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Chronic Lymphocytic LeukemiaPhase 3NCT01980888

Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia

A Phase 3 study testing Idelalisib, Bendamustine and Rituximab in people with Chronic Lymphocytic Leukemia, run by Gilead Sciences at 91 sites in 13 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 progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care. 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, Bendamustine and Rituximab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
311 participants
Where
91 sitesin 13 countries
Study dates
5 Feb 2014to 16 Jun 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

  • Documented diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL)
  • No prior therapy for CLL other than corticosteroids for disease complications
  • CLL that warrants treatment
  • Presence of measurable lymphadenopathy
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Who cannot join

  • Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
  • Known presence of myelodysplastic syndrome
  • Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
  • Ongoing liver injury
  • History of non-infectious pneumonitis
  • Ongoing inflammatory bowel disease
Show all 10Show fewer
  • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
  • Ongoing immunosuppressive therapy other than corticosteroids
  • Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

91 sites in 13 countries.

91 sites in 13 countries

United States23 sites

  • Texas Oncology-Austin Midtown

    Austin, Texas, 78705

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Sarah Cannon Research Institute

    Cincinnati, Ohio, 45242

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center

    Fullerton, California, 92835

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • Franciscan Physician Network Oncology & Hematology

    Indianapolis, Indiana, 46237

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89074

  • Signal Point Clinical Research Center

    Middletown, Ohio, 45042

  • Hematology /Oncology Associates of Northern New Jersey

    Morristown, New Jersey, 07962

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Columbia University Medical Center

    New York, New York, 10032

  • University of Rochester

    Rochester, New York, 14642

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84103

  • Central Coast Medical Oncology

    Santa Maria, California, 93454

  • Florida Cancer Specialists-South

    Sarasota, Florida, 34236

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

Australia9 sites

  • Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Flinders Medical Centre, Department of Haematology, Level 6

    Bedford Park, South Australia, 5042

  • St Vincent's Hospital, Sydney

    Darlinghurst, New South Wales, 2010

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Barwon Health, University Hospital Geelong

    Geelong, Victoria, 3220

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

  • Jarrett Street Specialist Centre

    North Gosford, New South Wales, 2250

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Spain9 sites

  • Hospital Vall de Hebron

    Barcelona, Catalonia, 08035

  • Hospital Clinic

    Barcelona, Catalonia, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • ICO, Hospitalet de Llobregat

    Barcelona, 8908

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario Ramón Y Cajal

    Madrid, 28033

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta De Hierro

    Madrid, 28222

Other trials in Spain

United Kingdom9 sites

  • East Kent Hospitals University NHS Foundation Trust

    Canterbury, Kent, CT1 3NG

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • Royal Liverpool & Broadgreen Univ. Hospitals NHS Trust

    Liverpool, L7 8XP

  • University College London

    London, England, WC1E 6BT

  • Hammersmith Hospitals NHS Trust

    London, W12 0HS

  • Oxford University Hospitals

    Oxford, OX37LE

  • University Hospital Southampton NHS Trust

    Southampton, SO16 6YD

  • Royal Marsden NHS Trust

    Sutton, Surrey, SM2 5PT

  • Royal Wolverhampton Hospital NHS Trust, New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Hungary8 sites

  • Semmelweis University

    Budapest, 1083

  • National Institute of Oncology

    Budapest, 1122

  • University of Debrecen HSC Institute of internal Medicine, Department of Hematology

    Debrecen, 4032

  • Pandy Kalman Hospital

    Gyula, 5700

  • Kaposi Mor Oktato Korhaz, Intezeti Gyogyszertar,

    Kaposvár, Somogy County, 7400

  • University Of Pecs, Medical School

    Pécs, 7624

  • Szegedi Tudomanyegyetem AOK - Szent-Gyorgyi Albert Klinikai Kozpont, II. Belgyógyászati Klinika

    Szeged, 6725

  • Szent Borbála Hospital

    Tatabánya, Komárom-Esztergom, 2800

Other trials in Hungary

Poland7 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-952

  • Malopolskie Centrum Medyczne s.c.

