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

Primary Purpose

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Post-Chlorambucil Therapy Follow-up
Ibrutinib
Second-line Ibrutinib
Alternative Anticancer Treatment
Alternative Anti-cancer Treatment
Sponsored by
Pharmacyclics LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, SLL

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Randomized in the parent study, PCYC-1115-CA
  2. Informed consent for Study PCYC-1116-CA
  3. IRC-confirmed PD in the parent study PCYC-1115-CA or closure of the parent study

Exclusion Criteria:

  1. Disease progression involving the central nervous system (CNS) or transformation to another histology
  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)

Sites / Locations

  • Site Reference ID/Investigator #047
  • Site Reference ID/Investigator #408
  • Site Reference ID/Investigator #720
  • Site Reference ID/Investigator #038
  • Site Reference ID/Investigator #125
  • Site Reference ID/Investigator #126
  • Site Reference ID/Investigator #071
  • Site Reference ID/Investigator #307
  • Site Reference ID/Investigator #387
  • Site Reference ID/Investigator #221
  • Site Reference ID/Investigator #712
  • Site Reference ID/Investigator #350
  • Site Reference ID/Investigator #127
  • Site Reference ID/Investigator #656
  • Site Reference ID/Investigator #734
  • Site Reference ID/Investigator #677
  • Site Reference ID/Investigator #050
  • Site Reference ID/Investigator #032
  • Site Reference ID/Investigator #381
  • Site Reference ID/Investigator #653
  • Site Reference ID/Investigator #404
  • Site Reference ID/Investigator #731
  • Site Reference ID/Investigator #654
  • Site Reference ID/Investigator #503
  • Site Reference ID/Investigator #163
  • Site Reference ID/Investigator #555
  • Site Reference ID/Investigator #193
  • Site Reference ID/Investigator #556
  • Site Reference ID/Investigator #501
  • Site Reference ID/Investigator #715
  • Site Reference ID/Investigator #558
  • Site Reference ID/Investigator #170
  • Site Reference ID/Investigator #164
  • Site Reference ID/Investigator #727
  • Site Reference ID/Investigator #560
  • Site Reference ID/Investigator #559
  • Site Reference ID/Investigator #628
  • Site Reference ID/Investigator #561
  • Site Reference ID/Investigator #184
  • Site Reference ID/Investigator #157
  • Site Reference ID/Investigator #018
  • Site Reference ID/Investigator #674
  • Site Reference ID/Investigator #671
  • Site Reference ID/Investigator #675
  • Site Reference ID/Investigator #670
  • Site Reference ID/Investigator #673
  • Site Reference ID/Investigator #564
  • Site Reference ID/Investigator #562
  • Site Reference ID/Investigator #566
  • Site Reference ID/Investigator #572
  • Site Reference ID/Investigator #570
  • Site Reference ID/Investigator #571
  • Site Reference ID/Investigator #573
  • Site Reference ID/Investigator #576
  • Site Reference ID/Investigator #577
  • Site Reference ID/Investigator #578
  • Site Reference ID/Investigator #575
  • Site Reference ID/Investigator #574
  • Site Reference ID/Investigator #583
  • Site Reference ID/Investigator #522
  • Site Reference ID/Investigator #582
  • Site Reference ID/Investigator #527
  • Site Reference ID/Investigator #580
  • Site Reference ID/Investigator #584
  • Site Reference ID/Investigator #523
  • Site Reference ID/Investigator #581
  • Site Reference ID/Investigator #524
  • Site Reference ID/Investigator #589
  • Site Reference ID/Investigator #586
  • Site Reference ID/Investigator #663
  • Site Reference ID/Investigator #588
  • Site Reference ID/Investigator #587
  • Site Reference ID/Investigator #590
  • Site Reference ID/Investigator #592
  • Site Reference ID/Investigator #591
  • Site Reference ID/Investigator #529
  • Site Reference ID/Investigator #531
  • Site Reference ID/Investigator #707
  • Site Reference ID/Investigator #304
  • Site Reference ID/Investigator #536
  • Site Reference ID/Investigator #534
  • Site Reference ID/Investigator #533
  • Site Reference ID/Investigator #535
  • Site Reference ID/Investigator #604
  • Site Reference ID/Investigator #537
  • Site Reference ID/Investigator #608
  • Site Reference ID/Investigator #606
  • Site Reference ID/Investigator #599
  • Site Reference ID/Investigator #714
  • Site Reference ID/Investigator #601
  • Site Reference ID/Investigator #602
  • Site Reference ID/Investigator #597
  • Site Reference ID/Investigator #594
  • Site Reference ID/Investigator #725
  • Site Reference ID/Investigator #596
  • Site Reference ID/Investigator #598
  • Site Reference ID/Investigator #595
  • Site Reference ID/Investigator #724
  • Site Reference ID/Investigator #551
  • Site Reference ID/Investigator #544
  • Site Reference ID/Investigator #668
  • Site Reference ID/Investigator #549
  • Site Reference ID/Investigator #607
  • Site Reference ID/Investigator #550
  • Site Reference ID/Investigator #721
  • Site Reference ID/Investigator #548
  • Site Reference ID/Investigator #367

