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Chronic Lymphocytic LeukemiaPhase 3NCT01539512

A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

A Phase 3 study testing Idelalisib and Rituximab in people with Chronic Lymphocytic Leukemia, run by Gilead Sciences at 72 sites in 5 countries.

Completed

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

Official record
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Trial summary

This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for 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 Rituximab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
72 sitesin 5 countries
Study dates
Apr 2012to Apr 2014
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

  • Adult subjects 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
  • Currently not sufficiently fit to receive cytotoxic therapy because of chemotherapy-induced bone marrow damage or comorbidities.

Who cannot join

None listed.

Trial locations and contacts

72 sites in 5 countries.

72 sites in 5 countries

United States34 sites

  • Winship Cancer Institute at Emory University

    Atlanta, Georgia, 30322

  • Collaborative Medical Research Corporation

    Boynton Beach, Florida, 33435

  • Collaborative Research Group LLC

    Boynton Beach, Florida, 33435

  • Northwestern University

    Chicago, Illinois, 60611

  • Rocky Mountain Blood and Marrow Transplant Program

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104

  • University of Florida

    Gainesville, Florida, 32610

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • University of California, San Diego- Moores Cancer Center

    La Jolla, California, 92093

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Hematology Oncology Associates of Northern New Jersey

    Morristown, New Jersey, 07962

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11042

  • Weill Cornell Medical College

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030

  • Oncology and Hematology Associates of Southwest Virginia, Inc

    Roanoke, Virginia, 24014

  • Cancer Care Network of South Texas

    San Antonio, Texas, 78217

  • UCLA

    Santa Monica, California, 90404

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109-1024

  • Willamette Valley Cancer Center

    Springfield, Oregon, 97477

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Stanford Cancer Center

    Stanford, California, 94305

  • Northwest Cancer Specialists, PC

    Tualatin, Oregon, 97062

  • Arizona Oncology Associates

    Tucson, Arizona, 85704

  • Georgetown University Medical Center Lombardi Cancer Center

    Washington D.C., District of Columbia, 20057

  • Yakima Valley Memorial Hospital / North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

United Kingdom22 sites

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • Castle Hill Hospital

    Cottingham, HU10 6ED

  • Dorset County Hospital

    Dorchester, DT1 2JY

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Northwick Park Hospital

    Harrow, HA1 3UJ

  • St James's University Hospital

    Leeds, LS9 7TF

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • King's College Hospital

    London, SE5 9RS

  • Hammersmith Hospital

    London, W12 0NN

  • Sarah Cannon Research Institute UK

    London, W1G 6AD

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Princess Royal University Hospital

    Orpington, BR6 8ND

  • Salisbury District Hospital

    Salisbury, SP2 8BJ

  • Southampton General Hospital

    Southampton, SO16 6YD

  • Royal Marsden Hospital

    Sutton, SM2 5PT

  • Great Western Hospital

    Swindon, SN3 6BB

  • Torbay District General Hospital

    Torquay, TQ2 7AA

  • Royal Cornwall Hospital

    Truro, TR1 3LJ

  • New Cross Hospital

    Wolverhampton, WV10 0QP

  • Yeovil District Hospital

    Yeovil, BA21 4AT

Other trials in United Kingdom

France7 sites

  • Hôpital Henri Mondor

    Créteil, 94010

  • Centre Hospitalier Régional Universitaire de Lille (CHRU)

    Lille, 59045

  • Hôpital Emile Muller

    Mulhouse, 68100

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hôpital Pontchaillou

    Rennes, 35019

  • Centre Henri Becquerel

    Rouen, 76038

  • Hopital Purpan

    Toulouse, 31059

Other trials in France

Germany6 sites

  • Universitätsklinikum Köln

    Cologne, 50937

  • Gemeinschaftspraxis Hämatologie-Onkologie

    Dresden, 1307

  • Internistische Gemeinschaftspraxis

    Erlangen, 91052

  • Stauferklinikum Schwäb. Gmünd

    Mutlangen, 73557

  • Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth

    Neunkirchen, 66538

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Italy3 sites

  • Ospedale Oncologico Regionale A. Businco

    Cagliari, 9121

  • Ospedale San Raffaele S.r.l.

    Milan, 20132

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

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 Rituximab for Previously Treated Chronic Lymphocytic Leukemia

This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.

Being tested
Idelalisib, Rituximab, Placebo to match idelalisib
Keywords
CLL, CAL-101, GS 1101, PI3K, GS-US-312-0117, idelalisib
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

    Idelalisib 150 mg tablet administered orally twice daily

  • RituximabDrug

    Also called Rituxan®

    Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter

  • Placebo to match idelalisibDrug

    Placebo to match idelalisib administered orally twice daily

Study groups in NCT01539512
Study groupRoleWhat they receive
Idelalisib + rituximabActive comparatorParticipants will receive idelalisib plus rituximab
Receives: Drug: Idelalisib; Drug: Rituximab
Placebo + rituximabPlacebo comparatorParticipants will receive placebo to match idelalisib plus rituximab
Receives: Drug: Rituximab; 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

    Progression-free survival 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.

    Measured: Up to 17 months

Secondary outcomes (4)

  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.

    Measured: Up to 17 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 SPD of index lymph nodes.

    Measured: Up to 17 months

  3. Overall Survival

    Overall survival was defined as the interval from randomization to death from any cause.

    Measured: Up to 17 months

  4. Complete Response Rate

    Complete response rate was defined as the percentage of participants who achieved a complete response.

    Measured: Up to 17 months

Timeline

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

  1. First posted27 Feb 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionOct 2013
  4. Study completionApr 2014

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
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01539512
Sponsor's protocol ID
GS-US-312-0116
Other IDs
2011-005180-24
Status last verified
Apr 2015
First submitted
12 Feb 2012
Last updated
14 May 2019
Data monitoring committee
Yes
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

  • Barrientos JC, Hillmen P, Salles G, Sharman J, Stilgenbauer S, Gurtovaya O, Xing G, Ruzicka B, Bhargava P, Ghia P, Pagel JM. No increased bleeding events in patients with relapsed chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma treated with idelalisib. Leuk Lymphoma. 2021 Apr;62(4):837-845. doi: 10.1080/10428194.2020.1845339. Epub 2020 Dec 10.

    PubMed 33297794

  • 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

  • Furman RR, Sharman JP, Coutre SE, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn I, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Stilgenbauer S, Cramer P, Aiello M, Johnson DM, Miller LL, Li D, Jahn TM, Dansey RD, Hallek M, O'Brien SM. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014 Mar 13;370(11):997-1007. doi: 10.1056/NEJMoa1315226. Epub 2014 Jan 22.

    PubMed 24450857

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Idelalisib and Rituximab in people with Chronic Lymphocytic Leukemia, run by Gilead Sciences at 72 sites in 5 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 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: finished, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, United Kingdom, France, Germany, Italy. 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 16 Oct 2014). 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 17 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 NCT01539512, which also lists 3 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 May 2019.

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