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Chronic Lymphocytic LeukemiaPhase 3TugelaNCT01569295

Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )

A Phase 3 study testing Idelalisib, Rituximab and Bendamustine in people with Chronic Lymphocytic Leukemia, run by Gilead Sciences at 106 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Idelalisib, Rituximab and Bendamustine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
416 participants
Where
106 sitesin 18 countries
Study dates
15 Jun 2012to 10 Jun 2019
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

  • Previously treated recurrent CLL
  • Measurable lymphadenopathy
  • Requires therapy for CLL
  • Has experienced CLL progression < 36 months since the completion of the last prior therapy

Who cannot join

  • Recent history of a major non-CLL malignancy
  • Evidence of an ongoing infection
  • CLL refractory to bendamustine
  • Concurrent participation in another therapeutic clinical trial
  • NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial locations and contacts

106 sites in 18 countries.

106 sites in 18 countries

United States23 sites

  • Winship Cancer Institute at Emory University

    Atlanta, Georgia, 30322

  • Texas Oncology

    Austin, Texas, 78731

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Charleston Hematology Oncology

    Charleston, South Carolina, 29414

  • Texas Oncology PA

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97477

  • Texas Oncology

    Fort Worth, Texas, 76104

  • University of Florida

    Gainesville, Florida, 32603

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • UCLA Medical Center

    Los Angeles, California, 90095

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Summit Medical Group, P.A.

    Morristown, New Jersey, 07962

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11042

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10032

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Stanford Cancer Center

    Palo Alto, California, 94035

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Cancer Care Northwest, US Oncology

    Spokane, Washington, 99202

  • Virginia Cancer Specialists, PC

    Vancouver, Washington, 98684

Other trials in United States

United Kingdom15 sites

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • Dorset County Hospital

    Dorchester, DT1 2JY

  • St. James University Hospital

    Leeds, LS9 7TF

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • St Bartholomews Hospital

    London, EC1A 7BE

  • King's College Hospital

    London, SE5 9RS

  • Hammersmith Hospital

    London, W12 0NN

  • University College London

    London, WC1E 6BT

  • Christie Hospital

    Manchester, M20 4BX

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • Churchill Hospital

    Oxford, OX3 7LE

  • Royal Cornwall Hospital

    Truro, TR1 3LJ

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

France9 sites

  • Hopital Henri Mondor

    Créteil, 94010

  • Centre Jean Bernard - Clinique Victor Hugo

    Le Mans, 72015

  • CHRU Lille-Hôpital Claude Huriez

    Lille, 59045

  • Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes

    Lyon, 69373

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68100

  • CHU Hôtel-Dieu-Service Hématologie

    Nantes, 44 093

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Pierre Bénite

  • Hopital Purpan

    Toulouse, 31059

  • Hôpitaux de Brabois

    Vandoeuvre-lés-Nancy, 54511

Other trials in France

Australia7 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Monash Medical Centre - Clayton Campus

    Clayton, Victoria, 3168

  • St Vincent's Hospital - Sydney

    Darlinghurst, New South Wales, 2010

  • Gosford Hospital

    Gosford, New South Wales, 2250

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Poland7 sites

  • Szpital Specjalistyczny w Brzozowie

    Brzozów, 36-200

  • Malopolskie Centrum Medyczne

    Krakow, 30-510

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

    Lodz, 93-510

  • Samodzielny Publiczny Szpital Kliniczny Nr 1

    Lublin, 20-081

  • Wojewodzki Szpital w Opolu

    Opole, 43-372

  • Centralny Szpital Kliniczny MSW w Warszawie

    Warsaw, 02-507

  • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

Russia7 sites

  • Russian Oncology Research Center (N.N. Blokhin)