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Experimental

Other

Arm Label

Arm A Post-Chlorambucil Therapy Followup

Arm B Ibrutinib

Arm C Second-line Ibrutinib

Arm D Alternative Anticancer Therapy

Arm Description

Patients randomized to Chlorambucil in the parent study(PCYC-1115-CA) who have not progressed at the time of parent study closure will be transferred to this Arm. Follow-up will continue until PD, unacceptable toxicity, or other reason for treatment discontinuation.

Patients randomized to Ibrutinib in the parent study (PCYC-1115-CA) who have not experienced PD at the time of parent study closure will be transferred to this Arm to continue on Ibrutinib treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation.

Patients who received Chlorambucil in the parent study (PCYC-1115-CA) and experienced PD are transferred to this Arm for Ibrutinib treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation.

At the Investigator's discretion, alternative anticancer treatment is a therapeutic option for patients who experienced PD during Ibrutinib treatment or during or after Chlorambucil treatment. This Arm can also be considered if drug is discontinued for other reasons (e.g., intolerability or adverse event [AE]) or prior to experiencing PD).

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
To monitor progression-free survival (PFS)
Safety as measured by all AEs and SAEs for patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA
To continue treatment and safety assessment of patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA (the parent study) who have not progressed at the time of parent study closure
Long-term follow-up and Second-line therapy monitoring
To follow patients for long-term outcome
Efficacy evaluation of subsequent therapy
To capture overall response rate (ORR), duration of response (DOR), PFS, and overall survival (OS) to subsequent therapy, and time to next therapy, in patients progressing in the parent study

Secondary Outcome Measures

Full Information

First Posted
November 2, 2012
Last Updated
September 15, 2023
Sponsor
Pharmacyclics LLC.
Collaborators
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01724346
Brief Title
Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Official Title
An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib Versus Chlorambucil)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 28, 2012 (Actual)
Primary Completion Date
August 17, 2023 (Actual)
Study Completion Date
August 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacyclics LLC.
Collaborators
Janssen Research & Development, LLC

