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Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

Sponsor
Pharmacyclics Switzerland GmbH (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03229200
Collaborator
(none)
500
Enrollment
91
Locations
1
Arm
121.3
Anticipated Duration (Months)
5.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.
Actual Study Start Date :
May 22, 2017
Anticipated Primary Completion Date :
Jul 2, 2027
Anticipated Study Completion Date :
Jul 2, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ibrutinib

Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.

Drug: Ibrutinib
Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.

Outcome Measures

Primary Outcome Measures

  1. The objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib for subjects who meet the selection criteria. [The duration will be 3 years and will be re-evaluated.]

    Assessment of percentage of patients rolling over from each parent study.

Secondary Outcome Measures

  1. Characterize the drug safety profile by collecting long-term safety data for ibrutinib. [Up to 3 years and will be re-evaluated.]

    Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center Burbank California United States 91505
2 City Of Hope National Medical Center Duarte California United States 91010
3 UCSD Moores Cancer Center La Jolla California United States 92093-0698
4 University of California Los Angeles (UCLA) Los Angeles California United States 90095
5 Stanford University Stanford California United States 94305
6 Emory University Atlanta Georgia United States 30322
7 Northwestern University Chicago Illinois United States 60611
8 University of Chicago Chicago Illinois United States 60637
9 Norton Medical Plaza II, 3991 Dutchmans Lane Louisville Kentucky United States 40207
10 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
11 Henry Ford Health System Detroit Michigan United States 48202
12 TRIO - Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89169-3321
13 John Theurer Cancer Center, Hackensack UMC Hackensack New Jersey United States 07601
14 San Juan Oncology Associates Farmington New Mexico United States 87401
15 Northwell Health New Hyde Park New York United States 11042
16 Memorial Sloan Kettering Cancer Center New York New York United States 10065-6007
17 Weill Cornell Medical College-New York Presbyterian Hospital New York New York United States 10065
18 University of Rochester Rochester New York United States 14642
19 Levine Cancer Institute Charlotte North Carolina United States 28204
20 University of Cincinnati Medical Center Cincinnati Ohio United States 45267
21 Cleveland Clinic Cleveland Ohio United States 44195
22 The Ohio State University Columbus Ohio United States 43210
23 Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center Columbus Ohio United States 43219
24 University of Pennsylvania Abramson Cancer Center Philadelphia Pennsylvania United States 19104
25 Vanderbilt Ingram Cancer Center Nashville Tennessee United States 37232
26 University of Texas MD Anderson Cancer Center Houston Texas United States 77030-4009
27 M.D. Anderson Cancer Centre Houston Texas United States 77030
28 University of Vermont Medical Center Burlington Vermont United States 05405
29 Swedish Cancer Institute Seattle Washington United States 98104
30 Northwest Cancer Specialists, Compass Oncology Vancouver Washington United States 09868
31 Wenatchee Valley Hospital and Clinics Wenatchee Washington United States 98801
32 Yakima Valley Memorial Hospital Yakima Washington United States 98902
33 St. George Hospital Kogarah New South Wales Australia 2217
34 Concord Repatriation General Hospital - Haematology Clinical Trials Sydney New South Wales Australia 2139
35 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
36 Flinders Medical Centre Bedford Park South Australia Australia 5067
37 Ballarat Health Services Ballarat Victoria Australia 3350
38 Eastern Health Box Hill Victoria Australia 3128
39 Monash Health-Monash Medical Centre Clayton Victoria Australia 3168
