Back to resultsExtended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
Primary Purpose
Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Leukemia, B-cell
Status
Enrolling by invitation
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ibrutinib
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, B-Cell
Eligibility Criteria
Inclusion Criteria:
- Subject must currently be participating in an ibrutinib clinical trial, deriving clinical benefit from treatment with ibrutinib in the opinion of the treating physician and do not have access to commercial ibrutinib within their region.
- Ongoing continuous treatment with ibrutinib.
- Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib.
- Subject has provided informed consent.
- Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control and a barrier method during the period of therapy and for 90 days after the last dose of drug.
Exclusion Criteria:
- Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment.
- Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject's participation in the protocol.
- Female subjects who are pregnant, or breastfeeding, or planning to become pregnant. Male subjects who plan to father a child while enrolled in this protocol.
Sites / Locations
- Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center
- City Of Hope National Medical Center
- UCSD Moores Cancer Center
- University of California Los Angeles (UCLA)
- Stanford University
- Emory University
- Northwestern University
- University of Chicago
- Norton Medical Plaza II, 3991 Dutchmans Lane
- Dana-Farber Cancer Institute
- Henry Ford Health System
- TRIO - Comprehensive Cancer Centers of Nevada
- John Theurer Cancer Center, Hackensack UMC
- San Juan Oncology Associates
- Northwell Health
- Memorial Sloan Kettering Cancer Center
- Weill Cornell Medical College-New York Presbyterian Hospital
- University of Rochester
- Levine Cancer Institute
- University of Cincinnati Medical Center
- Cleveland Clinic
- The Ohio State University
- Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center
- University of Pennsylvania Abramson Cancer Center
- Vanderbilt Ingram Cancer Center
- University of Texas MD Anderson Cancer Center
- M.D. Anderson Cancer Centre
- University of Vermont Medical Center
- Swedish Cancer Institute
- Northwest Cancer Specialists, Compass Oncology
- Wenatchee Valley Hospital and Clinics
- Yakima Valley Memorial Hospital
- St. George Hospital
- Concord Repatriation General Hospital - Haematology Clinical Trials
- Princess Alexandra Hospital
- Flinders Medical Centre
- Ballarat Health Services
- Eastern Health
- Monash Health-Monash Medical Centre
- St Vincent Hospital
- Peter MacCallum Cancer Centre
- QEII Health Science Centre
- Princess Margaret Cancer Centre
- McGill University Health Center
- University Hospital Hradec Kralove
- Hematology and Oncology Masaryk University Hospital Brno
- University Hospital Pilsen
- Charles University Hospital, Prague
- CHU Hotel Dieu
- Centre Henri Becquerel
- Centre Hospitalier Saint Brieuc
- Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases, Dept of Hematology and Stem Cell
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
- Ospedale San Raffaele IRCCS
- ASST Grande Ospedale Metropolitano Niguarda
- Azienda Ospedaliera di Padova
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Azienda Ospedaliera Città della Salute e della Scienza di Torino
- Azienda Sanitaria Universitaria Integrata Udine
- Kyungpook National University Hospital (KNUH)
- Middlemore Hospital
- North Shore Hospital
- Szpital Specjalistyczny w Brzozowie, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku
- Klinika Hematologii i Transplantologii
- SPZOZ ZSM w Chorzowie
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
- Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko
- SBI of Ryazan region "Regional Clinical Hospital"
- Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medical Biological Agency
- Almazov National Medical Research Centre
- Yaroslavl Regional Clinical Hospital
- ICO - Hospital Germans Trias I Pujol
- Hospital Universitario Puerta de Hierro
- Hospital Vall d'Hebron
- Hospital de Sanata Creus i Sant Pau
- ICO l'Hospitalet - Hospital Duran i Reynals
- Hospital Universitario 12 de Octubre
- University Hospital of Salamanca
- Sunderby hospital
- Södra Älvsborg Hospital Borås
- China Medical University Hospital
- National Taiwan University Hospital
- Pamukkale University Medical Faculty
- Ankara Universitesi Tip Fakultesi Hastanesi
- Gazi University
- VKV American Hospital
- Dokuz Eylul University
- University Hospital of Wales
- Leeds Teaching Hospitals NHS
- University College Hospitals NHS Foundation Trust
- The Christie NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ibrutinib
Arm Description
Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.
Outcomes
Primary Outcome Measures
The objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib for subjects who meet the selection criteria.
Assessment of percentage of patients rolling over from each parent study.
Secondary Outcome Measures
Characterize the drug safety profile by collecting long-term safety data for ibrutinib.
Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0.
Full Information
NCT ID
NCT03229200
First Posted
June 5, 2017
Last Updated
November 19, 2022
Sponsor
Pharmacyclics Switzerland GmbH
Collaborators
Janssen Biotech, Inc., including Johnson & Johnson
1. Study Identification
Unique Protocol Identification Number
NCT03229200
Brief Title
Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
Official Title
Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
July 2, 2027 (Anticipated)
Study Completion Date
July 2, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacyclics Switzerland GmbH
Collaborators
Janssen Biotech, Inc., including Johnson & Johnson
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.
Detailed Description
Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.
