Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT ID: NCT01724346
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
269 participants
INTERVENTIONAL
2013-12-03
2023-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chlorambucil
Participants 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).
Ibrutinib
Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily
Ibrutinib
Participants 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.
Next-line ibrutinib
Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily
Interventions
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Ibrutinib
Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily
Next-line ibrutinib
Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Informed consent for Study PCYC-1116-CA
3. Independent review committee (IRC)-confirmed disease progression (PD) in the parent study PCYC-1115-CA or closure of the parent study
Exclusion Criteria
2. Intervening chemotherapy, immunotherapy, or investigational agent specifically to treat CLL if administered before date of IRC confirmed progressive disease
3. In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an investigational drug
4. Requirement for treatment with a strong CYP3A inhibitor
5. Uncontrolled systemic infection or requirement for IV antibiotics
6. Noncompliance on the parent study(PCYC-1115-CA)
65 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Pharmacyclics LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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City of Hope /ID# 1116-0047
Duarte, California, United States
Moores Cancer Center at UC San Diego /ID# 1116-0408
La Jolla, California, United States
Stanford University/Stanford Cancer Center, Campus Drive /ID# 1116-0038
Stanford, California, United States
University of Chicago /ID# 1116-0126
Chicago, Illinois, United States
Norton Cancer Institute - St Matthews /ID# 1116-0071
Louisville, Kentucky, United States
Comprehensive Cancer Centers of Nevada /ID# 1116-0712
Henderson, Louisiana, United States
University of Massachusetts - Worcester /ID# 1116-0307
Worcester, Massachusetts, United States
Washington University-School of Medicine /ID# 1116-0221
St Louis, Missouri, United States
Northwell Health/Long Island Jewish Hospital /ID# 1116-0350
New Hyde Park, New York, United States
University of Rochester Medical Center /ID# 1116-0127
Rochester, New York, United States
Southeastern Medical Oncology Center /ID# 1116-0656
Goldsboro, North Carolina, United States
Kaiser Permanente - Northwest /ID# 1116-0677
Portland, Oregon, United States
University of Pittsburgh - UPMC (Hillman Cancer Center) /ID# 1116-0050
Pittsburgh, Pennsylvania, United States
University of Texas MD Anderson Cancer Center /ID# 1116-0032
Houston, Texas, United States
Oncology of San Antonio /ID# 1116-0653
San Antonio, Texas, United States
Providence St. Mary Regional Cancer Center /ID# 1116-0731
Walla Walla, Washington, United States
St George Hospital /ID# 1116-0654
Kogarah, New South Wales, Australia
Princess Alexandra Hospital /ID# 1116-0503
Woolloongabba, Queensland, Australia
Flinders Medical Centre /ID# 1116-0163
Bedford Park, South Australia, Australia
Royal Hobart /ID# 1116-0555
Hobart, Tasmania, Australia
Box Hill Hospital /ID# 1116-0193
Box Hill, Victoria, Australia
Monash Medical Centre /ID# 1116-0556
Clayton, Victoria, Australia
St Vincent's Hospital Melbourne /ID# 1116-0501
Fitzroy Melbourne, Victoria, Australia
Austin Health /ID# 1116-0170
Heidelberg, Victoria, Australia
ZNA Cadix /ID# 1116-0561
Antwerp, Antwerpen, Belgium
UCL Saint-Luc /ID# 1116-0164
Woluwe-Saint-Lambert, Brussels Capital, Belgium
UZ Gent /ID# 1116-0560
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 1116-0559
Leuven, Vlaams-Brabant, Belgium
Tom Baker Cancer Centre /ID# 1116-0157
Calgary, Alberta, Canada
Cross Cancer Institute /ID# 1116-0018
Edmonton, Alberta, Canada
Beijing Cancer Hospital /ID# 1116-0670
Beijing, Beijing Municipality, China
Peking University Third Hospital /ID# 1116-0673
Beijing, Beijing Municipality, China
Jiangsu Province Hospital /ID# 1116-0671
Nanjing, Jiangsu, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 1116-0675
Hangzhou, Zhejiang, China
Fakultni nemocnice Brno /ID# 1116-0562
Brno, , Czechia
Fakultni nemocnice Hradec Kralove /ID# 1116-0564
Hradec Králové, , Czechia