40 St Vincent Hospital Fitzroy Victoria Australia 3065
41 Peter MacCallum Cancer Centre Melbourne Victoria Australia 3000
42 QEII Health Science Centre Halifax Nova Scotia Canada B3H 2Y9
43 Princess Margaret Cancer Centre Toronto Ontario Canada M5G2M9
44 McGill University Health Center Montréal Quebec Canada H4A3J1
45 University Hospital Hradec Kralove Hradec Králové Kralovehradecky Kraj Czechia 50005
46 Hematology and Oncology Masaryk University Hospital Brno Brno Czechia 62500
47 University Hospital Pilsen Pilsen Czechia 30460
48 Charles University Hospital, Prague Prague Czechia 12808
49 CHU Hotel Dieu Nantes Loire Atlantique France 44000
50 Centre Henri Becquerel Rouen Cedex France 76038
51 Centre Hospitalier Saint Brieuc Saint-Brieuc France 22000
52 Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases, Dept of Hematology and Stem Cell Budapest Hungary 1097
53 Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico Milano Italy 20122
54 Ospedale San Raffaele IRCCS Milano Italy 20132
55 ASST Grande Ospedale Metropolitano Niguarda Milano Italy 20162
56 Azienda Ospedaliera di Padova Padova Italy 35128
57 Fondazione IRCCS Policlinico San Matteo di Pavia Pavia Italy 27100
58 Azienda Ospedaliera Città della Salute e della Scienza di Torino Torino Italy 10126
59 Azienda Sanitaria Universitaria Integrata Udine Udine Italy 33100
60 Kyungpook National University Hospital (KNUH) Daegu Korea, Republic of 41944
61 Middlemore Hospital Papatoetoe Auckland New Zealand 2025
62 North Shore Hospital Auckland New Zealand 0622
63 Szpital Specjalistyczny w Brzozowie, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku Brzozów Podkarpackie Poland 36-200
64 Klinika Hematologii i Transplantologii Gdańsk Pomorskie Poland 80-211
65 SPZOZ ZSM w Chorzowie Chorzów Silesia Poland 41-500
66 Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika Łódź Poland 93-510
67 Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko Nizhniy Novgorod Nizhegorodskaya Russian Federation 603126
68 SBI of Ryazan region "Regional Clinical Hospital" Ryazan' Ryazan Region Russian Federation 390039
69 Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medical Biological Agency Saint Petersburg Russian Federation 191024
70 Almazov National Medical Research Centre Saint Petersburg Russian Federation 197341
71 Yaroslavl Regional Clinical Hospital Yaroslavl Russian Federation 150062
72 ICO - Hospital Germans Trias I Pujol Badalona Barcelona Spain 08916
73 Hospital Universitario Puerta de Hierro Majadahonda Madrid Spain 28222
74 Hospital Vall d'Hebron Barcelona Spain 08035
75 Hospital de Sanata Creus i Sant Pau Barcelona Spain 08041
76 ICO l'Hospitalet - Hospital Duran i Reynals Barcelona Spain 08908
77 Hospital Universitario 12 de Octubre Madrid Spain 28041
78 University Hospital of Salamanca Salamanca Spain 37007
79 Sunderby hospital Luleå Norrbotten Sweden 97180
80 Södra Älvsborg Hospital Borås Borås Sweden 50182
81 China Medical University Hospital Taichung Taiwan 40447
82 National Taiwan University Hospital Taipei Taiwan 100
83 Pamukkale University Medical Faculty Denizli Pamukkale Turkey 20070
84 Ankara Universitesi Tip Fakultesi Hastanesi Ankara Turkey 06100
85 Gazi University Ankara Turkey 06500
86 VKV American Hospital Istanbul Turkey 34365
87 Dokuz Eylul University İzmir Turkey 35340
88 University Hospital of Wales Cardiff United Kingdom CF14 4XW
89 Leeds Teaching Hospitals NHS Leeds United Kingdom LS9 7TF
90 University College Hospitals NHS Foundation Trust London United Kingdom NW1 2PG
91 The Christie NHS Foundation Trust Manchester United Kingdom M20 4BX

Sponsors and Collaborators

  • Pharmacyclics Switzerland GmbH

Investigators

  • Study Director: Bernhard Hauns, MD, Pharmacyclics LLC.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pharmacyclics Switzerland GmbH
ClinicalTrials.gov Identifier:
NCT03229200
Other Study ID Numbers:
  • PCYC-1145-LT
First Posted:
Jul 25, 2017
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Leukemia, B-Cell
Graft vs Host Disease

Study Results

No Results Posted as of Apr 4, 2022