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Chronic Lymphocytic LeukemiaPhase 3NCT01724346

Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Phase 3 study testing Ibrutinib and Next-line ibrutinib in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Pharmacyclics LLC. at 88 sites in 16 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

An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil) Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Ibrutinib and Next-line ibrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
88 sitesin 16 countries
Study dates
3 Dec 2013to 18 Aug 2023
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Randomized in the parent study, PCYC-1115-CA
  • Informed consent for Study PCYC-1116-CA
  • Independent review committee (IRC)-confirmed disease progression (PD) in the parent study PCYC-1115-CA or closure of the parent study

Who cannot join

  • Disease progression involving the central nervous system (CNS) or transformation to another histology
  • Intervening chemotherapy, immunotherapy, or investigational agent specifically to treat CLL if administered before date of IRC confirmed progressive disease
  • In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an investigational drug
  • Requirement for treatment with a strong CYP3A inhibitor
  • Uncontrolled systemic infection or requirement for IV antibiotics
  • Noncompliance on the parent study(PCYC-1115-CA)

Trial locations and contacts

88 sites in 16 countries.

88 sites in 16 countries

United States16 sites

  • University of Chicago /ID# 1116-0126

    Chicago, Illinois, 60637

  • City of Hope /ID# 1116-0047

    Duarte, California, 91010

  • Southeastern Medical Oncology Center /ID# 1116-0656

    Goldsboro, North Carolina, 27534

  • Comprehensive Cancer Centers of Nevada /ID# 1116-0712

    Henderson, Louisiana, 89052

  • University of Texas MD Anderson Cancer Center /ID# 1116-0032

    Houston, Texas, 77030

  • Moores Cancer Center at UC San Diego /ID# 1116-0408

    La Jolla, California, 92093

  • Norton Cancer Institute - St Matthews /ID# 1116-0071

    Louisville, Kentucky, 40207

  • Northwell Health/Long Island Jewish Hospital /ID# 1116-0350

    New Hyde Park, New York, 11042

  • University of Pittsburgh - UPMC (Hillman Cancer Center) /ID# 1116-0050

    Pittsburgh, Pennsylvania, 15232

  • Kaiser Permanente - Northwest /ID# 1116-0677

    Portland, Oregon, 97227

  • University of Rochester Medical Center /ID# 1116-0127

    Rochester, New York, 14642-0001

  • Oncology of San Antonio /ID# 1116-0653

    San Antonio, Texas, 78240

  • Washington University-School of Medicine /ID# 1116-0221

    St Louis, Missouri, 63110

  • Stanford University/Stanford Cancer Center, Campus Drive /ID# 1116-0038

    Stanford, California, 94305

  • Providence St. Mary Regional Cancer Center /ID# 1116-0731

    Walla Walla, Washington, 99362

  • University of Massachusetts - Worcester /ID# 1116-0307

    Worcester, Massachusetts, 01655

Other trials in United States

Italy9 sites

  • Institute of Hematology Seràgnoli /ID# 1116-0580

    Bologna, Emilia-Romagna, 40138

  • Ospedale San Raffaele IRCCS /ID# 1116-0523

    Milan, Milano, 20132

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 1116-0581

    Milan, Milano, 20162

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 1116-0584

    Milan, 20122

  • Azienda Ospedaliero-Universitaria di Modena /ID# 1116-0524

    Modena, 41124

  • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 1116-0582

    Novara, 28100

  • Universita degli Studi di Padova /ID# 1116-0527

    Padova, 35128

  • Università La Sapienza /ID# 1116-0583

    Rome, Roma, 00161

  • Policlinico Universitario A Gemelli /ID# 1116-0891

    Rome, 00168

Other trials in Italy

Australia8 sites

  • Flinders Medical Centre /ID# 1116-0163

    Bedford Park, South Australia, 5042

