Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Study Details
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)
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Arm A Post-Chlorambucil Therapy Followup 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. |
Drug: Post-Chlorambucil Therapy Follow-up
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.
Drug: Alternative Anticancer Treatment
Specific therapy and treatment regimen are at the Investigator's discretion.
|
Experimental: Arm B Ibrutinib 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. |
Drug: Ibrutinib
Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily.
Other Names:
Drug: Alternative Anticancer Treatment
Specific therapy and treatment regimen are at the Investigator's discretion.
|
Experimental: Arm C Second-line Ibrutinib 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. |
Drug: Second-line Ibrutinib
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.
Other Names:
Drug: Alternative Anticancer Treatment
Specific therapy and treatment regimen are at the Investigator's discretion.
|
Other: Arm D Alternative Anticancer Therapy 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). |
Drug: Alternative Anti-cancer Treatment
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.
|
Outcome Measures
Primary Outcome Measures
- Progression-free Survival (PFS) [10 years]
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 [10 years]
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 [10 years]
To follow patients for long-term outcome
- Efficacy evaluation of subsequent therapy [10 years]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Randomized in the parent study, PCYC-1115-CA
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Informed consent for Study PCYC-1116-CA
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IRC-confirmed PD in the parent study PCYC-1115-CA or closure of the parent study
Exclusion Criteria:
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Disease progression involving the central nervous system (CNS) or transformation to another histology
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Intervening chemotherapy, immunotherapy, or investigational agent specifically to treat CLL if administered before date of IRC confirmed progressive disease
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In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an investigational drug
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Requirement for treatment with a strong CYP3A inhibitor
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Uncontrolled systemic infection or requirement for IV antibiotics
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Noncompliance on the parent study(PCYC-1115-CA)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Site Reference ID/Investigator #047 | Duarte | California | United States | 91010 |
2 | Site Reference ID/Investigator #408 | La Jolla | California | United States | 92093 |
3 | Site Reference ID/Investigator #720 | Santa Rosa | California | United States | 95403 |
4 | Site Reference ID/Investigator #038 | Stanford | California | United States | 94305 |
5 | Site Reference ID/Investigator #125 | Atlanta | Georgia | United States | 30318 |
6 | Site Reference ID/Investigator #126 | Chicago | Illinois | United States | 60637 |
7 | Site Reference ID/Investigator #071 | Louisville | Kentucky | United States | 40207 |
8 | Site Reference ID/Investigator #307 | Worcester | Massachusetts | United States | 01655 |
9 | Site Reference ID/Investigator #387 | Ann Arbor | Michigan | United States | 48109 |
10 | Site Reference ID/Investigator #221 | Saint Louis | Missouri | United States | 63110 |
11 | Site Reference ID/Investigator #712 | Las Vegas | Nevada | United States | 89169 |
12 | Site Reference ID/Investigator #350 | New Hyde Park | New York | United States | 11042 |
13 | Site Reference ID/Investigator #127 | Rochester | New York | United States | 14642 |
