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

PHASE3CompletedINTERVENTIONAL
Enrollment

269

Participants

Timeline

Start Date

December 3, 2013

Primary Completion Date

August 18, 2023

Study Completion Date

August 18, 2023

Conditions
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Interventions
DRUG

Ibrutinib

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

DRUG

Next-line ibrutinib

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

Trial Locations (88)

1023

Auckland City Hospital /ID# 1116-0588, Grafton

1200

UCL Saint-Luc /ID# 1116-0164, Woluwe-Saint-Lambert

2030

ZNA Cadix /ID# 1116-0561, Antwerp

2217

St George Hospital /ID# 1116-0654, Kogarah

3000

Universitair Ziekenhuis Leuven /ID# 1116-0559, Leuven

3065

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

3084

Austin Health /ID# 1116-0170, Heidelberg

3128

Box Hill Hospital /ID# 1116-0193, Box Hill

3168

Monash Medical Centre /ID# 1116-0556, Clayton

3204

Haematology Waikato Hospital /ID# 1116-0586, Hamilton

4102

Princess Alexandra Hospital /ID# 1116-0503, Woolloongabba

5042

Flinders Medical Centre /ID# 1116-0163, Bedford Park

6021

Wellington Blood and Cancer Centre /ID# 1116-0587, Wellington South

7000

Royal Hobart /ID# 1116-0555, Hobart

8011

Canterbury Health Labs Canterbury Disrict Health Board /ID# 1116-0589, Christchurch

9000

UZ Gent /ID# 1116-0560, Ghent

11042

Northwell Health/Long Island Jewish Hospital /ID# 1116-0350, New Hyde Park

15232

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

18009

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

20122

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

20132

Ospedale San Raffaele IRCCS /ID# 1116-0523, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda /ID# 1116-0581, Milan

21018

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

27534

Southeastern Medical Oncology Center /ID# 1116-0656, Goldsboro

28050

Hospital Universitario HM Sanchinarro /ID# 1116-0537, Madrid

28100

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

28222

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

35040

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

35128

Universita degli Studi di Padova /ID# 1116-0527, Padua

35340

Dokuz Eylul University Medical Faculty /ID# 1116-0601, Izmir

38039

Erciyes Universiitesi Tip Fakultesi /ID# 1116-0602, Kayseri

40138

Institute of Hematology Seràgnoli /ID# 1116-0580, Bologna

40207

Norton Cancer Institute - St Matthews /ID# 1116-0071, Louisville

41124

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

49102

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

60637

University of Chicago /ID# 1116-0126, Chicago

63110

Washington University-School of Medicine /ID# 1116-0221, St Louis

77030

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

78240

Oncology of San Antonio /ID# 1116-0653, San Antonio

79044

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

89052

Comprehensive Cancer Centers of Nevada /ID# 1116-0712, Henderson

91010

City of Hope /ID# 1116-0047, Duarte

91031

Shaare Zedek Medical Center /ID# 1116-0577, Jerusalem

92093

Moores Cancer Center at UC San Diego /ID# 1116-0408, La Jolla

94305

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

97227

Kaiser Permanente - Northwest /ID# 1116-0677, Portland

99362

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

100142

Beijing Cancer Hospital /ID# 1116-0670, Beijing

100191

Peking University Third Hospital /ID# 1116-0673, Beijing

210029

Jiangsu Province Hospital /ID# 1116-0671, Nanjing

310003

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

390039

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

2210001

Galilee Medical Center /ID# 1116-0578, Nahariya

3109601

Rambam Health Care Campus /ID# 1116-0576, Haifa

3339419

Bnai Zion Medical Center /ID# 1116-0573, Haifa

4941492

Rabin Medical Center /ID# 1116-0575, Haifa

6423906

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

01655

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

14642-0001

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

T2N 4N2

Tom Baker Cancer Centre /ID# 1116-0157, Calgary

T6G 1Z2

Cross Cancer Institute /ID# 1116-0018, Edmonton

613 00

Fakultni nemocnice Brno /ID# 1116-0562, Brno

500 05

Fakultni nemocnice Hradec Kralove /ID# 1116-0564, Hradec Králové

305 99

Fakultni nemocnice Plzen /ID# 1116-0566, Pilsen

D08 NHY1

St James Hospital /ID# 1116-0570, Dublin

H91 YR71

University Hospital Galway /ID# 1116-0571, Galway

00161

Università La Sapienza /ID# 1116-0583, Rome

00168

Policlinico Universitario A Gemelli /ID# 1116-0891, Rome

0622

North Shore Hospital /ID# 1116-0663, Takapuna

02-172

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

36-200

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

80-952

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

41-500

Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 1116-0591, Chorzów

93-510

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

08907

Hospital Duran i Reynals /ID# 1116-0604, L'Hospitalet de Llobregat

08035

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

08036

Hospital Clinic de Barcelona /ID# 1116-0533, Barcelona

08041

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

06560

Gazi Universitesi Tip Fakultes /ID# 1116-0608, Yenimahalle

06590

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

BH15 2JB

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

SO16 6YD

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

NG5 1PB

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

OX3 9DU

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

CF14 4XN

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

CO4 5JL

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

LS9 7TF

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

SE5 9RS

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

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Pharmacyclics LLC.

INDUSTRY

NCT01724346 - Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | Biotech Hunter | Biotech Hunter