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
An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Keywords
CLL, SLL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Masking Description
Open label study
Allocation
Non-Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A Post-Chlorambucil Therapy Followup
Arm Type
Other
Arm Description
Patients randomized to Chlorambucil in the parent study(PCYC-1115-CA) who have not progressed at the time of parent study closure will be transferred to this Arm. Follow-up will continue until PD, unacceptable toxicity, or other reason for treatment discontinuation.
Arm Title
Arm B Ibrutinib
Arm Type
Experimental
Arm Description
Patients randomized to Ibrutinib in the parent study (PCYC-1115-CA) who have not experienced PD at the time of parent study closure will be transferred to this Arm to continue on Ibrutinib treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation.
Arm Title
Arm C Second-line Ibrutinib
Arm Type
Experimental
Arm Description
Patients who received Chlorambucil in the parent study (PCYC-1115-CA) and experienced PD are transferred to this Arm for Ibrutinib treatment. Treatment will continue until PD, unacceptable toxicity, or other reasons for treatment discontinuation.
Arm Title
Arm D Alternative Anticancer Therapy
Arm Type
Other
Arm Description
At the Investigator's discretion, alternative anticancer treatment is a therapeutic option for patients who experienced PD during Ibrutinib treatment or during or after Chlorambucil treatment. This Arm can also be considered if drug is discontinued for other reasons (e.g., intolerability or adverse event [AE]) or prior to experiencing PD).
Intervention Type
Drug
Intervention Name(s)
Post-Chlorambucil Therapy Follow-up
Intervention Description
Patients remain in this Arm for continued follow-up until PD, unacceptable toxicity, or other reason for treatment discontinuation. All patients in this Arm have completed Chlorambucil therapy. Patients who have progression will exit the study.
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Other Intervention Name(s)
PCI-32765
Intervention Description
Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
Second-line Ibrutinib
Other Intervention Name(s)
PCI-32765
Intervention Description
Patients in this arm who were previously eligible to receive Second-line Ibrutinib will exit the study with option to roll-over to another long-term Ibrutinib study, if eligible.
Intervention Type
Drug
Intervention Name(s)
Alternative Anticancer Treatment
Intervention Description
Specific therapy and treatment regimen are at the Investigator's discretion.
Intervention Type
Drug
Intervention Name(s)
Alternative Anti-cancer Treatment
Intervention Description
Specific therapy and treatment regimen are at the Investigator's discretion. Patients originally randomized to Chlorambucil will exit the study. Patients originally randomized to Ibrutinib will continue on study.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
To monitor progression-free survival (PFS)
Time Frame
10 years
Title
Safety as measured by all AEs and SAEs for patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA
Description
To continue treatment and safety assessment of patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA (the parent study) who have not progressed at the time of parent study closure
Time Frame
10 years
Title
Long-term follow-up and Second-line therapy monitoring
Description
To follow patients for long-term outcome
Time Frame
10 years
Title
Efficacy evaluation of subsequent therapy
Description
To capture overall response rate (ORR), duration of response (DOR), PFS, and overall survival (OS) to subsequent therapy, and time to next therapy, in patients progressing in the parent study
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Randomized in the parent study, PCYC-1115-CA Informed consent for Study PCYC-1116-CA IRC-confirmed PD in the parent study PCYC-1115-CA or closure of the parent study Exclusion Criteria: Disease progression involving the central nervous system (CNS) or transformation to another histology Intervening chemotherapy, immunotherapy, or investigational agent specifically to treat CLL if administered before date of IRC confirmed progressive disease In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an investigational drug Requirement for treatment with a strong CYP3A inhibitor Uncontrolled systemic infection or requirement for IV antibiotics Noncompliance on the parent study(PCYC-1115-CA)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Dean, MD, PhD
Organizational Affiliation
Pharmacyclics LLC.
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator #047
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Site Reference ID/Investigator #408
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Site Reference ID/Investigator #720
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Site Reference ID/Investigator #038
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Site Reference ID/Investigator #125
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Site Reference ID/Investigator #126
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Site Reference ID/Investigator #071
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Site Reference ID/Investigator #307
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Site Reference ID/Investigator #387
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Site Reference ID/Investigator #221
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Site Reference ID/Investigator #712
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Site Reference ID/Investigator #350
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Site Reference ID/Investigator #127
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Site Reference ID/Investigator #656
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Site Reference ID/Investigator #734
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Site Reference ID/Investigator #677
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Site Reference ID/Investigator #050
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Site Reference ID/Investigator #032
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site Reference ID/Investigator #381
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Site Reference ID/Investigator #653
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site Reference ID/Investigator #404
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Site Reference ID/Investigator #731
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Site Reference ID/Investigator #654
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Site Reference ID/Investigator #503
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Site Reference ID/Investigator #163
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Site Reference ID/Investigator #555
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Site Reference ID/Investigator #193
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Site Reference ID/Investigator #556
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Site Reference ID/Investigator #501
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Site Reference ID/Investigator #715
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Site Reference ID/Investigator #558
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Site Reference ID/Investigator #170
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Site Reference ID/Investigator #164
City
Bruxelles
State/Province
Brussells
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Site Reference ID/Investigator #727
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Site Reference ID/Investigator #560
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Site Reference ID/Investigator #559
