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Indolent Non-Hodgkin's LymphomasPhase 3BridalveilNCT01732926

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

A Phase 3 study testing Idelalisib, Rituximab and Bendamustine in people with Indolent Non-Hodgkin's Lymphomas, run by Gilead Sciences at 144 sites in 15 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 addition of idelalisib to bendamustine/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?
Idelalisib, Rituximab and Bendamustine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
475 participants
Where
144 sitesin 15 countries
Study dates
2 Jan 2013to 17 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)
  • 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.
  • Prior treatment with bendamustine that was not effective.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

144 sites in 15 countries.

144 sites in 15 countries

United States33 sites

  • Comprehensive Blood and Cancer Center (Bakersfield)

    Bakersfield, California, 93309

  • Texas Oncology, P.A.

    Bedford, Texas, 76022

  • Ironwood Cancer and Research Center

    Chandler, Arizona, 85224

  • Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Sylvester Comprehensive Cancer Center/UMHC

    Deerfield Beach, Florida, 33442

  • Texas Oncology, P.A.

    Denton, Texas, 76210

  • North Shore Hematology/Oncology Associates

    East Setauket, New York, 11733

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Saint Jude Heritage Healthcare (TORI)

    Fullerton, California, 92835

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54308

  • Bon Secours Saint Francis Hospital

    Greenville, South Carolina, 29607

  • Texas Oncology, P.A.

    Harlingen, Texas, 78550-8321

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • Joliet Oncology Hematology Associates Ltd.

    Joliet, Illinois, 60435

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Northwest Georgia Oncology Centers, PC

    Marietta, Georgia, 30060

  • Signal Point Clinical Research Center, LLC

    Middletown, Ohio, 45042

  • Froedtert Hospital and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Weill Cornell Medical College

    New York, New York, 10065

  • Cancer Care Associates

    Redondo Beach, California, 90277

  • San Luis Obispo Oncology and Hematology

    San Luis Obispo, California, 93401

  • Cancer Center of Santa Barbara

    Santa Barbara, California, 93105

  • Central Coast Medical Oncology Group

    Santa Maria, California, 93454

  • St Joseph Heritage Healthcare System

    Santa Rosa, California, 95403

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Northwest Medical Specialists

    Tacoma, Washington, 98405

  • Kaiser Permanente Vallejo Medical Center

    Vallejo, California, 94589

  • Texas Oncology, P.A.

    Weslaco, Texas, 78596-6608

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

France16 sites

  • Institut Bergonié

    Bordeaux, Aquitaine, 33076

  • Centre Hospitalier Universitaire Brest

    Brest, 29609

  • Centre Hospitalier de Dunkerque

    Dunkirk, 59385

  • Centre Hospitalier Départmental La Roche sur Yon

    La Roche-sur-Yon, 85925

  • Centre Jean Bernard

    Le Mans, Pays de la Loire Region, 72000

  • Centre Léon Bérard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13273

  • CHR Metz

    Metz, Alsace, 57085

  • Hôpital Hôtel-Dieu

    Nantes, 44093

  • Hôpital Necker-Enfants Malades

    Paris, Île-de-France Region, 75015

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021

  • Centre Henri-Becquerel

    Rouen, Haute-normandie, 76038

  • Centre Hospitalier Universitaire de Strasbourg - Hôpital Hautepierre

    Strasbourg, Alsace, 67098

  • Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau

    Tours, 37044

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

United Kingdom14 sites

  • Kent and Canterbury Hospital

    Canterbury, England, CT1 3NG

  • University Hospital Coventry

    Coventry, England, CV2 2DX

  • Royal Bournemouth General Hospital

    Dorset, England, BH7 7DW

  • Leeds Teaching Hospitals NHS Trust

    Leeds, England, LS9 7TF

  • Barts and The London NHS Trust

    London, England, EC1M 6BQ

  • University College London Hospitals National Health Society Foundation Trust

    London, England, NW1 2PG

  • Guys and Saint Thomas NHS Foundation Trust

    London, England, SE1 9RT

  • Imperial College Healthcare NHS Trust

    London, England, W12 0NN

  • Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • Christie Hospital NHS Foundation Trust

    Manchester, England, M20 4BX

  • Mount Vernon Hospital

    Middlesex, HA6 2RN

  • Oxford University Hospitals NHS Trust

    Oxford, England, OX3 7LE

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Canada12 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • Tom Baker Cancer Center

    Calgary, Alberta, T2N 2T9

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Hôpital Charles Lemoyne

    Greenfield Park, Quebec, J4V 2H1

  • Queen Elizabeth II Health Sciences Centre, Centre for Clinical Research

    Halifax, Nova Scotia, B3H 1V7

  • McGill University Health Centre

    Montreal, Quebec, H4A 3JI

  • Fraser Clinical Trials, Inc.