  • Box Hill Hospital /ID# 1116-0193

    Box Hill, Victoria, 3128

  • Monash Medical Centre /ID# 1116-0556

    Clayton, Victoria, 3168

  • St Vincent's Hospital Melbourne /ID# 1116-0501

    Fitzroy Melbourne, Victoria, 3065

  • Austin Health /ID# 1116-0170

    Heidelberg, Victoria, 3084

  • Royal Hobart /ID# 1116-0555

    Hobart, Tasmania, 7000

  • St George Hospital /ID# 1116-0654

    Kogarah, New South Wales, 2217

  • Princess Alexandra Hospital /ID# 1116-0503

    Woolloongabba, Queensland, 4102

Other trials in Australia

United Kingdom8 sites

  • Cardiff & Vale University Health Board /ID# 1116-0607

    Cardiff, Wales, CF14 4XN

  • East Suffolk and North Essex NHS Foundation Trust /ID# 1116-0549

    Colchester, CO4 5JL

  • Leeds Teaching Hospitals NHS Trust /ID# 1116-0550

    Leeds, LS9 7TF

  • King's College Hospital NHS Foundation Trust /ID# 1116-0544

    London, SE5 9RS

  • Nottingham University Hospitals NHS Trust /ID# 1116-0548

    Nottingham, Nottinghamshire, NG5 1PB

  • Oxford University Hospitals NHS Foundation Trust /ID# 1116-0668

    Oxford, Oxfordshire, OX3 9DU

  • University Hospitals Dorset NHS Foundation Trust /ID# 1116-0551

    Poole, Dorset, BH15 2JB

  • University Hospital Southampton NHS Foundation Trust /ID# 1116-0367

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

Israel6 sites

  • Rambam Health Care Campus /ID# 1116-0576

    Haifa, H_efa, 3109601

  • Bnai Zion Medical Center /ID# 1116-0573

    Haifa, H_efa, 3339419

  • Rabin Medical Center /ID# 1116-0575

    Haifa, H_efa, 4941492

  • Shaare Zedek Medical Center /ID# 1116-0577

    Jerusalem, Jerusalem, 91031

  • Galilee Medical Center /ID# 1116-0578

    Nahariya, Northern District, 2210001

  • Tel Aviv Sourasky Medical Center /ID# 1116-0856

    Tel Aviv, 6423906

Other trials in Israel

Spain6 sites

  • Hospital Universitario Vall d'Hebron /ID# 1116-0534

    Barcelona, 08035

  • Hospital Clinic de Barcelona /ID# 1116-0533

    Barcelona, 08036

  • Hospital Santa Creu i Sant Pau /ID# 1116-0535

    Barcelona, 08041

  • Hospital Duran i Reynals /ID# 1116-0604

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario HM Sanchinarro /ID# 1116-0537

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 1116-0536

    Majadahonda, Madrid, 28222

Other trials in Spain

New Zealand5 sites

  • Canterbury Health Labs Canterbury Disrict Health Board /ID# 1116-0589

    Christchurch, 8011

  • Auckland City Hospital /ID# 1116-0588

    Grafton, Auckland, 1023

  • Haematology Waikato Hospital /ID# 1116-0586

    Hamilton, Waikato Region, 3204

  • North Shore Hospital /ID# 1116-0663

    Takapuna, Auckland, 0622

  • Wellington Blood and Cancer Centre /ID# 1116-0587

    Wellington South, Wellington Region, 6021

Other trials in New Zealand

Poland5 sites

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. /ID# 1116-0592

    Brzozów, Podkarpackie Voivodeship, 36-200

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 1116-0591

    Chorzów, Silesian Voivodeship, 41-500

  • Samodzielny Publiczny Szpital Klinczny Nr-1- Akademickie Cenrum Klinic /ID# 1116-0529

    Gdansk, Pomeranian Voivodeship, 80-952

  • Medical Univ. of Lodz and Copernicus Memorial Hospital /ID# 1116-0531

    Lodz, 93-510

  • MTZ Clinical Research Sp. z o.o. /ID# 1116-0363

    Warsaw, Masovian Voivodeship, 02-172

Other trials in Poland

Turkey (Türkiye)5 sites

  • Ankara Universitesi Tip Fakultesi Ibn-i Sina /ID# 1116-0606

    Ankara, 06590

  • Ic Hastaliklari Anabilim Dali/Ege University Medical Faculty /ID# 1116-0714

    Izmir, 35040

  • Dokuz Eylul University Medical Faculty /ID# 1116-0601

    Izmir, 35340

  • Erciyes Universiitesi Tip Fakultesi /ID# 1116-0602

    Kayseri, 38039

  • Gazi Universitesi Tip Fakultes /ID# 1116-0608

    Yenimahalle, Ankara, 06560

Other trials in Turkey (Türkiye)