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Site Reference ID/Investigator #628
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Site Reference ID/Investigator #561
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Site Reference ID/Investigator #184
City
Brussells
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Site Reference ID/Investigator #157
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Site Reference ID/Investigator #018
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Site Reference ID/Investigator #674
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Site Reference ID/Investigator #671
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Site Reference ID/Investigator #675
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
31003
Country
China
Facility Name
Site Reference ID/Investigator #670
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Site Reference ID/Investigator #673
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Site Reference ID/Investigator #564
City
Hradec Kralove
State/Province
Kralovehradecky Kraj
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Site Reference ID/Investigator #562
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Site Reference ID/Investigator #566
City
Plzen-Lochotin
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
Site Reference ID/Investigator #572
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Site Reference ID/Investigator #570
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Site Reference ID/Investigator #571
City
Galway
ZIP/Postal Code
ST4 6QG
Country
Ireland
Facility Name
Site Reference ID/Investigator #573
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Site Reference ID/Investigator #576
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Site Reference ID/Investigator #577
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Site Reference ID/Investigator #578
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Site Reference ID/Investigator #575
City
Petaẖ Tiqwa
ZIP/Postal Code
49100
Country
Israel
Facility Name
Site Reference ID/Investigator #574
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Site Reference ID/Investigator #583
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
Site Reference ID/Investigator #522
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Site Reference ID/Investigator #582
City
Novara
State/Province
Piemonte
ZIP/Postal Code
28100
Country
Italy
Facility Name
Site Reference ID/Investigator #527
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Site Reference ID/Investigator #580
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Site Reference ID/Investigator #584
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Site Reference ID/Investigator #523
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Site Reference ID/Investigator #581
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Site Reference ID/Investigator #524
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Site Reference ID/Investigator #589
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Site Reference ID/Investigator #586
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Site Reference ID/Investigator #663
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Site Reference ID/Investigator #588
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Site Reference ID/Investigator #587
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Site Reference ID/Investigator #590
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Site Reference ID/Investigator #592
City
Brzozowie
State/Province
Podkarpackie
ZIP/Postal Code
36.200
Country
Poland
Facility Name
Site Reference ID/Investigator #591
City
Chorzow
ZIP/Postal Code
40
Country
Poland
Facility Name
Site Reference ID/Investigator #529
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Site Reference ID/Investigator #531
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Site Reference ID/Investigator #707
City
Ryazan
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
Site Reference ID/Investigator #304
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Site Reference ID/Investigator #536
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Site Reference ID/Investigator #534
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Site Reference ID/Investigator #533
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Site Reference ID/Investigator #535
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Site Reference ID/Investigator #604
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Site Reference ID/Investigator #537
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Site Reference ID/Investigator #608
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Site Reference ID/Investigator #606
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Site Reference ID/Investigator #599
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Site Reference ID/Investigator #714
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Site Reference ID/Investigator #601
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Site Reference ID/Investigator #602
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Site Reference ID/Investigator #597
City
Cherkasy
State/Province
Cherkas'ka Oblast
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Site Reference ID/Investigator #594
City
Dnipropetrovsk
State/Province
Dnipropetrovs'ka Oblast'
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Site Reference ID/Investigator #725
City
Kharkiv
State/Province
Kharkivs'ka Oblast
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Site Reference ID/Investigator #596
City
Lviv
State/Province
L'vivs'ka Oblast
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Site Reference ID/Investigator #598
City
Simferopol
State/Province
Respublika Krym
ZIP/Postal Code
95023
Country
Ukraine
Facility Name
Site Reference ID/Investigator #595
City
Vinnytsia
State/Province
Vinnyts'ka Oblast
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Site Reference ID/Investigator #724
City
Zhytomyr
State/Province
Zhytomyrs'ka Oblast'
ZIP/Postal Code
10022
Country
Ukraine
Facility Name
Site Reference ID/Investigator #551
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Site Reference ID/Investigator #544
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Site Reference ID/Investigator #668
City
Oxford
State/Province
England
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Site Reference ID/Investigator #549
City
Colchester
State/Province
Essex
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Site Reference ID/Investigator #607
City
Cardiff
State/Province
South Glamergon
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Site Reference ID/Investigator #550
City
Leeds
State/Province
Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Site Reference ID/Investigator #721
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Site Reference ID/Investigator #548
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Site Reference ID/Investigator #367
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We share this information with FDA and other authorities for the purposes of analyzing the study but not with other researchers
Citations:
PubMed Identifier
35377947
Citation
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.
Results Reference
derived
PubMed Identifier
31196847
Citation
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.
Results Reference
derived
PubMed Identifier
29880603
Citation
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.
Results Reference
derived
Links:
URL
http://www.pharmacyclics.com
Description
www.pharmacyclics.com

Learn more about this trial

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

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