14 | Site Reference ID/Investigator #656 | Goldsboro | North Carolina | United States | 27534 |
15 | Site Reference ID/Investigator #734 | Columbus | Ohio | United States | 43219 |
16 | Site Reference ID/Investigator #677 | Portland | Oregon | United States | 97227 |
17 | Site Reference ID/Investigator #050 | Pittsburgh | Pennsylvania | United States | 15232 |
18 | Site Reference ID/Investigator #032 | Houston | Texas | United States | 77030 |
19 | Site Reference ID/Investigator #381 | Laredo | Texas | United States | 78041 |
20 | Site Reference ID/Investigator #653 | San Antonio | Texas | United States | 78229 |
21 | Site Reference ID/Investigator #404 | Seattle | Washington | United States | 98109 |
22 | Site Reference ID/Investigator #731 | Walla Walla | Washington | United States | 99362 |
23 | Site Reference ID/Investigator #654 | Kogarah | New South Wales | Australia | 2217 |
24 | Site Reference ID/Investigator #503 | Woolloongabba | Queensland | Australia | 4102 |
25 | Site Reference ID/Investigator #163 | Bedford Park | South Australia | Australia | 5042 |
26 | Site Reference ID/Investigator #555 | Hobart | Tasmania | Australia | 7000 |
27 | Site Reference ID/Investigator #193 | Box Hill | Victoria | Australia | 3128 |
28 | Site Reference ID/Investigator #556 | Clayton | Victoria | Australia | 3168 |
29 | Site Reference ID/Investigator #501 | Fitzroy | Victoria | Australia | 3065 |
30 | Site Reference ID/Investigator #715 | Frankston | Victoria | Australia | 3199 |
31 | Site Reference ID/Investigator #558 | Geelong | Victoria | Australia | 3220 |
32 | Site Reference ID/Investigator #170 | Heidelberg | Victoria | Australia | 3084 |
33 | Site Reference ID/Investigator #164 | Bruxelles | Brussells | Belgium | 1200 |
34 | Site Reference ID/Investigator #727 | Yvoir | Namur | Belgium | 5530 |
35 | Site Reference ID/Investigator #560 | Gent | Oost-Vlaanderen | Belgium | 9000 |
36 | Site Reference ID/Investigator #559 | Leuven | Vlaams Brabant | Belgium | 3000 |
37 | Site Reference ID/Investigator #628 | Brugge | West-Vlaanderen | Belgium | 8000 |
38 | Site Reference ID/Investigator #561 | Antwerpen | Belgium | 2060 | |
39 | Site Reference ID/Investigator #184 | Brussells | Belgium | 1000 | |
40 | Site Reference ID/Investigator #157 | Calgary | Alberta | Canada | T2N 4N2 |
41 | Site Reference ID/Investigator #018 | Edmonton | Alberta | Canada | T6G 1Z2 |
42 | Site Reference ID/Investigator #674 | Guangzhou | Guangdong | China | 510060 |
43 | Site Reference ID/Investigator #671 | Nanjing | Jiangsu | China | 210029 |
44 | Site Reference ID/Investigator #675 | Hangzhou | Zhejiang | China | 31003 |
45 | Site Reference ID/Investigator #670 | Beijing | China | 100142 | |
46 | Site Reference ID/Investigator #673 | Beijing | China | 100191 | |
47 | Site Reference ID/Investigator #564 | Hradec Kralove | Kralovehradecky Kraj | Czechia | 500 05 |
48 | Site Reference ID/Investigator #562 | Brno | Czechia | 625 00 | |
49 | Site Reference ID/Investigator #566 | Plzen-Lochotin | Czechia | 304 60 | |
50 | Site Reference ID/Investigator #572 | Dublin | Ireland | 7 | |
51 | Site Reference ID/Investigator #570 | Dublin | Ireland | 8 | |
52 | Site Reference ID/Investigator #571 | Galway | Ireland | ST4 6QG | |
53 | Site Reference ID/Investigator #573 | Haifa | Israel | 31048 | |
54 | Site Reference ID/Investigator #576 | Haifa | Israel | 31096 | |
55 | Site Reference ID/Investigator #577 | Jerusalem | Israel | 91031 | |
56 | Site Reference ID/Investigator #578 | Nahariya | Israel | 22100 | |
57 | Site Reference ID/Investigator #575 | Petaẖ Tiqwa | Israel | 49100 | |
58 | Site Reference ID/Investigator #574 | Ramat Gan | Israel | 52621 | |
59 | Site Reference ID/Investigator #583 | Roma | Lazio | Italy | 00161 |
60 | Site Reference ID/Investigator #522 | Rozzano | Milano | Italy | 20089 |
61 | Site Reference ID/Investigator #582 | Novara | Piemonte | Italy | 28100 |