Belgium4 sites

  • ZNA Cadix /ID# 1116-0561

    Antwerp, Antwerpen, 2030

  • UZ Gent /ID# 1116-0560

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Leuven /ID# 1116-0559

    Leuven, Vlaams-Brabant, 3000

  • UCL Saint-Luc /ID# 1116-0164

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

China4 sites

  • Beijing Cancer Hospital /ID# 1116-0670

    Beijing, Beijing Municipality, 100142

  • Peking University Third Hospital /ID# 1116-0673

    Beijing, Beijing Municipality, 100191

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 1116-0675

    Hangzhou, Zhejiang, 310003

  • Jiangsu Province Hospital /ID# 1116-0671

    Nanjing, Jiangsu, 210029

Other trials in China

Ukraine4 sites

  • Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 1116-0597

    Cherkasy, 18009

  • Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 1116-0594

    Dnipro, 49102

  • SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 1116-0596

    Lviv, 79044

  • CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 1116-0595

    Vinnytsia, Vinnytsia Oblast, 21018

Other trials in Ukraine

Czechia3 sites

  • Fakultni nemocnice Brno /ID# 1116-0562

    Brno, 613 00

  • Fakultni nemocnice Hradec Kralove /ID# 1116-0564

    Hradec Králové, 500 05

  • Fakultni nemocnice Plzen /ID# 1116-0566

    Pilsen, 305 99

Other trials in Czechia

Canada2 sites

  • Tom Baker Cancer Centre /ID# 1116-0157

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute /ID# 1116-0018

    Edmonton, Alberta, T6G 1Z2

Other trials in Canada

Ireland2 sites

  • St James Hospital /ID# 1116-0570

    Dublin, Dublin, D08 NHY1

  • University Hospital Galway /ID# 1116-0571

    Galway, H91 YR71

Other trials in Ireland

Russia1 site

  • State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 1116-0707

    Ryazan, Ryazan Oblast, 390039

Other trials in Russia

About this study

Official title: An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib Versus Chlorambucil)

An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil)

Being tested
Ibrutinib, Next-line ibrutinib
Keywords
CLL, SLL
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.

  • IbrutinibDrug

    Also called PCI-32765

    Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily

  • Next-line ibrutinibDrug

    Also called PCI-32765

    Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily

Study groups in NCT01724346
Study groupRoleWhat they receive
ChlorambucilExperimentalParticipants who received chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) Days 1 and 15 of 28-day cycle up to 12 cycles in Study 1115. In Study 1116, participants had the option to crossover to next-line ibrutinib 420 mg/day after disease progression (PD).
Receives: Drug: Ibrutinib
IbrutinibExperimentalParticipants who received ibrutinib 420 mg daily in Study 1115 received ibrutinib orally once daily. Participants continuing in first-line ibrutinib therapy entered Study 1116 at the ibrutinib dose tolerated in Study 1115.
Receives: Drug: Next-line ibrutinib

What is being measured

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

  1. Progression Free Survival (PFS) Based on Investigator Assessment

    PFS is defined as the time from the date of randomization to the date of disease progression determined by the investigator or date of death from any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to disease progression (PD) or death. Estimated by Kaplan-Meier method.

    Measured: Median overall follow-up of 82.7 months

Secondary outcomes (6)

  1. Progression Free Survival After Initiation of Subsequent Anticancer Therapy (PFS2)

    PFS2 is defined as the time from the date of randomization to the earliest occurrence of the following three types of events:

    • PD per investigator response assessment after initiation of the first subsequent anti-cancer therapy
    • Initiation of second subsequent anti-cancer therapy
    • Death due to any cause, regardless of administration of subsequent anticancer therapy.

    Kaplan-Meier landmark estimate of the PFS2 rate at 60 months (that is, the estimated percentage of participants with PFS2 at Month 60) is presented.

    Measured: Median overall follow-up of 82.7 months

  2. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause. Kaplan-Meier landmark estimate of the OS rate at 60 months (that is, the estimated percentage of participants with OS at Month 60) is presented.

    Measured: Median overall follow-up of 82.7 months

  3. Time to Next Treatment (TTNT)

    Time from randomization to initiation of any subsequent treatment for chronic lymphocytic leukemia (CLL).

    Measured: Median overall follow-up of 82.7 months

  4. Overall Response Rate (ORR)

    ORR is defined as the percentage of participants who achieve complete response (CR), complete response with an incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR), as determined by the investigator at or prior to initiation of subsequent antineoplastic therapy according to the International Workshop on CLL (iwCLL) 2008 criteria with the 2012 iwCLL modification stating that treatment-related lymphocytosis in the setting of improvement in other parameters was not considered as PD and the 2013 iwCLL clarification of criteria for a partial response to therapy.