Subjects enrolled in this treatment protocol will receive oral continuous dosing with ibrutinib at the same dose and schedule they were receiving at the end of the respective parent study. Treatment may be continued as long as the subjects continue to derive benefit from treatment with ibrutinib until such time that ibrutinib becomes commercially available for the indication of the parent study.
Clinical evaluations (including safety assessments) will be performed per local standard of care for each disease that was studied in the parent protocol. At each visit, all ongoing and new onset non-serious AEs leading to dose reduction or discontinuation, serious adverse events (SAEs), adverse events of special interest (AESI), pregnancy events, other malignancies, and special reporting situations will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Leukemia, B-cell, Graft Vs Host Disease, Solid Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ibrutinib
Arm Type
Experimental
Arm Description
Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Intervention Description
Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.
Primary Outcome Measure Information:
Title
The objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib for subjects who meet the selection criteria.
Description
Assessment of percentage of patients rolling over from each parent study.
Time Frame
The duration will be 3 years and will be re-evaluated.
Secondary Outcome Measure Information:
Title
Characterize the drug safety profile by collecting long-term safety data for ibrutinib.
Description
Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0.
Time Frame
Up to 3 years and will be re-evaluated.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must currently be participating in an ibrutinib clinical trial, deriving clinical benefit from treatment with ibrutinib in the opinion of the treating physician and do not have access to commercial ibrutinib within their region.
Ongoing continuous treatment with ibrutinib.
Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib.
Subject has provided informed consent.
Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control and a barrier method during the period of therapy and for 90 days after the last dose of drug.
Exclusion Criteria:
Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment.
Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject's participation in the protocol.
Female subjects who are pregnant, or breastfeeding, or planning to become pregnant. Male subjects who plan to father a child while enrolled in this protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edyta Dobkowska, MD
Organizational Affiliation
Pharmacyclics LLC.
Official's Role
Study Director
Facility Information:
Facility Name
Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
City Of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Facility Name
University of California Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Norton Medical Plaza II, 3991 Dutchmans Lane
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
TRIO - Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169-3321
Country
United States
Facility Name
John Theurer Cancer Center, Hackensack UMC
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
San Juan Oncology Associates
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Facility Name
Northwell Health
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065-6007
Country
United States
Facility Name
Weill Cornell Medical College-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
University of Pennsylvania Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
M.D. Anderson Cancer Centre
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Northwest Cancer Specialists, Compass Oncology
City
Vancouver
State/Province
Washington
ZIP/Postal Code
09868
Country
United States
Facility Name
Wenatchee Valley Hospital and Clinics
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Yakima Valley Memorial Hospital
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
St. George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Concord Repatriation General Hospital - Haematology Clinical Trials
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5067
Country
Australia
Facility Name
Ballarat Health Services
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Eastern Health
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Monash Health-Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
St Vincent Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
QEII Health Science Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
McGill University Health Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada
Facility Name
University Hospital Hradec Kralove
City
Hradec Králové
State/Province
Kralovehradecky Kraj
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Hematology and Oncology Masaryk University Hospital Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
University Hospital Pilsen
City
Pilsen
ZIP/Postal Code
30460
Country
Czechia
Facility Name
Charles University Hospital, Prague
City
Prague
ZIP/Postal Code
12808
Country
Czechia
Facility Name
CHU Hotel Dieu
City
Nantes
State/Province
Loire Atlantique
ZIP/Postal Code
44000
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen Cedex
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Hospitalier Saint Brieuc
City
Saint-Brieuc
ZIP/Postal Code
22000
Country
France
Facility Name
Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases, Dept of Hematology and Stem Cell
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale San Raffaele IRCCS
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo di Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Sanitaria Universitaria Integrata Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Kyungpook National University Hospital (KNUH)
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Middlemore Hospital
City
Papatoetoe
State/Province
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
North Shore Hospital
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Szpital Specjalistyczny w Brzozowie, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku
City
Brzozów
State/Province
Podkarpackie
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Klinika Hematologii i Transplantologii
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-211
Country
Poland
Facility Name
SPZOZ ZSM w Chorzowie
City
Chorzów
State/Province
Silesia
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
City
Łódź
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko
City
Nizhniy Novgorod
State/Province
Nizhegorodskaya
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
SBI of Ryazan region "Regional Clinical Hospital"
City
Ryazan'
State/Province
Ryazan Region
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medical Biological Agency
City
Saint Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
Almazov National Medical Research Centre
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Yaroslavl Regional Clinical Hospital
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
ICO - Hospital Germans Trias I Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de Sanata Creus i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
ICO l'Hospitalet - Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
University Hospital of Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Sunderby hospital
City
Luleå
State/Province
Norrbotten
ZIP/Postal Code
97180
Country
Sweden
Facility Name
Södra Älvsborg Hospital Borås
City
Borås
ZIP/Postal Code
50182
Country
Sweden
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Pamukkale University Medical Faculty
City
Denizli
State/Province
Pamukkale
ZIP/Postal Code
20070
Country
Turkey
Facility Name
Ankara Universitesi Tip Fakultesi Hastanesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Gazi University
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
VKV American Hospital
City
Istanbul
ZIP/Postal Code
34365
Country
Turkey
Facility Name
Dokuz Eylul University
City
İzmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University College Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
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