Onkologie
      • Erlangen, Germany, 91052
        • Internistische Gemeinschaftspraxis
      • Köln, Germany, 50937
        • Universitatsklinikum Koln
      • Mutlangen, Germany, 73557
        • Stauferklinikum Schwab. Gmund
      • Neunkirchen, Germany, 66538
        • Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth
      • Ulm, Germany, 89081
        • Universitatsklinikum Ulm
      • Cagliari, Italy, 9121
        • Ospedale Oncologico Regionale A. Businco
      • Milano, Italy, 20132
        • Ospedale San Raffaele s.r.l.
      • Torino, Italy, 10126
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
      • Cardiff, United Kingdom, CF14 4XW
        • University Hospital of Wales
      • Cottingham, United Kingdom, HU10 6ED
        • Castle Hill Hospital
      • Dorchester, United Kingdom, DT1 2JY
        • Dorset County Hospital
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Harrow, United Kingdom, HA1 3UJ
        • Northwick Park Hospital
      • Leeds, United Kingdom, LS9 7TF
        • St James's University Hospital
      • Liverpool, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, W1G 6AD
        • Sarah Cannon Research Institute UK
      • London, United Kingdom, W12 0NN
        • Hammersmith Hospital
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Orpington, United Kingdom, BR6 8ND
        • Princess Royal University Hospital
      • Salisbury, United Kingdom, SP2 8BJ
        • Salisbury District Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
      • Swindon, United Kingdom, SN3 6BB
        • Great Western Hospital
      • Torquay, United Kingdom, TQ2 7AA
        • Torbay District General Hospital
      • Truro, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital
      • Yeovil, United Kingdom, BA21 4AT
        • Yeovil District Hospital
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Clearview Cancer Institute
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology Associates
    • California
      • La Jolla, California, United States, 92093
        • University of California, San Diego- Moores Cancer Center
      • Oxnard, California, United States, 93030
        • Ventura County Hematology Oncology Specialists
      • Santa Monica, California, United States, 90404
        • UCLA
      • Stanford, California, United States, 94305
        • Stanford Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Blood and Marrow Transplant Program
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University Medical Center Lombardi Cancer Center
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Collaborative Medical Research Corporation
      • Boynton Beach, Florida, United States, 33435
        • Collaborative Research Group LLC
      • Fort Myers, Florida, United States, 33916
        • Florida Cancer Specialists
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute at Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Morristown, New Jersey, United States, 07962
        • Hematology Oncology Associates of Northern New Jersey
    • New York
      • New Hyde Park, New York, United States, 11042
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Willamette Valley Cancer Center
      • Tualatin, Oregon, United States, 97062
        • Northwest Cancer Specialists, PC
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Cancer Center
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology, P.A.
      • Houston, Texas, United States, 77030
        • M.D. Anderson Cancer Center
      • San Antonio, Texas, United States, 78217
        • Cancer Care Network of South Texas
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
      • Roanoke, Virginia, United States, 24014
        • Oncology and Hematology Associates of Southwest Virginia, Inc
    • Washington
      • Seattle, Washington, United States, 98109-1024
        • Seattle Cancer Care Alliance
      • Yakima, Washington, United States, 98902
        • Yakima Valley Memorial Hospital / North Star Lodge
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College Of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • Adult subjects with previously treated recurrent CLL who have measurable lymphadenopathy
  • Require therapy for CLL
  • Have experienced CLL progression < 24 months since the completion of the last prior therapy
  • Currently not sufficiently fit to receive cytotoxic therapy because of chemotherapy-induced bone marrow damage or comorbidities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Idelalisib + rituximab
Participants will receive idelalisib plus rituximab
Idelalisib 150 mg tablet administered orally twice daily
Other Names:
  • Zydelig®
  • GS-1101
  • CAL 101
Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter
Other Names:
  • Rituxan®
Placebo Comparator: Placebo + rituximab
Participants will receive placebo to match idelalisib plus rituximab
Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter
Other Names:
  • Rituxan®
Placebo to match idelalisib administered orally twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: Up to 17 months
Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.
Up to 17 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Up to 17 months

Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.

Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.

Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors.

Up to 17 months
Lymph Node Response Rate
Time Frame: Up to 17 months
Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the SPD of index lymph nodes.
Up to 17 months
Overall Survival
Time Frame: Up to 17 months
Overall survival was defined as the interval from randomization to death from any cause.
Up to 17 months
Complete Response Rate
Time Frame: Up to 17 months
Complete response rate was defined as the percentage of participants who achieved a complete response.
Up to 17 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Thomas Jahn, MD, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

February 12, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (Estimate)

February 27, 2012

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 1, 2019

Last Verified

April 1, 2015

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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