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Chronic Lymphocytic LeukemiaPhase 3NCT01659021

Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

A Phase 3 study testing Idelalisib and Ofatumumab in people with Chronic Lymphocytic Leukemia, run by Gilead Sciences at 80 sites in 11 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 the effect of the addition of idelalisib to ofatumumab 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 and Ofatumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
261 participants
Where
80 sitesin 11 countries
Study dates
4 Dec 2012to 15 Aug 2018
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

  • Adults with previously treated recurrent CLL who have measurable lymphadenopathy
  • Require therapy for CLL
  • Have experienced CLL progression < 24 months since the completion of the last prior therapy
  • Have disease that is not refractory to ofatumumab
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Who cannot join

None listed.

Trial locations and contacts

80 sites in 11 countries.

80 sites in 11 countries

United States24 sites

  • Georgia Regents University

    Augusta, Georgia, 30912

  • Center for Cancer and Blood Disorders, PC

    Bethesda, Maryland, 20817

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Tennessee Oncology, PLLC

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • The Ohio State University Medical Center

    Columbus, Ohio, 43202

  • Kaiser Permanente of Colorado

    Denver, Colorado, 80205

  • City of Hope

    Duarte, California, 91010

  • California Cancer Associates for Research and Excellence (CCARE)

    Fresno, California, 93720

  • Saint Mary's Regional Cancer Center

    Grand Junction, Colorado, 81501

  • Upstate Oncology Associates

    Greenville, South Carolina, 29601

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Montgomery Cancer Center

    Mount Sterling, Kentucky, 40353

  • Tenessee Oncology, PLLC

    Nashville, Tennessee, 37203-1781

  • Weill Cornell Medical Center

    New York, New York, 10065

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Kaiser Permanente

    San Diego, California, 92120

  • Coastal Integrative Cancer Care

    San Luis Obispo, California, 93401

  • Washington University Medical Center

    St Louis, Missouri, 63110-1010

  • Stanford University Medical Center

    Stanford, California, 94305

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • Kaiser Permanente Vallejo Medical Center

    Vallejo, California, 94589

Other trials in United States

Australia9 sites

  • Ashford Cancer Centre Research

    Ashford, South Australia, 5035

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Saint George and Sutherland Hospitals

    Kogarah, New South Wales, 2217

  • Frankston Hospital

    Melbourne, Victoria, 3199

  • Haematology and Oncology Clinics of Australia at Mater

    Milton, Queensland, 4064

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Queen Elizabeth Hospital

    Woodville, 5011

Other trials in Australia

United Kingdom9 sites

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5ST

  • Darent Valley Hospital

    Dartford, England, DA2 8DA

  • Royal Surrey County Hospital NHS Trust

    Guildford, England, GU2 7XX

  • Saint James's University Hospital

    Leeds, LS9 7TF

  • University College London

    London, NW1 2PG

  • University College London

    London, WC1E 6BT

  • Haematology and Transplant Unit

    Manchester, England, M20 4BX

  • Norfolk and Norwich University Hospital

    Norwich, Norfolk, NR4 7UY

  • Department of Haematology, Cancer and Haematology Centre, Churchill Hospital (Oxford University Hospitals)

    Oxford, OX3 7LE

Other trials in United Kingdom

Canada8 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 2T9

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Hopital Regional De Sudbury Regional Hospital (HRSRH) - Regional Cancer Program (RCP)

    Greater Sudbury, Ontario, P3E 5J1

  • Centre Hospitalier Universitaire de Montréal

    Montreal, Quebec, H1T 2M4

  • Saskatchewan Cancer Agency

    Regina, Saskatchewan, S4T 1A5

  • Centre Hospitalier Regional de Rimouski

    Rimouski, Quebec, G5L 5T1

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9

  • Cancer Care Manitoba

    Winnipeg, R3E 0V9

Other trials in Canada

France7 sites

  • CHRU Clermont- Ferrand CHU Estaing

    Auvergne, 63000

  • Centre Hospitalier Universitaire Hôpital Avicenne

    Ile-de-france, 93009

  • Hôpital Saint Louis

    Paris, Île-de-France Region, 75010

  • Centre Hospitalier de Perpignan

    Perpignan, Languedoc-Roussillon, 66046

  • Center Hospitalier Universitaire de Bordeaux

    Pessac, Aquitaine, 33604

  • Centre Hospitalier Universitaire Purpan

    Toulouse, Midi-pyrenees, 31059

  • Centre Hospitalier Universitaire Nancy

    Vandœuvre-lès-Nancy, Limousin, Lorraine, 54511

Other trials in France

Poland6 sites

  • Szpital Specjalistyczny w Brzozowie

    Brzozów, 36-200

  • Collegium Medicum Uniwersytetu Jagiellonskiego w K

    Krakow, Lesser Poland Voivodeship, 31-501

  • Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi

    Lódz, 93-510

  • Wojewódzki Szpital Specjalistyczny im. Janusza Kor

    Słupsk, Pomeranian Voivodeship, 76-200

  • Centralny Szpital Kliniczny MSW

    Warsaw, 02-507

  • Samodzielny Publiczny Szpital Kliniczny N1 Klinika

    Wroclaw, 50-367

Other trials in Poland

Spain6 sites

  • Hospital Clínic i Provincial

    Barcelona, 08025

  • Hospital Vall d´Hebrón

    Barcelona, 08035

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Puerta de Hierro Majadahonda