Fakultni nemocnice Plzen /ID# 1116-0566
Pilsen, , Czechia
St James Hospital /ID# 1116-0570
Dublin, Dublin, Ireland
University Hospital Galway /ID# 1116-0571
Galway, , Ireland
Rambam Health Care Campus /ID# 1116-0576
Haifa, H_efa, Israel
Bnai Zion Medical Center /ID# 1116-0573
Haifa, H_efa, Israel
Rabin Medical Center /ID# 1116-0575
Haifa, H_efa, Israel
Shaare Zedek Medical Center /ID# 1116-0577
Jerusalem, Jerusalem, Israel
Galilee Medical Center /ID# 1116-0578
Nahariya, Northern District, Israel
Tel Aviv Sourasky Medical Center /ID# 1116-0856
Tel Aviv, , Israel
Institute of Hematology Seràgnoli /ID# 1116-0580
Bologna, Emilia-Romagna, Italy
Ospedale San Raffaele IRCCS /ID# 1116-0523
Milan, Milano, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 1116-0581
Milan, Milano, Italy
Università La Sapienza /ID# 1116-0583
Rome, Roma, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 1116-0584
Milan, , Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 1116-0524
Modena, , Italy
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 1116-0582
Novara, , Italy
Universita degli Studi di Padova /ID# 1116-0527
Padua, , Italy
Policlinico Universitario A Gemelli /ID# 1116-0891
Rome, , Italy
Auckland City Hospital /ID# 1116-0588
Grafton, Auckland, New Zealand
North Shore Hospital /ID# 1116-0663
Takapuna, Auckland, New Zealand
Haematology Waikato Hospital /ID# 1116-0586
Hamilton, Waikato Region, New Zealand
Wellington Blood and Cancer Centre /ID# 1116-0587
Wellington South, Wellington Region, New Zealand
Canterbury Health Labs Canterbury Disrict Health Board /ID# 1116-0589
Christchurch, , New Zealand
MTZ Clinical Research Sp. z o.o. /ID# 1116-0363
Warsaw, Masovian Voivodeship, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. /ID# 1116-0592
Brzozów, Podkarpackie Voivodeship, Poland
Samodzielny Publiczny Szpital Klinczny Nr-1- Akademickie Cenrum Klinic /ID# 1116-0529
Gdansk, Pomeranian Voivodeship, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 1116-0591
Chorzów, Silesian Voivodeship, Poland
Medical Univ. of Lodz and Copernicus Memorial Hospital /ID# 1116-0531
Lodz, , Poland
State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 1116-0707
Ryazan, Ryazan Oblast, Russia
Hospital Duran i Reynals /ID# 1116-0604
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 1116-0536
Majadahonda, Madrid, Spain
Hospital Universitario Vall d'Hebron /ID# 1116-0534
Barcelona, , Spain
Hospital Clinic de Barcelona /ID# 1116-0533
Barcelona, , Spain
Hospital Santa Creu i Sant Pau /ID# 1116-0535
Barcelona, , Spain
Hospital Universitario HM Sanchinarro /ID# 1116-0537
Madrid, , Spain
Gazi Universitesi Tip Fakultes /ID# 1116-0608
Yenimahalle, Ankara, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Ibn-i Sina /ID# 1116-0606
Ankara, , Turkey (Türkiye)
Ic Hastaliklari Anabilim Dali/Ege University Medical Faculty /ID# 1116-0714
Izmir, , Turkey (Türkiye)
Dokuz Eylul University Medical Faculty /ID# 1116-0601
Izmir, , Turkey (Türkiye)
Erciyes Universiitesi Tip Fakultesi /ID# 1116-0602
Kayseri, , Turkey (Türkiye)
CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 1116-0595
Vinnytsia, Vinnytsia Oblast, Ukraine
Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 1116-0597
Cherkasy, , Ukraine
Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 1116-0594
Dnipro, , Ukraine
SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 1116-0596
Lviv, , Ukraine
University Hospitals Dorset NHS Foundation Trust /ID# 1116-0551
Poole, Dorset, United Kingdom
University Hospital Southampton NHS Foundation Trust /ID# 1116-0367
Southampton, Hampshire, United Kingdom
Nottingham University Hospitals NHS Trust /ID# 1116-0548
Nottingham, Nottinghamshire, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 1116-0668
Oxford, Oxfordshire, United Kingdom
Cardiff & Vale University Health Board /ID# 1116-0607
Cardiff, Wales, United Kingdom
East Suffolk and North Essex NHS Foundation Trust /ID# 1116-0549
Colchester, , United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 1116-0550
Leeds, , United Kingdom
King's College Hospital NHS Foundation Trust /ID# 1116-0544
London, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2012-003968-44
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PCYC-1116-CA
Identifier Type: -
Identifier Source: org_study_id
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