    Measured: Median overall follow-up of 82.7 months

  5. Rate of Minimal Residual Disease (MRD) Negativity

    Percentage of participants who achieved MRD-negative response defined as < 1 CLL cell per 10,000 leukocytes as assessed by flow cytometry of a bone marrow aspirate and/or peripheral blood sample per central laboratory at or prior to initiation of subsequent antineoplastic therapy.

    Measured: Median overall follow-up of 82.7 months

  6. Duration of Response (DOR)

    DOR will be calculated for the participants achieving a protocol-defined response (Halleck 2008; CR, CRi, nPR, PR) per investigator assessment and is defined as time from the date of initial response including PR with lymphocytosis to the date of disease progression or the date of death from any cause, whichever occurs first.

    Measured: Median overall follow-up of 82.7 months

Timeline

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

  1. First posted9 Nov 2012 (estimated)
  2. Study start3 Dec 2013
  3. Primary completion18 Aug 2023
  4. Study completion18 Aug 2023

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01724346
Sponsor's protocol ID
PCYC-1116-CA
Other IDs
2012-003968-44
Status last verified
Aug 2024
First submitted
2 Nov 2012
Last updated
19 Sep 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.

Publications

  • Burger JA, Barr PM, Robak T, Owen C, Tedeschi A, Sarma A, Patten PEM, Grosicki S, McCarthy H, Offner F, Szafer-Glusman E, Zhou C, Szoke A, Neumayr L, Dean JP, Ghia P, Kipps TJ. Final analysis of the RESONATE-2 study: up to 10 years of follow-up of first-line ibrutinib treatment for CLL/SLL. Blood. 2025 Oct 30;146(18):2168-2176. doi: 10.1182/blood.2024028205.

    PubMed 40737596

  • Barr PM, Owen C, Robak T, Tedeschi A, Bairey O, Burger JA, Hillmen P, Dearden C, Grosicki S, McCarthy H, Li JY, Offner F, Moreno C, Jermain M, Zhou C, Hsu E, Szoke A, Kipps TJ, Ghia P. Many People With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Benefit From Ibrutinib Treatment Up To 8 Years: A Plain Language Summary. Future Oncol. 2023 Jan 9. doi: 10.2217/fon-2022-0898. Online ahead of print.

    PubMed 36617990

  • Barr PM, Owen C, Robak T, Tedeschi A, Bairey O, Burger JA, Hillmen P, Coutre SE, Dearden C, Grosicki S, McCarthy H, Li JY, Offner F, Moreno C, Zhou C, Hsu E, Szoke A, Kipps TJ, Ghia P. Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia. Blood Adv. 2022 Jun 14;6(11):3440-3450. doi: 10.1182/bloodadvances.2021006434.

    PubMed 35377947

  • Coutre SE, Byrd JC, Hillmen P, Barrientos JC, Barr PM, Devereux S, Robak T, Kipps TJ, Schuh A, Moreno C, Furman RR, Burger JA, O'Dwyer M, Ghia P, Valentino R, Chang S, Dean JP, James DF, O'Brien SM. Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies. Blood Adv. 2019 Jun 25;3(12):1799-1807. doi: 10.1182/bloodadvances.2018028761.

    PubMed 31196847

  • Barr PM, Robak T, Owen C, Tedeschi A, Bairey O, Bartlett NL, Burger JA, Hillmen P, Coutre S, Devereux S, Grosicki S, McCarthy H, Li J, Simpson D, Offner F, Moreno C, Zhou C, Styles L, James D, Kipps TJ, Ghia P. Sustained efficacy and detailed clinical follow-up of first-line ibrutinib treatment in older patients with chronic lymphocytic leukemia: extended phase 3 results from RESONATE-2. Haematologica. 2018 Sep;103(9):1502-1510. doi: 10.3324/haematol.2018.192328. Epub 2018 Jun 7.

    PubMed 29880603

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ibrutinib and Next-line ibrutinib in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Pharmacyclics LLC. at 88 sites in 16 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 3 inclusion and 6 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Italy, Australia, United Kingdom, Israel and 11 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 19 Sep 2024). 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) Based on Investigator Assessment (time frame: Median overall follow-up of 82.7 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 NCT01724346, which also lists 5 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 19 Sep 2024.

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