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NCT01724346 Clinical Trial

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

Chronic Lymphocytic Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01724346
Other study ID # PCYC-1116-CA
Secondary ID 2012-003968-44
Status Completed
Phase Phase 3
First received
Last updated
Start date August 28, 2012
Est. completion date August 17, 2023

Study information
Verified date June 2023
Source Pharmacyclics LLC.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 232
Est. completion date August 17, 2023
Est. primary completion date August 17, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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.
• Ibrutinib
Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily.
• 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.
• Alternative Anticancer Treatment
Specific therapy and treatment regimen are at the Investigator's discretion.
• 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.

Locations
Country Name City State
Australia Site Reference ID/Investigator #163 Bedford Park South Australia
Australia Site Reference ID/Investigator #193 Box Hill Victoria
Australia Site Reference ID/Investigator #556 Clayton Victoria
Australia Site Reference ID/Investigator #501 Fitzroy Victoria
Australia Site Reference ID/Investigator #715 Frankston Victoria
Australia Site Reference ID/Investigator #558 Geelong Victoria
Australia Site Reference ID/Investigator #170 Heidelberg Victoria
Australia Site Reference ID/Investigator #555 Hobart Tasmania
Australia Site Reference ID/Investigator #654 Kogarah New South Wales
Australia Site Reference ID/Investigator #503 Woolloongabba Queensland
Belgium Site Reference ID/Investigator #561 Antwerpen
Belgium Site Reference ID/Investigator #628 Brugge West-Vlaanderen
Belgium Site Reference ID/Investigator #184 Brussells
Belgium Site Reference ID/Investigator #164 Bruxelles Brussells
Belgium Site Reference ID/Investigator #560 Gent Oost-Vlaanderen
Belgium Site Reference ID/Investigator #559 Leuven Vlaams Brabant
Belgium Site Reference ID/Investigator #727 Yvoir Namur
Canada Site Reference ID/Investigator #157 Calgary Alberta
Canada Site Reference ID/Investigator #018 Edmonton Alberta
China Site Reference ID/Investigator #670 Beijing
China Site Reference ID/Investigator #673 Beijing
China Site Reference ID/Investigator #674 Guangzhou Guangdong
China Site Reference ID/Investigator #675 Hangzhou Zhejiang
China Site Reference ID/Investigator #671 Nanjing Jiangsu
Czechia Site Reference ID/Investigator #562 Brno
Czechia Site Reference ID/Investigator #564 Hradec Kralove Kralovehradecky Kraj
Czechia Site Reference ID/Investigator #566 Plzen-Lochotin
Ireland Site Reference ID/Investigator #570 Dublin
Ireland Site Reference ID/Investigator #572 Dublin
Ireland Site Reference ID/Investigator #571 Galway
Israel Site Reference ID/Investigator #573 Haifa
Israel Site Reference ID/Investigator #576 Haifa
Israel Site Reference ID/Investigator #577 Jerusalem
Israel Site Reference ID/Investigator #578 Nahariya
Israel Site Reference ID/Investigator #575 Peta? Tiqwa
Israel Site Reference ID/Investigator #574 Ramat Gan
Italy Site Reference ID/Investigator #580 Bologna
Italy Site Reference ID/Investigator #523 Milano
Italy Site Reference ID/Investigator #581 Milano
Italy Site Reference ID/Investigator #584 Milano
Italy Site Reference ID/Investigator #524 Modena
Italy Site Reference ID/Investigator #582 Novara Piemonte
Italy Site Reference ID/Investigator #527 Padova Veneto
Italy Site Reference ID/Investigator #583 Roma Lazio
Italy Site Reference ID/Investigator #522 Rozzano Milano
New Zealand Site Reference ID/Investigator #588 Auckland
New Zealand Site Reference ID/Investigator #663 Auckland
New Zealand Site Reference ID/Investigator #589 Christchurch Canterbury
New Zealand Site Reference ID/Investigator #586 Hamilton Waikato
New Zealand Site Reference ID/Investigator #587 Wellington
Poland Site Reference ID/Investigator #592 Brzozowie Podkarpackie
Poland Site Reference ID/Investigator #591 Chorzow
Poland Site Reference ID/Investigator #529 Gdansk
