A Long-term Extension Study of PCI-32765 (Ibrutinib)

Chronic Lymphocytic Leukemia Clinical Trial

— CAN3001  

Official title:

A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01804686
• Other study ID #: CR100955
• Secondary ID: 2012-004225-24PC
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: September 9, 2013
• Est. completion date: January 29, 2027

Study information

• Verified date: April 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.

Description:

This is an open-label (identity of assigned study drug will be known) study designed to collect long-term safety and efficacy data and provide ibrutinib access to participants in completed ibrutinib studies. PCI-32765 (Ibrutinib) is a first-in-class, potent, orally-administered, covalently-binding small molecule inhibitor of bruton's tyrosine kinase. "PCI-32765" and "ibrutinib" refer to the same molecule; hereafter, "ibrutinib" will be used. Participants will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study until the investigator determines that the participant is no longer benefitting from treatment (ie, disease progression or unacceptable toxicity has occurred), the participant withdraws consent, alternative access to ibrutinib is available and feasible (example, participant assistance program or commercial source of ibrutinib), or for other reasons as defined in the protocol, or until the end of the study, whichever occurs earlier. Safety will be monitored throughout the study and summarized. Efficacy may be analyzed in combination with the data collected in the parent protocol. There is no formal hypothesis testing planned for this long-term extension study. Participants for whom alternative access to ibrutinib is not available and feasible can receive treatment with single-agent ibrutinib until end of study, which is defined as the time when all participants still receiving study treatment have transitioned to commercial or alternative access to ibrutinib, have stopped receiving ibrutinib treatment, or upon a decision by the sponsor to terminate the study, whichever occurs earlier.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 700
• Est. completion date: January 29, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib
• Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks
• Agrees to protocol-defined use of effective contraception
• Negative blood or urine pregnancy test at screening

Exclusion Criteria:

• Requires anticoagulation with warfarin or equivalent vitamin K antagonists
• Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor
• Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• Chronic Graft Versus Host Disease
• Chronic Lymphocytic Leukemia
• Diffuse Large B-cell Lymphoma
• Follicular Lymphoma
• Graft vs Host Disease
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma
• Small Lymphocytic Lymphoma
• Waldenstrom Macroglobulinemia

Intervention

Drug:
• Ibrutinib
Ibrutinib will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent ibrutinib clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day.

