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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01724346




Registration number
NCT01724346
Ethics application status
Date submitted
2/11/2012
Date registered
9/11/2012

Titles & IDs
Public title
Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Scientific 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)
Secondary ID [1] 0 0
2012-003968-44
Secondary ID [2] 0 0
PCYC-1116-CA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Small Lymphocytic Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Post-Chlorambucil Therapy Follow-up
Treatment: Drugs - Ibrutinib
Treatment: Drugs - Second-line Ibrutinib
Treatment: Drugs - Alternative Anticancer Treatment
Treatment: Drugs - Alternative Anti-cancer 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.

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.

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.

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).


Treatment: Drugs: 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.

Treatment: Drugs: Ibrutinib
Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily.

Treatment: Drugs: 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.

Treatment: Drugs: Alternative Anticancer Treatment
Specific therapy and treatment regimen are at the Investigator's discretion.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
10 years
Primary outcome [2] 0 0
Safety as measured by all AEs and SAEs for patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA
Timepoint [2] 0 0
10 years
Primary outcome [3] 0 0
Long-term follow-up and Second-line therapy monitoring
Timepoint [3] 0 0
10 years
Primary outcome [4] 0 0
Efficacy evaluation of subsequent therapy
Timepoint [4] 0 0
10 years

Eligibility
Key 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/08/2023
Sample size
Target
Accrual to date
Final
232
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Site Reference ID/Investigator #654 - Kogarah
Recruitment hospital [2] 0 0
Site Reference ID/Investigator #503 - Woolloongabba
Recruitment hospital [3] 0 0
Site Reference ID/Investigator #163 - Bedford Park
Recruitment hospital [4] 0 0
Site Reference ID/Investigator #555 - Hobart
Recruitment hospital [5] 0 0
Site Reference ID/Investigator #193 - Box Hill
Recruitment hospital [6] 0 0
Site Reference ID/Investigator #556 - Clayton
Recruitment hospital [7] 0 0
Site Reference ID/Investigator #501 - Fitzroy
Recruitment hospital [8] 0 0
Site Reference ID/Investigator #715 - Frankston
Recruitment hospital [9] 0 0
Site Reference ID/Investigator #558 - Geelong
Recruitment hospital [10] 0 0
Site Reference ID/Investigator #170 - Heidelberg
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3199 - Frankston
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Belgium
State/province [16] 0 0
Brussells
Country [17] 0 0
Belgium
State/province [17] 0 0
Namur
Country [18] 0 0
Belgium
State/province [18] 0 0
Oost-Vlaanderen
Country [19] 0 0
Belgium
State/province [19] 0 0
Vlaams Brabant
Country [20] 0 0
Belgium
State/province [20] 0 0
West-Vlaanderen
Country [21] 0 0
Belgium
State/province [21] 0 0
Antwerpen
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
China
State/province [23] 0 0
Guangdong
Country [24] 0 0
China
State/province [24] 0 0
Jiangsu
Country [25] 0 0
China
State/province [25] 0 0
Zhejiang
Country [26] 0 0
China
State/province [26] 0 0
Beijing
Country [27] 0 0
Czechia
State/province [27] 0 0
Kralovehradecky Kraj
Country [28] 0 0
Czechia
State/province [28] 0 0
Brno
Country [29] 0 0
Czechia
State/province [29] 0 0
Plzen-Lochotin
Country [30] 0 0
Ireland
State/province [30] 0 0
Dublin
Country [31] 0 0
Ireland
State/province [31] 0 0
Galway
Country [32] 0 0
Israel
State/province [32] 0 0
Haifa
Country [33] 0 0
Israel
State/province [33] 0 0
Jerusalem
Country [34] 0 0
Israel
State/province [34] 0 0
Nahariya
Country [35] 0 0
Israel
State/province [35] 0 0
Peta? Tiqwa
Country [36] 0 0
Israel
State/province [36] 0 0
Ramat Gan
Country [37] 0 0
Italy
State/province [37] 0 0
Lazio
Country [38] 0 0
Italy
State/province [38] 0 0
Milano
Country [39] 0 0
Italy
State/province [39] 0 0
Piemonte
Country [40] 0 0
Italy
State/province [40] 0 0
Veneto
Country [41] 0 0
Italy
State/province [41] 0 0
Bologna
Country [42] 0 0
Italy
State/province [42] 0 0
Modena
Country [43] 0 0
New Zealand
State/province [43] 0 0
Canterbury
Country [44] 0 0
New Zealand
State/province [44] 0 0
Waikato
Country [45] 0 0
New Zealand
State/province [45] 0 0
Auckland
Country [46] 0 0
New Zealand
State/province [46] 0 0
Wellington
Country [47] 0 0
Poland
State/province [47] 0 0
Lubelskie
Country [48] 0 0
Poland
State/province [48] 0 0
Podkarpackie
Country [49] 0 0
Poland
State/province [49] 0 0
Chorzow
Country [50] 0 0
Poland
State/province [50] 0 0
Gdansk
Country [51] 0 0
Poland
State/province [51] 0 0
Lodz
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Ryazan
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Yaroslavl
Country [54] 0 0
Spain
State/province [54] 0 0
Madrid
Country [55] 0 0
Spain
State/province [55] 0 0
Barcelona
Country [56] 0 0
Turkey
State/province [56] 0 0
Ankara
Country [57] 0 0
Turkey
State/province [57] 0 0
Istanbul
Country [58] 0 0
Turkey
State/province [58] 0 0
Izmir
Country [59] 0 0
Turkey
State/province [59] 0 0
Kayseri
Country [60] 0 0
Ukraine
State/province [60] 0 0
Cherkas'ka Oblast
Country [61] 0 0
Ukraine
State/province [61] 0 0
Dnipropetrovs'ka Oblast'
Country [62] 0 0
Ukraine
State/province [62] 0 0
Kharkivs'ka Oblast
Country [63] 0 0
Ukraine
State/province [63] 0 0
L'vivs'ka Oblast
Country [64] 0 0
Ukraine
State/province [64] 0 0
Respublika Krym
Country [65] 0 0
Ukraine
State/province [65] 0 0
Vinnyts'ka Oblast
Country [66] 0 0
Ukraine
State/province [66] 0 0
Zhytomyrs'ka Oblast'
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Dorset
Country [68] 0 0
United Kingdom
State/province [68] 0 0
England
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Essex
Country [70] 0 0
United Kingdom
State/province [70] 0 0
South Glamergon
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Yorkshire
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Birmingham
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Nottingham
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pharmacyclics LLC.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Janssen Research & Development, LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jim Dean, MD, PhD
Address 0 0
Pharmacyclics LLC.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We share this information with FDA and other authorities for the purposes of analyzing the study but not with other researchers


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01724346