    Madrid, 28222

  • Hospital Morales Meseguer

    Murcia, 30008

Other trials in Spain

Belgium4 sites

  • Ziekenhuis Netwerk Antwerpen

    Antwerp, 2060

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Universitaire Ziekenhuis Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Sweden3 sites

  • Sunderby Sjukhus

    Luleå, 971 80

  • Karolinska University Hospital Solna

    Stockholm, 171 64

  • Karolinska University Hospital Huddinge

    Stockholm, 171 76

Other trials in Sweden

Denmark2 sites

  • Aalborg Hospital

    Aalborg, 9100

  • Aarhus University Hospital

    Aarhus, 8000

Other trials in Denmark

Ireland2 sites

  • University College Cork

    Cork

  • Saint James's Hospital

    Dublin, 8

Other trials in Ireland

About this study

Official title: A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

The primary objective of this study is to evaluate the effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).

Being tested
Idelalisib, Ofatumumab
Keywords
CLL, Chronic Lymphocytic Leukemia, GS-1101, CAL-101, Ofatumumab
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 tablets administered orally twice daily

  • OfatumumabDrug

    Also called Arzerra®

    Administered intravenously

Study groups in NCT01659021
Study groupRoleWhat they receive
Idelalisib+ofatumumabExperimentalRandomized Initial Therapy (24 weeks): Idelalisib + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation. Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.
Receives: Drug: Idelalisib; Drug: Ofatumumab
OfatumumabActive comparatorRandomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Observation until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation. Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.
Receives: Drug: Ofatumumab

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) was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL. PFS was analyzed using Kaplan-Meier (KM) estimates.

    Measured: Randomization to End of Study (up to 60 months)

Secondary outcomes (5)

  1. Overall Response Rate

    Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.

    • Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate \& biopsy.
    • Partial response 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. Overall response rate was analyzed using KM estimates.

    Measured: Randomization to End of Study (up to 60 months)

  2. Lymph Node Response Rate

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

    Measured: Randomization to End of Study (up to 60 months)

  3. Overall Survival

    Overall survival was defined as the interval from randomization to death from any cause. Overall survival was analyzed using KM estimates.

    Measured: Randomization to Last Long-Term Follow-Up Visit (up to maximum of 5 years)

  4. Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation

    Progression-free survival in subgroup of participants with chromosome 17p deletion and/or TP53 mutation was analyzed using KM estimates.

    Measured: Randomization to End of Study (up to 60 months)

  5. Complete Response Rate

    Complete response rate was defined as the percentage of participants who achieve a complete response and maintain their response for at least 8 weeks (with a 1-week window).

    Measured: Randomization to End of Study (up to 60 months)

Timeline

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

  1. First posted7 Aug 2012 (estimated)
  2. Study start4 Dec 2012
  3. Primary completion15 Aug 2018
  4. Study completion15 Aug 2018

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
None (open label)
Enrolment
261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01659021
Sponsor's protocol ID
GS-US-312-0119
Other IDs
2012-001236-65
Status last verified
Aug 2019
First submitted
3 Aug 2012
Last updated
14 Aug 2019
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.

Publications

  • Jones JA, Robak T, Brown JR, Awan FT, Badoux X, Coutre S, Loscertales J, Taylor K, Vandenberghe E, Wach M, Wagner-Johnston N, Ysebaert L, Dreiling L, Dubowy R, Xing G, Flinn IW, Owen C. Efficacy and safety of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukaemia: an open-label, randomised phase 3 trial. Lancet Haematol. 2017 Mar;4(3):e114-e126. doi: 10.1016/S2352-3026(17)30019-4.

    PubMed 28257752

  • Jones J, Robak T, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 7515]. American Society of Clinical Oncology (ASCO) 52nd Annual Meeting; 2016 02 - 06 June; Chicago, IL.

  • Jones JA, Wach M, Robak T, Brown JR, Menter AR, Vanderberghe E, et al. Results of a Phase 3 Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (IDELA) in Combination with Ofatumumab (OFA) for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster 7023]. American Society of Clinical Oncology (ASCO) 51st Annual Meeting; 2015 29 May - 02 June; Chicago, IL.

  • Robak T, Jones J, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 213]. 21st Congress of the European Hematology Association (EHA); 2015 09-12 June; Copenhagen, Denmark.

  • Robak T, Wach M, Jones J, Owen C, Brown J, Menter A, et al. Results Of A Phase 3 Randomized Controlled Study Evaluating The Efficacy And Safety Of Idelalisib (Idela) In Combination With Ofatumumab (Ofa) For Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster LB598]. 20th Congress of the European Hematology Association (EHA); 2015 11-14 June; Vienna, Austria.

  • Flinn I, Kimby E, Cotter FE, Giles FJ, Janssens A, Pulczynski EJ, et al. A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster TPS7131]. American Society of Clinical Oncology (ASCO); 2013 May 31-June 4; Chicago, IL.

  • Gordon MJ, Huang J, Chan RJ, Bhargava P, Danilov AV. Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials. Br J Haematol. 2021 Feb;192(4):720-728. doi: 10.1111/bjh.16879. Epub 2020 Jun 29.

    PubMed 32599655

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Idelalisib and Ofatumumab in people with Chronic Lymphocytic Leukemia, run by Gilead Sciences at 80 sites in 11 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 0 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Australia, United Kingdom, Canada, France and 6 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 31 Mar 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: Randomization to End of Study (up to 60 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 NCT01659021, which also lists 7 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 14 Aug 2019.

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