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Indolent Non-Hodgkin's LymphomasPhase 3YosemiteNCT01732913

Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

A Phase 3 study testing Rituximab and Idelalisib in people with Indolent Non-Hodgkin's Lymphomas, run by Gilead Sciences at 103 sites in 19 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Indolent Non-Hodgkin's Lymphomas
What is being tested?
Rituximab and Idelalisib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
295 participants
Where
103 sitesin 19 countries
Study dates
16 Jan 2013to 18 May 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following:
  • Follicular lymphoma (FL) Grade 1, 2, or 3a
  • Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 10^9/L at the time of diagnosis
  • Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
  • Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

Who cannot join

  • History of lymphoid malignancy other than those allowed per inclusion criteria
  • Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B , alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
  • Received previous treatment with rituximab that was not effective.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

103 sites in 19 countries.

103 sites in 19 countries

United States32 sites

  • Texas Oncology, P.A.

    Bedford, Texas, 76022

  • Ironwood Cancer and Research Center

    Chandler, Arizona, 85224

  • Tennessee Oncology, PLLC

    Chattanooga, Tennessee, 37404

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Wayne State University

    Detroit, Michigan, 48201

  • City of Hope Cancer Center

    Duarte, California, 91010

  • Florida Cancer Specialists and Research Institute

    Fort Myers, Florida, 33916

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Center for Cancer and Blood Disorders, PC

    Fort Worth, Texas, 76104

  • Saint Jude Heritage Healthcare

    Fullerton, California, 92835

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169-3321

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Middlesex Hospital Cancer Center

    Middletown, Connecticut, 06457

  • Signal Point Clinical Research Center, LLC

    Middletown, Ohio, 45042

  • Froedtert Hospital and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Weill Cornell Medical College

    New York, New York, 10065

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • Cancer Care Associates

    Redondo Beach, California, 90277

  • Cancer Center of Santa Barbara

    Santa Barbara, California, 93105

  • Central Coast Medical Oncology Group

    Santa Maria, California, 93454

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Prairie Lakes Healthcare System

    Watertown, South Dakota, 57252

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Shenandoah Oncology Associates, PC

    Winchester, Virginia, 22601

Other trials in United States

Japan13 sites

  • National Hospital Organization Kumamoto Medical Center

    Chuo-ku, Kumamoto, 860-0008

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 1040045

  • Tokai University Hospital

    Isehara-shi, Kanagawa, 259-1193

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, 135-8550

  • National Hospital Organization Kyushu Cancer Center

    Minamiku, Fukuoka, 811-1395

  • Toranomon Hospital

    Minato-ku, Tokyo, 1058470

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, 4600001

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8681

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • Osaka City University Hospital

    Osaka, Osaka, 545-8586

  • Tohoku University Hospital

    Sendai, Miyagi, 9808574

Other trials in Japan

France10 sites

  • Centre Hospitalier Universitaire Brest

    Brest, 29609

  • Centre Hospitalier de Dunkerque

    Dunkirk, 59385

  • Centre Hospitalier de Versailles

    Le Chesnay, 78157

  • Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

    Lille, Hauts-de-France, 59037

  • Centre Léon Bérard

    Lyon, 69373

  • Hôpital Hôtel-Dieu

    Nantes, 44093

  • Hôpital Necker-Enfants Malades

    Paris, Île-de-France Region, 75015

  • University Hospital of Bordeaux

    Pessac, Aquitaine, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie

    Poitiers, 86000

Other trials in France

Australia8 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Saint Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Western Hospital

    Footscray, Victoria, 3011

  • Adelaide Cancer Centre

    Kurralta Park, SA 5037

  • Haematology and Oncology Clinics of Australia at Chermside

    Milton, Queensland, 4064

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Royal Perth Hospital

    Perth, Western Australia, 6000

Other trials in Australia

Russia6 sites

  • Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko

    Nizhny Novgorod, 603126

  • Ryazan Regional Clinical Hospital

    Ryazan, 390039

  • Saint Petersburg I.P. Pavlov State Medical University

    Saint Petersburg, 197022

  • FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies"

    Saint Petersburg, 197341

  • Saratov State Medical University

    Saratov, 410 028

  • Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, 620102

Other trials in Russia

Hungary5 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Országos Onkológiai Intézet

    Budapest, 1122

  • Debreceni Egyetem Orvos-és Egészségtudományi Centrum

    Debrecen, Hajdú-Bihar, 4032

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, Somogy County, 7400

  • Markusovszky Egyetemi Oktatókórház

    Szombathely, Vas County, 9700

Other trials in Hungary

Italy5 sites

  • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

    Bologna, 40138

  • Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara

    Novara, 28100

  • Azienda Ospedaliera Ospedali Riuniti Marche Nord

    Pesaro, 61100

  • Centro di Riferimento Oncologico di Aviano

    Pordenone, 33081

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Poland3 sites

  • Malopolskie Centrum Medyczne S.C.