    New Westminster, British Columbia, V3L 3W4

  • Centre Hospitalier Affilie Universitaire de Quebec

    Québec, Quebec, G1J 1Z4

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • BC Cancer Agency - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, R3E 0V9

Other trials in Canada

Italy11 sites

  • Centro di Riferimento Oncologico di Aviano

    Aviano, 33081

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

    Bologna, 40138

  • Spedali Civili Di Brescia Azienda Ospedaliera

    Brescia, 25123

  • IRCCS Azienda Ospedaliera Universitaria San Martino

    Genova, 16132

  • Ospedale San Raffaele-IRCCS

    Milan, 20132

  • Azienda Ospedaliera Ospedale Niguarda Ca' Granda

    Milan, 20162

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

    Novara, 28100

  • Azienda Ospedaliera Ospedali Riuniti Marche Nord

    Pesaro, 61122

  • Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto

    Piacenza, 29100

  • Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte

    Siena, 53100

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Russia10 sites

  • N. N. Blokhin Russian Cancer Research Center

    Moscow, 115478

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

    Nizhny Novgorod, 603126

  • Ryazan Regional Clinical Hospital

    Ryazan, 390039

  • FGU Russian Scientific Research Institute of Hematology and Transfusiology

    Saint Petersburg, 191024

  • 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, 140012

  • State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1"

    Volgograd, 400138

  • Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, 620102

  • Central City Hospital # 7

    Yekaterinburg, 620137

Other trials in Russia

Australia9 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • 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, South Australia, 5037

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Haematology and Oncology Clinics of Australia Gold Coast

    South Brisbane, Queensland, 4101

Other trials in Australia

Poland9 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Malopolskie Centrum Medyczne S.C.

    Krakow, 30-510

  • Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi

    Lódz, 93-510

  • Szpital Kliniczny nr 1, Katedra i Klinika Hematoonkologii i Transplantacji Szpiku

    Lublin, 20-081

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

    Olsztyn, 10-228

  • Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku

    Słupsk, 76-200

  • Centralny Szpital Kliniczny MSW w Warszawie

    Warsaw, 02-507

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776

  • Centrum Onkologii i Hipertermii

    Warsaw, 02-781

Other trials in Poland

Spain8 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Clínico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, 38320

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fé de Valencia

    Valencia, 46026

Other trials in Spain

Germany5 sites

  • Vivantes Klinikum am Urban

    Berlin, 10967

  • Charite - Campus Virchow

    Berlin, 13353

  • Gemeinschaftspraxis Dres. Söling Und Siehl

    Kassel, Hesse, 34117

  • Klinikum der Ludwig-Maximilians-Universität München

    München, 81377

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

    Villingen-Schwenningen, Baden-Wurttemberg, 78054

Other trials in Germany

Israel4 sites

  • Barzilai Medical Center

    Ashkelon, 78278

  • Soroka University Medical Center

    Beersheba, 84101

  • Rambam Health Corp.

    Haifa, 31096

  • Hadassah Medical Organization, Ein Kerem

    Jerusalem, 91120

Other trials in Israel

South Korea4 sites

  • Dong-A University Medical Center

    Busan, 602-715

  • Seoul National University Hospital

    Seoul, 110-744

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Taiwan4 sites

  • Changhua Christian Hospital

    Changhua, 500

  • China Medical University Hospital

    Taichung, 404

  • National Cheng-Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

Czechia3 sites

  • Fakultní nemocnice Brno

    Brno, 625 00

  • Fakultní nemocnice Hradec Králové

    Hradec Králové, 500 05

  • Fakultní Nemocnice Ostrava

    Ostrava - Poruba, Severomoravsky KRAJ, 708 52

Other trials in Czechia

Sweden2 sites

  • Karolinska Universitetssjukhuset

    Huddinge, Stockholm County, 141 86

  • Länssjukhuset Ryhov

    Jönköping, 551 85

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 Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/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
Idelalisib, Rituximab, Bendamustine, Placebo
Keywords
iNHL, indolent NHL, follicular lymphoma, CAL-101, rituximab, bendamustine, small lymphocytic lymphoma, lymphoplasmacytoid lymphoma, Waldenstrom macroglobulinemia, LPL, WM, Marginal zone lymphoma, MZL, SLL, FL, GS-1101, PI3K inhibitor, 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.

  • IdelalisibDrug

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

    150 mg tablet administered orally twice daily

  • RituximabDrug

    Also called Rituxan®, MabThera®

    375 mg/m^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)

  • BendamustineDrug

    Also called Treanda®

    90 mg/m^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)

  • PlaceboDrug

    Tablet administered orally twice daily

Study groups in NCT01732926
Study groupRoleWhat they receive
Rituximab + Bendamustine + IdelalisibExperimentalParticipants will receive rituximab + bendamustine + idelalisib.
Receives: Drug: Idelalisib; Drug: Rituximab; Drug: Bendamustine
Rituximab + Bendamustine + PlaceboExperimentalParticipants will receive rituximab + bendamustine + placebo.
Receives: Drug: Rituximab; Drug: Bendamustine; Drug: Placebo

What is being measured

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

  1. Progression-free Survival (PFS)

    PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).

Secondary outcomes (4)

  1. Complete Response Rate (CR)

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

  2. Overall Response Rate (ORR)

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

  3. 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.

  4. Overall Survival (OS)

    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 start2 Jan 2013
  3. Primary completion17 May 2016
  4. Study completion17 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
475 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01732926
Sponsor's protocol ID
GS-US-313-0125
Other IDs
2012-004034-42
Acronym
Bridalveil
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 Idelalisib, Rituximab and Bendamustine in people with Indolent Non-Hodgkin's Lymphomas, run by Gilead Sciences at 144 sites in 15 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 144 sites in United States, France, United Kingdom, Canada, Italy and 10 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. 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 (PFS). 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 NCT01732926.

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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