    Moscow, 115478

  • Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko

    Nizhny Novgorod, 603126

  • Novosibirsk State Regional Clinical Hospital

    Novosibirsk

  • Ryazan Regional Clinical Hospital

    Ryazan, 390039

  • Research Institute of Hematology and Blood Transfusion

    Saint Petersburg, 193024

  • Saratov State Medical University

    Saratov, 410028

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

    Volgograd, 400138

Other trials in Russia

Spain6 sites

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Catalonia, 08916

  • Hospital Clinic de Barcelona

    Barcelona, Catalonia, 8036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 8041

  • Hospital 12 de Octubre

    Madrid, Madrid, Communidad de, 28041

  • Hospital Universitario de La Princesa

    Madrid, 28033

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, Communidad de, 28222

Other trials in Spain

Hungary5 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Országos Onkológiai Intézet

    Budapest, 1122

  • Debreceni Egyetem Orvos- és Egészségtudományi Centrum

    Debrecen, 4032

  • Tallian Gyula utca 20-32

    Kaposvár, 7400

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, 6720

Other trials in Hungary

Italy4 sites

  • Spedali Civili di Brescia

    Brescia, 25123

  • Ospedale Oncologico Regionale A. Businco

    Cagliari, 9121

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliera Universitaria San Giovanni Battista-Molinette

    Torino, 10126

Other trials in Italy

Romania4 sites

  • Emergency County Clinical Hospital Brasov

    Brasov, 500152

  • "Colentina" Clinical Hospital

    Bucharest, 20125

  • "Fundeni" Clinical Institute

    Bucharest, 22328

  • Regional Oncology Institute Iasi

    Iași, 700483

Other trials in Romania

Turkey (Türkiye)4 sites

  • Gazi University Medical Faculty Gazi Hospital

    Ankara, 06500

  • Ankara University Medical Faculty

    Ankara, 6590

  • Istanbul University Istanbul Medical Faculty

    Istanbul, 34093

  • Ondokuz Mayis University Faculty of Medicine

    Samsun, 55239

Other trials in Turkey (Türkiye)

Belgium3 sites

  • Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg

    Antwerp, 2060

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Croatia3 sites

  • Clinical Hospital "Dubrava"

    Zagreb, 10000

  • Klinichki Bolnicki Centar-Zagreb

    Zagreb, 10000

  • University Hospital Merkur

    Zagreb, 10000

Other trials in Croatia

Czechia3 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultní nemocnice Hradec Králové

    Hradec Králové, 500 05

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52

Other trials in Czechia

Greece2 sites

  • G. Genimatas Hospital

    Athens, 11527

  • University General Hospital of Patras

    Pátrai, 26500

Other trials in Greece

Portugal2 sites

  • Hospital Santa Maria

    Lisbon, 1649-035

  • "Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)

    Porto, 4200-072

Other trials in Portugal

Canada1 site

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Ireland1 site

  • Mater Misericordiae Hospital

    Dublin

Other trials in Ireland

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 Chronic Lymphocytic Leukemia

The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)

Being tested
Idelalisib, Rituximab, Bendamustine, Placebo to match idelalisib
Keywords
Zydelig, CLL, CAL-101, GS 1101, GS-1101, PI3K, Rituxan, Rituximab, Bendamustine, Leukemia, idelalisib
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia

What participants receive

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

  • IdelalisibDrug

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

    Idelalisib 150 mg administered orally twice daily

  • RituximabDrug

    Also called Rituxan®, MabThera

    Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a maximum of 6 infusions

  • BendamustineDrug

    Also called Ribomustin, Treanda®

    Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions

  • Placebo to match idelalisibDrug

    Placebo to match idelalisib administered orally twice daily

Study groups in NCT01569295
Study groupRoleWhat they receive
Idelalisib+bendamustine+rituximabExperimentalParticipants will receive idelalisib plus bendamustine and rituximab
Receives: Drug: Idelalisib; Drug: Rituximab; Drug: Bendamustine
Placebo to match idelalisib+bendamustine+rituximabPlacebo comparatorParticipants will receive placebo to match idelalisib plus bendamustine and rituximab
Receives: Drug: Rituximab; Drug: Bendamustine; Drug: Placebo to match idelalisib

What is being measured

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

  1. Progression-Free Survival (PFS)

    PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.