    Krakow, 30-510

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim

    Olsztyn, 10-228

  • Centrum Onkologii i Hipertermii

    Warsaw, 02-781

Other trials in Poland

Singapore3 sites

  • Singapore General Hospital

    Singapore, 169608

  • National Cancer Centre Singapore

    Singapore, 169610

  • Gleneagles Medical Centre

    Singapore, 258500

Other trials in Singapore

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 110-744

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-876

Other trials in South Korea

United Kingdom3 sites

  • Barts and The London NHS Trust

    London, England, EC1A 7BE

  • Mount Vernon Hospital

    Middlesex, HA6 2RN

  • Sunderland Royal Infirmary

    Sunderland, SR4 7TP

Other trials in United Kingdom

Germany2 sites

  • Gemeinschaftspraxis Dres. Söling Und Siehl

    Kassel, Hesse, 34119

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

    Villingen-Schwenningen, Baden-Wurttemberg, 78052

Other trials in Germany

Israel2 sites

  • Hadassah Medical Organization, Ein Kerem

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 49100

Other trials in Israel

Spain2 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

Other trials in Spain

Taiwan2 sites

  • Chang Gung Memorial Hospital (CGMH)

    Kaohsiung City, 83301

  • Tri-Service General Hospital

    Taipei, 11490

Other trials in Taiwan

Czechia1 site

  • Fakultní nemocnice Hradec Králové

    Hradec Králové, 500 05

Other trials in Czechia

Portugal1 site

  • Hospital Geral de Santo António do Centro Hospitalar do Porto

    Porto, 4099-001

Other trials in Portugal

Romania1 site

  • Institutul Clinic Fundeni

    Bucharest, 022328

Other trials in Romania

Sweden1 site

  • Skånes Universitetssjukhus, Malmö

    Malmö, 205 02

Other trials in Sweden

About this study

Official title: 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 Indolent Non-Hodgkin Lymphomas

The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line 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).

Being tested
Placebo, Rituximab, Idelalisib
Keywords
iNHL, indolent NHL, follicular lymphoma, CAL-101, Rituximab, Small lymphocytic lymphoma, lymphoplasmacytoid lymphoma, Waldenstrom macroglobulinemia, LPL, WM, Marginal zone lymphoma, MZL, SLL, FL, GS-1101, idelalisib
Medical subject headings
Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell, Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Tablets administered orally twice daily

  • RituximabDrug

    Also called Rituxan®, MabThera®

    375 mg/m^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions)

  • IdelalisibDrug

    Also called GS-1101, CAL-101, Zydelig®

    150 mg tablets administered orally twice daily

Study groups in NCT01732913
Study groupRoleWhat they receive
Rituximab + idelalisibExperimentalParticipants will receive rituximab + idelalisib.
Receives: Drug: Rituximab; Drug: Idelalisib
Rituximab + PlaceboPlacebo comparatorParticipants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.
Receives: Drug: Placebo; Drug: Rituximab; Drug: Idelalisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).

Secondary outcomes (4)

  1. Overall Response Rate

    Overall Response Rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response or minor response for participants with Waldenstrom's). ORR was to be assessed by an IRC.

  2. Lymph Node Response Rate

    Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.

  3. Complete Response Rate

    Complete response rate is defined as the proportion of participants who achieve a complete response. Complete response rate was to be assessed by an IRC.

  4. Overall Survival

    Overall survival is defined as the interval from randomization to death from any cause.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2012 (estimated)
  2. Study start16 Jan 2013
  3. Primary completion18 May 2016
  4. Study completion18 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
295 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01732913
Sponsor's protocol ID
GS-US-313-0124
Acronym
Yosemite
Status last verified
Mar 2017
First submitted
14 Nov 2012
Last updated
16 Nov 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab and Idelalisib in people with Indolent Non-Hodgkin's Lymphomas, run by Gilead Sciences at 103 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States, Japan, France, Australia, Russia and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01732913.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.

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