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B-cell Chronic Lymphocytic Leukemia (CLL) With 17p DeletionPhase 2NCT02044822

Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

A Phase 2 study testing Idelalisib and Rituximab in people with B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion, run by Gilead Sciences at 56 sites in 14 countries.

Terminated

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

Official record
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Trial summary

The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Idelalisib and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
56 sitesin 14 countries
Study dates
6 Aug 2014to 17 May 2016
Phase
Phase 2
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, according to International Workshop on Chronic Lymphocytic Leukemia 2008
  • Presence of 17p deletion in CLL cells as demonstrated by fluorescence in-situ hybridization (FISH) testing
  • 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
  • History of a non-CLL malignancy except for the following:
  • the malignancy has been in remission without treatment for ≥ 5 years prior to enrollment, or
  • carcinoma in situ of the cervix, or
  • adequately treated basal or squamous cell skin cancer or other localized non-melanoma skin cancer, or
Show all 18Show fewer
  • asymptomatic prostate cancer without known metastatic disease and with no current requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥ 1 year prior to enrollment, or
  • ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, or
  • other adequately treated Stage 1 or 2 cancer currently in complete remission
  • Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
  • Ongoing liver injury
  • History of noninfectious pneumonitis
  • Ongoing inflammatory bowel disease
  • 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 enrollment
  • Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

56 sites in 14 countries.

56 sites in 14 countries

United States11 sites

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80303

  • The University of Chicago Medicine

    Chicago, Illinois, 60637

  • Duke University

    Durham, North Carolina, 27705

  • GHS Cancer Institute

    Greenville, North Carolina, 29615

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Hospital of the University of Pennsylvania, Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Compass Oncology

    Portland, Oregon, 97213

  • Willamette Valley Cancer Center and Research Institute

    Springfield, Oregon, 97477

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85710

  • Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

Czechia6 sites

  • University Hospital

    Brno

  • Faculty Hospital Hradec Kralove

    Hradec Králové, 500 05

  • Hemato-Onkologicka Klinika Fn

    Olomuc

  • Faculty hospital Ostrava

    Ostrava-Poruba, 70852

  • Faculty Hospital Kralovske Vinohrady

    Prague, 10034

  • Vseobecna Fakultim Nemocnice

    Prague, 12808

Other trials in Czechia

Poland6 sites

  • Szpital Specjalistyczny w Brzozowie

    Brzozów, 36-200

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-952

  • Malopolskie Centrum Medyczne s.c.

    Krakow, 30-510

  • Wojewodzki Szpital Specjalistyczny

    Lodz, 93-510

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

    Warsaw, 02-781

  • Samodzielny Publiczny Szpital Kliniczny

    Wroclaw, 50-367

Other trials in Poland

Australia5 sites

  • St Vincent's Hospital, Sydney

    Darlinghurst, New South Wales, 2010

  • St Vincent's Hospital, Melbourne

    Fitzroy, Victoria, 3065

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Liverpool Hospital

    Liverpool, NSW 2170

  • Icon Cancer Foundation

    South Brisbane, Queensland, 4101

Other trials in Australia

Italy5 sites

  • Institute of Hematology "L. e A. Seràgnoli"

    Bologna, 40138

  • A.O.Spedali Civili Brescia

    Brescia, 25123

  • A.O.Niguarda Ca' Granda

    Milan, 20162

  • Azienda Ospedaliero Universitaria Policlinico di Modena

    Modena, 41124

  • SCDU Medicina II ed Ematologia, A.O.U. San Luigi Gonzaga

    Orbassano, 10043

Other trials in Italy

France4 sites

  • Centre Hospitalier Universitaire Hôpital Avicenne

    Bobigny, 93009

  • CHRU de Lille, Hopital Claude Huriez

    Lille, 59037

  • Centre Hospitalier Universitaire Nancy

    Nancy, 54511

  • Hopital Pitie-Salpetriere

    Paris, 75651

Other trials in France

Spain4 sites

  • Hospital Clinic

    Barcelona, Catalonia, 08036

  • Hospital Universitario Puerta De Hierro

    Madrid, 28222

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Clinico Universitario De Valencia (Chuv)

    Valencia, 46010

Other trials in Spain

Austria3 sites

  • Innsbruck University Hospital, Inner Medicine,

    Innsbruck, A-6020

  • Univ. Klinik für Innere Medizin III LKH

    Salzburg, 5020

  • Medizinische Universität Wien, Univ. Klinik f. Innere Med. I, Abteilung für Hämatologie und Hämostaseologie

    Vienna, 1090

Other trials in Austria

Romania3 sites

  • Emergency County Clinical Hospital Brasov

    Brasov, 500326

  • Spitalul Clinic Colentina

    Bucharest, 20125

  • Institutul Regional de Oncologie Iasi

    Iași, 700348

Other trials in Romania

United Kingdom3 sites

  • Saint James's University Hospital

    Leeds, LS9 7TF

  • Royal Liverpool & Broadgreen Univ. Hospitals

    Liverpool, L7 8XP

  • University Hospital Southampton NHS Trust

    Southampton, 16

Other trials in United Kingdom

Belgium2 sites

  • AZ Sint-Jan AV Brugge-Oostende

    Bruges, 8000

  • University Hospital Leuven

    Leuven, 3000

Other trials in Belgium

Portugal2 sites

  • Centro Hospitalar De Lisboa Norte, E.P.E. - Hospital Santa Maria

    Lisbon, 1649-035

  • IPO Porto Francisco Gentil, E.P.E

    Porto, 4200-072

Other trials in Portugal

Denmark1 site

  • Aalborg University Hospital

    Aalborg, 9100

Other trials in Denmark

Hungary1 site

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

    Debrecen, 4032

Other trials in Hungary

About this study

Official title: A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion.

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 those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.

Being tested
Idelalisib, Rituximab
Keywords
Chronic Lymphocytic Leukemia, CLL
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 GS-1101, CAL-101, Zydelig®

    150 mg tablets administered orally twice daily

  • RituximabDrug

    Also called Rituxan

    375 mg/m^2 administered intravenously once weekly x 8 weeks

Study groups in NCT02044822
Study groupRoleWhat they receive
Idelalisib + rituximabExperimentalParticipants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years).
Receives: Drug: Idelalisib; Drug: Rituximab

What is being measured

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

  1. Overall Response Rate

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

Secondary outcomes (6)

  1. Duration of Response

    Duration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria, excluding lymphocytosis alone.

  2. Nodal Response Rate

    Nodal response rate was 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.

  3. Complete Response Rate

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

  4. Progression-Free Survival

    Progression-free survival (PFS) was defined as the interval from first dose of study drug 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 IRC.

  5. Overall Survival

    Overall survival was defined as the interval from the start of study treatment to death from any cause.

  6. Minimal Residual Disease Negativity Rate at Week 36

    Minimal residual disease (MRD) negativity rate was defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab.

Timeline

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

  1. First posted24 Jan 2014 (estimated)
  2. Study start6 Aug 2014
  3. Primary completion27 Apr 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02044822
Sponsor's protocol ID
GS-US-312-0133
Other IDs
2013-003314-41
Status last verified
Mar 2017
First submitted
22 Jan 2014
Last updated
19 Nov 2018
Data monitoring committee
No
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 2 study testing Idelalisib and Rituximab in people with B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion, run by Gilead Sciences at 56 sites in 14 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 6 inclusion and 18 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 56 sites in United States, Czechia, Poland, Australia, Italy and 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Overall Response Rate. 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 NCT02044822.

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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