    Krakow, 30-510

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika Klinika Hematologii

    Lodz, 93-510

  • Centralny Szpital Kliniczny MSW w Warszawie Klinika Onkologii i Hematologii

    Warsaw, 02-507

  • Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego

    Warsaw, 02-781

  • Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu Klinika i Katedra Hematologii,Nowotworow Krwi i Transplantacji Szpiku

    Wroclaw, 50-367

  • Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

    Wroclaw, 53-439

Other trials in Poland

Canada5 sites

  • Hôpital du Sacré-Coeur de Montréal

    Montreal, Quebec, H4J 1C5

  • CHU de Québec - Hôpital de l'Enfant-Jésus

    Québec, Quebec, G1J 1Z4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2C9

  • Cancercare Manitoba - Maccharles Unit

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Czechia5 sites

  • University Hospital

    Brno, 62500

  • Faculty Hospital Hradec Kralove

    Hradec Králové, 500 05

  • Faculty hospital Ostrava

    Ostrava-Poruba, Moravian-Silesian, 70852

  • Faculty Hospital Plzen

    Pilsen, 304 60

  • Faculty Hospital Kralovske Vinohrady

    Prague, 10034

Other trials in Czechia

Italy5 sites

  • IRCCS Istituto Tumori

    Bari, Apulia, 70024

  • Ospedale Oncologico Armando Businco

    Cagliari, 09121

  • Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliero Universitaria Policlinico di Modena

    Modena, 41124

  • AOU Maggiore della Carità

    Novara, 28100

Other trials in Italy

Belgium3 sites

  • Z N A Stuivenberg

    Antwerp, 2060

  • AZ Sint-Jan AV Brugge-Oostende

    Bruges, 8000

  • University Hospital Leuven

    Leuven, 3000

Other trials in Belgium

Croatia3 sites

  • Klinicka bolnica Dubrava

    Zagreb, 10000

  • Klinicka bolnica Merkur

    Zagreb, 10000

  • UHC Zagreb

    Zagreb, 10000

Other trials in Croatia

France3 sites

  • CHRU de Lille, Hopital Claude Huriez

    Lille, 59037

  • Hospital Saint-Louis

    Paris, 75010

  • CHU Bretonneau

    Tours, 37044

Other trials in France

Romania2 sites

  • Emergency County Clinical Hospital Brasov

    Brasov, 500326

  • Spitalul Clinic Colentina

    Bucharest, 20125

Other trials in Romania

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia

The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care.

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line 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 this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

Being tested
Idelalisib, Bendamustine, Rituximab, Placebo
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • IdelalisibDrug

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

    150 mg tablet administered orally twice daily

  • BendamustineDrug

    Administered intravenously at a starting dose of 90 mg/m^2 for up to 6 cycles. Dosing will be based on mg/m^2 of body surface area.

  • RituximabDrug

    Single-use vials administered intravenously weekly starting at 375 mg/m^2 on Day 1 (Week 0) and 500 mg/m^2 thereafter for a total of 6 infusions

  • PlaceboDrug

    Placebo to match idelalisib administered orally twice daily

Study groups in NCT01980888
Study groupRoleWhat they receive
Idelalisib+bendamustine+rituximabExperimentalParticipants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
Receives: Drug: Idelalisib; Drug: Bendamustine; Drug: Rituximab
Placebo+bendamustine+rituximabPlacebo comparatorParticipants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
Receives: Drug: Bendamustine; Drug: Rituximab; Drug: Placebo

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 first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).

    Measured: Up to 22 months

Secondary outcomes (5)

  1. Overall Response Rate

    Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC.

    Measured: Up to 22 months

  2. Nodal Response Rate

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

    Measured: Up to 22 months

  3. Complete Response Rate

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

    Measured: Up to 22 months

  4. Overall Survival

    Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.

    Measured: Up to 22 months

  5. Minimal Residual Disease Negativity Rate at Week 36

    Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation or at least 12 weeks after the last dose of rituximab or bendamustine (whichever is later) for participants receiving the final dose of rituximab after the original scheduled date. MRD negativity rate was to be assessed by an IRC.

    Measured: Up to 22 months

Timeline

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

  1. First posted11 Nov 2013 (estimated)
  2. Study start5 Feb 2014
  3. Primary completion30 May 2016
  4. Study completion16 Jun 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
Double blind
Who is masked
Participant, Investigator
Enrolment
311 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01980888
Sponsor's protocol ID
GS-US-312-0123
Other IDs
2013-003313-17
Status last verified
Sep 2017
First submitted
5 Nov 2013
Last updated
19 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, Bendamustine and Rituximab in people with Chronic Lymphocytic Leukemia, run by Gilead Sciences at 91 sites in 13 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 10 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 19 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 91 sites in United States, Australia, Spain, United Kingdom, Hungary and 8 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 Oct 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 (time frame: Up to 22 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 NCT01980888.

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 19 Nov 2018.

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