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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
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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)
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Secondary ID [1]
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2012-003968-44
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Secondary ID [2]
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PCYC-1116-CA
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia
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Small Lymphocytic Lymphoma
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0
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Condition category
Condition code
Cancer
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0
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
0
0
0
0
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Leukaemia - Acute leukaemia
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Cancer
0
0
0
0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
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0
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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To monitor progression-free survival (PFS)
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Timepoint [1]
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10 years
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Primary outcome [2]
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Safety as measured by all AEs and SAEs for patients randomized to Arm B (Ibrutinib) in Study PCYC-1115-CA
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Assessment method [2]
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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
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Timepoint [2]
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10 years
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Primary outcome [3]
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Long-term follow-up and Second-line therapy monitoring
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Assessment method [3]
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To follow patients for long-term outcome
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Timepoint [3]
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10 years
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Primary outcome [4]
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Efficacy evaluation of subsequent therapy
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Assessment method [4]
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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
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Timepoint [4]
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10 years
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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
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/08/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/08/2023
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Sample size
Target
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Accrual to date
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Final
232
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
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Recruitment hospital [1]
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Site Reference ID/Investigator #654 - Kogarah
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Site Reference ID/Investigator #503 - Woolloongabba
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Site Reference ID/Investigator #163 - Bedford Park
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Site Reference ID/Investigator #715 - Frankston
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Site Reference ID/Investigator #558 - Geelong
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Site Reference ID/Investigator #170 - Heidelberg
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2217 - Kogarah
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4102 - Woolloongabba
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5042 - Bedford Park
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7000 - Hobart
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3128 - Box Hill
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3168 - Clayton
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3065 - Fitzroy
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3199 - Frankston
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3220 - Geelong
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Recruitment postcode(s) [10]
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3084 - Heidelberg
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Recruitment outside Australia
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pharmacyclics LLC.
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Janssen Research & Development, LLC
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Ethics approval
Ethics application status
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Summary
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)
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Trial website
https://clinicaltrials.gov/study/NCT01724346
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Trial related presentations / publications
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. 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Jim Dean, MD, PhD
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Address
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Pharmacyclics LLC.
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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
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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