62 | Site Reference ID/Investigator #527 | Padova | Veneto | Italy | 35128 |
63 | Site Reference ID/Investigator #580 | Bologna | Italy | 40138 | |
64 | Site Reference ID/Investigator #584 | Milano | Italy | 20122 | |
65 | Site Reference ID/Investigator #523 | Milano | Italy | 20132 | |
66 | Site Reference ID/Investigator #581 | Milano | Italy | 20162 | |
67 | Site Reference ID/Investigator #524 | Modena | Italy | 41100 | |
68 | Site Reference ID/Investigator #589 | Christchurch | Canterbury | New Zealand | 8011 |
69 | Site Reference ID/Investigator #586 | Hamilton | Waikato | New Zealand | 3240 |
70 | Site Reference ID/Investigator #663 | Auckland | New Zealand | 0622 | |
71 | Site Reference ID/Investigator #588 | Auckland | New Zealand | 1023 | |
72 | Site Reference ID/Investigator #587 | Wellington | New Zealand | 6021 | |
73 | Site Reference ID/Investigator #590 | Lublin | Lubelskie | Poland | 20-081 |
74 | Site Reference ID/Investigator #592 | Brzozowie | Podkarpackie | Poland | 36.200 |
75 | Site Reference ID/Investigator #591 | Chorzow | Poland | 40 | |
76 | Site Reference ID/Investigator #529 | Gdansk | Poland | 80-952 | |
77 | Site Reference ID/Investigator #531 | Lodz | Poland | 93-510 | |
78 | Site Reference ID/Investigator #707 | Ryazan | Russian Federation | 390039 | |
79 | Site Reference ID/Investigator #304 | Yaroslavl | Russian Federation | 150062 | |
80 | Site Reference ID/Investigator #536 | Majadahonda | Madrid | Spain | 28222 |
81 | Site Reference ID/Investigator #534 | Barcelona | Spain | 08035 | |
82 | Site Reference ID/Investigator #533 | Barcelona | Spain | 08036 | |
83 | Site Reference ID/Investigator #535 | Barcelona | Spain | 08041 | |
84 | Site Reference ID/Investigator #604 | Barcelona | Spain | 08908 | |
85 | Site Reference ID/Investigator #537 | Madrid | Spain | 28050 | |
86 | Site Reference ID/Investigator #608 | Ankara | Turkey | 06500 | |
87 | Site Reference ID/Investigator #606 | Ankara | Turkey | 06590 | |
88 | Site Reference ID/Investigator #599 | Istanbul | Turkey | 34390 | |
89 | Site Reference ID/Investigator #714 | Izmir | Turkey | 35040 | |
90 | Site Reference ID/Investigator #601 | Izmir | Turkey | 35340 | |
91 | Site Reference ID/Investigator #602 | Kayseri | Turkey | 38039 | |
92 | Site Reference ID/Investigator #597 | Cherkasy | Cherkas'ka Oblast | Ukraine | 18009 |
93 | Site Reference ID/Investigator #594 | Dnipropetrovsk | Dnipropetrovs'ka Oblast' | Ukraine | 49102 |
94 | Site Reference ID/Investigator #725 | Kharkiv | Kharkivs'ka Oblast | Ukraine | 61070 |
95 | Site Reference ID/Investigator #596 | Lviv | L'vivs'ka Oblast | Ukraine | 79044 |
96 | Site Reference ID/Investigator #598 | Simferopol | Respublika Krym | Ukraine | 95023 |
97 | Site Reference ID/Investigator #595 | Vinnytsia | Vinnyts'ka Oblast | Ukraine | 21018 |
98 | Site Reference ID/Investigator #724 | Zhytomyr | Zhytomyrs'ka Oblast' | Ukraine | 10022 |
99 | Site Reference ID/Investigator #551 | Bournemouth | Dorset | United Kingdom | BH7 7DW |
100 | Site Reference ID/Investigator #544 | London | England | United Kingdom | SE5 9RS |
101 | Site Reference ID/Investigator #668 | Oxford | England | United Kingdom | OX3 7LE |
102 | Site Reference ID/Investigator #549 | Colchester | Essex | United Kingdom | CO4 5JL |
103 | Site Reference ID/Investigator #607 | Cardiff | South Glamergon | United Kingdom | CF14 4XW |
104 | Site Reference ID/Investigator #550 | Leeds | Yorkshire | United Kingdom | LS9 7TF |
105 | Site Reference ID/Investigator #721 | Birmingham | United Kingdom | B9 5SS | |
106 | Site Reference ID/Investigator #548 | Nottingham | United Kingdom | NG5 1PB | |
107 | Site Reference ID/Investigator #367 | Southampton | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- Pharmacyclics LLC.
- Janssen Research & Development, LLC
Investigators
- Study Director: Jim Dean, MD, PhD, Pharmacyclics LLC.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- PCYC-1116-CA
- 2012-003968-44