Locations

Country	Name	City	State
Argentina	CEMIC Saavedra	Ciudad Autonoma Buenos Aires
Argentina	Fundaleu	Ciudad de Buenos Aires
Australia	Royal Adelaide Hospital	Adelaide
Australia	John Fawkner Cancer Trial Centre	Coburg
Australia	Concord Hospital	Concord
Australia	Austin Health	Heidelberg
Australia	Peter MacCallum Cancer Institute	Melbourne
Australia	Royal Perth Hospital	Perth
Australia	Alfred Hospital	Prahran
Australia	Adventist Health Care Limited trading as San Clinical Trials Unit	Wahroonga
Belgium	UZA	Antwerp
Belgium	A.Z. Sint Jan	Brugge
Belgium	UCL - Saint Luc	Brussels
Belgium	UZ Gent - departement oncologie	Gent
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	UCL Mont-Godinne	Yvoir
Brazil	Ministerio da Saude - Instituto Nacional do Cancer	Rio De Janeiro
Brazil	Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel	Salvador
Brazil	Instituto de Ensino e Pesquisa São Lucas	Sao Paulo
Canada	Jewish General Hospital	Montreal	Quebec
China	Peking University First Hospital	Beijing
China	Peking University People s Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	West China Hospital Sichuan University	Chengdu
China	Fujian Medical University	Fuzhou
China	Sun Yat-sen University Cancer Hospital	Guangzhou
China	Zhejiang University First Hospital	Hangzhou
China	Ruijin Hospital	Shanghai
China	Tangdu hospital the Fourth Military Medical	Shanxi
China	The First Affliated Hospital of Soochow University	Suzhou, Jaiangsu
China	The Institute of Hematological disease	Tianjin
China	Wuhan Union Hospital	Wuhan
Colombia	Fundacion Santa Fe	Bogota
Colombia	Fundacion Oftalmologica de Santander - FOSCAL	Floridablanca
Czechia	Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika	Brno
Czechia	Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika	Praha 10
Czechia	Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie	Praha 2
France	Hopital Henri Mondor	Creteil
France	Hôpital E. Muller	Mulhouse
France	HOPITAL SAINT LOUIS - Hematology / Oncology	Paris
France	Hôpital Necker Enfants Malades	Paris cedex 15
France	Hopital Haut Leveque Service Maladie Du Sang	Pessac
France	CH LYON SUD - Hematology	Pierre Benite
France	CHU de Tours	Tours
Germany	Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany	Berlin
Germany	Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus	Dresden
Germany	Universitätsklinikum Essen; Klinik f. Hämatologie- Germany	Essen
Germany	Justus-Liebig-Universitaet - Medizinische Klinik IV, Haematologie	Gießen
Germany	Universitätsklinikum Heidelberg Med. Klinik IV	Heidelberg
Germany	Universitätsklinikum des Saarlandes	Homburg/Saar
Germany	Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany	Magdeburg
Germany	OnkoNet Marburg GmbH	Marburg
Germany	Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany	Ulm
Greece	Laiko General Hospital - 1st department of Internal Medicine	Athens
Greece	G Papanikolaou Hospital of Thessaloniki	Thessalonikis
Hungary	Semmelweis Egyetem, I. Belgyogyaszati Klinika	Budapest N/a
Hungary	Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika	Szeged
Ireland	St James's Hospital	Dublin
Israel	Haemek Medical Center	Afula
Israel	Hillel Yaffe Medical Center - Oncology	Hadera
Israel	Rambam Health Care Campus	Haifa
Israel	Rabin Medical Center Beilinson Campus	Petah Tikva
Israel	Sheba Medical Center	Ramat-Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano
Italy	DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''	Roma
Italy	A.O.Citta della Salute e della Scienza di Torino	Torino
Japan	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital	Bunkyo-ku
Japan	Hiroshima University Hospital	Hiroshima shi
Japan	Hokkaido University Hospital	Sapporo-shi
Korea, Republic of	National Cancer Center	Goyang-Si
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Mexico	Oaxaca Site Management Organization S.C.	Oaxaca
Netherlands	VU medisch centrum - Afd.Interne - INT	Amsterdam
Poland	Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza	Brzozow
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich	Chorzów
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Pratia MCM Krakow	Krakow
Poland	Oddzial Hematologii	Opole
Poland	Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka	Slupsk
Poland	Katedra i Klinika Hematologii , Nowotworów Krwi i Transplantacji Szpiku	Wroclaw
Portugal	Instituto Portugues de Oncologia	Lisboa
Portugal	Hospital De Santa Maria	Lisbon
Portugal	Instituto Portugues de Oncologia	Porto
Puerto Rico	Auxilio Mutuo Cancer Center	San Juan
Russian Federation	Arkhangelsk Regional Clinical Hospital	Arkhangelsk
Russian Federation	Chelyabinsk Regiona Onc. Center	Chelyabinsk
Russian Federation	Emergency Hospital of Dzerzhinsk	Dzerzhinsk
Russian Federation	S.P. Botkin Moscow City Clinical Hospital	Moscow
Russian Federation	Cancer Research Center	Moscow N/a
Russian Federation	Regional Clinical Hospital n.a.Semashko	Nizhni Novgorod
Russian Federation	Medical Scientific Radiology - Center	Obninsk
Russian Federation	Perm Medical Sanitary Unit#1	Perm
Russian Federation	Republican Hospital named by V.A.Baranova	Petrozavodsk
Russian Federation	Rostov Research Institute of Oncology	Rostov-Na-Donu