Poland Site Reference ID/Investigator #531 Lodz
Poland Site Reference ID/Investigator #590 Lublin Lubelskie
Russian Federation Site Reference ID/Investigator #707 Ryazan
Russian Federation Site Reference ID/Investigator #304 Yaroslavl
Spain Site Reference ID/Investigator #533 Barcelona
Spain Site Reference ID/Investigator #534 Barcelona
Spain Site Reference ID/Investigator #535 Barcelona
Spain Site Reference ID/Investigator #604 Barcelona
Spain Site Reference ID/Investigator #537 Madrid
Spain Site Reference ID/Investigator #536 Majadahonda Madrid
Turkey Site Reference ID/Investigator #606 Ankara
Turkey Site Reference ID/Investigator #608 Ankara
Turkey Site Reference ID/Investigator #599 Istanbul
Turkey Site Reference ID/Investigator #601 Izmir
Turkey Site Reference ID/Investigator #714 Izmir
Turkey Site Reference ID/Investigator #602 Kayseri
Ukraine Site Reference ID/Investigator #597 Cherkasy Cherkas'ka Oblast
Ukraine Site Reference ID/Investigator #594 Dnipropetrovsk Dnipropetrovs'ka Oblast'
Ukraine Site Reference ID/Investigator #725 Kharkiv Kharkivs'ka Oblast
Ukraine Site Reference ID/Investigator #596 Lviv L'vivs'ka Oblast
Ukraine Site Reference ID/Investigator #598 Simferopol Respublika Krym
Ukraine Site Reference ID/Investigator #595 Vinnytsia Vinnyts'ka Oblast
Ukraine Site Reference ID/Investigator #724 Zhytomyr Zhytomyrs'ka Oblast'
United Kingdom Site Reference ID/Investigator #721 Birmingham
United Kingdom Site Reference ID/Investigator #551 Bournemouth Dorset
United Kingdom Site Reference ID/Investigator #607 Cardiff South Glamergon
United Kingdom Site Reference ID/Investigator #549 Colchester Essex
United Kingdom Site Reference ID/Investigator #550 Leeds Yorkshire
United Kingdom Site Reference ID/Investigator #544 London England
United Kingdom Site Reference ID/Investigator #548 Nottingham
United Kingdom Site Reference ID/Investigator #668 Oxford England
United Kingdom Site Reference ID/Investigator #367 Southampton
United States Site Reference ID/Investigator #387 Ann Arbor Michigan
United States Site Reference ID/Investigator #125 Atlanta Georgia
United States Site Reference ID/Investigator #126 Chicago Illinois
United States Site Reference ID/Investigator #734 Columbus Ohio
United States Site Reference ID/Investigator #047 Duarte California
United States Site Reference ID/Investigator #656 Goldsboro North Carolina
United States Site Reference ID/Investigator #032 Houston Texas
United States Site Reference ID/Investigator #408 La Jolla California
United States Site Reference ID/Investigator #381 Laredo Texas
United States Site Reference ID/Investigator #712 Las Vegas Nevada
United States Site Reference ID/Investigator #071 Louisville Kentucky
United States Site Reference ID/Investigator #350 New Hyde Park New York
United States Site Reference ID/Investigator #050 Pittsburgh Pennsylvania
United States Site Reference ID/Investigator #677 Portland Oregon
United States Site Reference ID/Investigator #127 Rochester New York
United States Site Reference ID/Investigator #221 Saint Louis Missouri
United States Site Reference ID/Investigator #653 San Antonio Texas
United States Site Reference ID/Investigator #720 Santa Rosa California
United States Site Reference ID/Investigator #404 Seattle Washington
United States Site Reference ID/Investigator #038 Stanford California
United States Site Reference ID/Investigator #731 Walla Walla Washington
United States Site Reference ID/Investigator #307 Worcester Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Pharmacyclics LLC. Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  China,  Czechia,  Ireland,  Israel,  Italy,  New Zealand,  Poland,  Russian Federation,  Spain,  Turkey,  Ukraine,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-free Survival (PFS) To monitor progression-free survival (PFS) 10 years
Primary 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 10 years
Primary Long-term follow-up and Second-line therapy monitoring To follow patients for long-term outcome 10 years
Primary 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 10 years
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