    Measured: Up to 84 months

Secondary outcomes (4)

  1. Overall Response Rate (ORR)

    ORR was the percentage of participants who achieved a complete response (CR), CR with incomplete marrow recovery (CRi,) or partial response (PR) and maintained the response for at least 12 weeks. CR was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate \& biopsy.

    PR 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. CRi was defined as all criteria for CR met but with persistent anemia, thrombocytopenia, neutropenia or a hypocellular bone marrow.

    Measured: Up to 84 months

  2. Lymph Node Response Rate

    Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.

    Measured: Up to 84 months

  3. Overall Survival

    Overall survival (OS) was defined as the interval from randomization to death from any cause. Overall survival (months) = (date of death - date of randomization + 1)/30.4375.

    Measured: Up to 84 months

  4. Complete Response Rate

    Complete response (CR) rate was defined as the percentage of participants who achieved a CR.

    Measured: Up to 84 months

Timeline

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

  1. First posted3 Apr 2012 (estimated)
  2. Study start15 Jun 2012
  3. Primary completion10 Jun 2019
  4. Study completion10 Jun 2019

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
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01569295
Sponsor's protocol ID
GS-US-312-0115
Other IDs
2011-006292-20
Acronym
Tugela
Status last verified
Mar 2020
First submitted
27 Mar 2012
Last updated
10 Mar 2020
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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

Publications

  • Zelenetz AD, Robak T, et al. Idelalisib Plus Bendamustine and Rituximab (BR) Is Superior to BR Alone in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. American Society ofHematology (ASH) 57th Annual Meeting & Exposition; 5-8 December 2015; Orlando, FL.

  • Barrientos JC, Brown JR, et al. Results of a Randomized Double-Blind Placebo-Controlled Phase 3 study Evaluating Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL and Adverse Prognostic Features. American Society of Clinical Oncology (ASCO) 2016 Annual Meeting; 3-7 June 2016; Chicago, IL.

  • Hillmen, P, Ferra C, et al. Idelalisib in Combination with Bendamustine and Rituximab Improves Overall Survival in Patients with Relapsed/Refractory CLL: Interim Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. European Hematology Association (EHA) 21st Annual Meeting; 9-12 June 2016; Copenhagen, Denmark.

  • Zelenetz AD, Brown JR et al. Updated Analysis of Overall Survival in Randomized Phase III Study of Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL. American Society of Hematology (ASH) 58th Annual Meeting & Exposition; 3-6 December 2016; San Diego, CA

  • Zelenetz AD, Barrientos JC, Brown JR, Coiffier B, Delgado J, Egyed M, Ghia P, Illes A, Jurczak W, Marlton P, Montillo M, Morschhauser F, Pristupa AS, Robak T, Sharman JP, Simpson D, Smolej L, Tausch E, Adewoye AH, Dreiling LK, Kim Y, Stilgenbauer S, Hillmen P. Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2017 Mar;18(3):297-311. doi: 10.1016/S1470-2045(16)30671-4. Epub 2017 Jan 28.

    PubMed 28139405

  • Montillo M, Illes A, Robak T, Pristupa AS, Wach M, Egyed M, Delgado J, Jurczak W, Morschhauser F, Schuh A, Eradat H, Shreay S, Barrientos JC, Zelenetz AD. Idelalisib addition has neutral to beneficial effects on quality of life in bendamustine/rituximab-treated patients: results of a phase 3, randomized, controlled trial. Health Qual Life Outcomes. 2019 Nov 15;17(1):173. doi: 10.1186/s12955-019-1232-8.

    PubMed 31729982

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Idelalisib, Rituximab and Bendamustine in people with Chronic Lymphocytic Leukemia, run by Gilead Sciences at 106 sites in 18 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, United Kingdom, France, Australia, Poland and 13 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 27 Feb 2018). 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) (time frame: Up to 84 months). 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 NCT01569295, which also lists 6 linked publications.

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 10 Mar 2020.

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