Russian Federation	Ryazan Regional Clinical Hospital	Ryazan
Russian Federation	Leningrad region clinical hospital	Saint
Russian Federation	Samara Region Clinical Hospital	Samara
Russian Federation	Federal Center of Heart, Blood and Endocrinology	Sankt-Peterburg
Russian Federation	Oncological dispensary #2	Sochi
Russian Federation	City Clinical Oncology Dispensary	St. Petersburg
Russian Federation	Clinical Research Institute of Hematology and Transfusiology	St.-Petersburg
Russian Federation	Oncology Dispensary of Komi Republic	Syktyvkar
Spain	Hospital Vall d'Hebron	Barcelona N/a
Spain	Inst. Cat. Doncologia-H Duran I Reynals	L'hospitalet De Llobregat
Spain	Fundacion Jimenez Diaz	Madrid
Spain	Hosp. Gral. Univ. Gregorio Maranon	Madrid
Spain	Hosp. Univ. de La Princesa	Madrid
Spain	Hosp. Univ. Infanta Leonor	Madrid
Spain	Clinica Universitaria de Navarra	Pamplona N/a
Spain	Hospital Clinico Universitario Salamanca	Salamanca
Sweden	Sahlgrenska University hospital, Hematology Dept	Göteborg
Sweden	Skanes universitetssjukhus	Lund
Sweden	Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm	Stockholm
Taiwan	Changhua Cristian Hospital	Changhua County
Turkey	Ankara University	Ankara
Turkey	American Hospital	Istanbul
Turkey	Istanbul University	Istanbul
Turkey	Dokuz Eylul Universitesi Tip Fakultesi	Izmir
Turkey	Erciyes University	Kayseri
Ukraine	Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'	Cherkasy
Ukraine	Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center	Dnepropetrovsk
Ukraine	SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine	Kharkiv
Ukraine	Khmelnitskiy Regional Hospital, Hematology Department	Khmelnitskiy
Ukraine	State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine	Kiev
Ukraine	Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine	Lviv
Ukraine	Vinnytsya Regional Clinical Hospital named after M.I.Pirogov	Vinnitsa
United Kingdom	University Hospitals Birmingham NHS Trust,	Birmingham
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Colchester Hospital University NHS	Colchester
United Kingdom	Beatson West Of Scotland Cancer Centre	Glasgow
United Kingdom	St James's Institute of Oncology	Leeds
United Kingdom	Leicester Royal Infirmary - Haematology	Leicester
United Kingdom	King s College Hospital	London
United Kingdom	St Bartholomew's Hospital - Dept of Haematology	London
United Kingdom	University College London Hospitals NHSFT	London
United Kingdom	Christie Hospital	Manchester
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Royal Hallamshire Hospital	Sheffield
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	Royal Marsden Hospital (Sutton)	Sutton
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Battle Creek Health Systm	Battle Creek	Michigan
United States	Dana Farber Cancer Center	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University Hospital	Chicago	Illinois
United States	The Ohio State University- James Cancer Hospital	Columbus	Ohio
United States	Karmanos Cancer Institute - Wayne State University	Detroit	Michigan
United States	City of Hope Cancer Center	Duarte	California
United States	Willamette Valley Cancer Center	Eugene	Oregon
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	Indiana University	Goshen	Indiana
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	MD Anderson Cancer Center - University of Texas	Houston	Texas
United States	University of California San Diego Medical Center	La Jolla	California
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of California Los Angeles	Los Angeles	California
United States	Louisville Oncology Suburban - Norton Cancer Institute	Louisville	Kentucky
United States	University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research	Madison	Wisconsin
United States	Northwest Georgia Oncology Centers PC	Marietta	Georgia
United States	West Virginia University	Morgantown	West Virginia
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Weill Medical College of Cornell University	New York	New York
United States	Norwalk Medical Group	Norwalk	Connecticut
United States	St. Joseph Hospital Center for Cancer Prevention and Treatment	Orange	California
United States	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Kaiser Permanente	Portland	Oregon
United States	Washington University	Saint Louis	Missouri
United States	University of Washington	Seattle	Washington
United States	Avera Medical Group	Sioux Falls	South Dakota
United States	Stanford University	Stanford	California
United States	Stanford University Medical Center	Stanford	California
United States	Kansas University Medical Center	Westwood	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC	Pharmacyclics LLC.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  China,  Colombia,  Czechia,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants affected by an adverse event		Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier
Secondary	Number of participants with change in disease status		Up to the end-of-treatment visit (up to 30 days after the last dose of study medication), or until the start of a subsequent anti-caner therapy, if earlier