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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01744691
Registration number
NCT01744691
Ethics application status
Date submitted
3/12/2012
Date registered
7/12/2012
Titles & IDs
Public title
A Multicenter Phase 2 Study of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion
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Scientific title
An Open-label, Single Arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With 17p Deletion (RESONATE™-17)
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Secondary ID [1]
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2012-004476-19
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Secondary ID [2]
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PCYC-1117-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 With 17p Deletion
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Small Lymphocytic Lymphoma With 17p Deletion
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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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 - Ibrutinib
Experimental: ibrutinib - All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily.
Treatment: Drugs: Ibrutinib
All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
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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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Overall Response Rate
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Assessment method [1]
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The primary objective of this study is to evaluate the efficacy of ibrutinib in terms of ORR according to an Independent Review Committee (IRC). ORR based upon IRC assessment is the proportion of responders in the all treated population. Responders were subjects who achieved partial response (PR) or better, ie, complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR, per IWCLL 2008 criteria with the clarification for treatment-related lymphocytosis.
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Timepoint [1]
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The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months
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Secondary outcome [1]
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Number of Participants With Treatment Emergent Adverse Events (AEs)
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Assessment method [1]
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Number of participants who had experienced at least one treatment emergent AE
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Timepoint [1]
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From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure
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Eligibility
Key inclusion criteria
Key
* Documentation of del (17p13.1)
* Must have relapsed or refractory CLL/SLL after receiving at least 1 prior line of systemic therapy.
* Measurable nodal disease by computed tomography (CT)
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Minimum age
18
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
* History or current evidence of Richter's transformation or prolymphocytic leukemia
* Prior hematologic stem cell transplantation <6 months from study enrollment or any ongoing GVHD
* Prior exposure to ibrutinib
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
Single group
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Other design features
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Phase
Phase 2
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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
1/01/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
1/04/2016
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Sample size
Target
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Accrual to date
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Final
145
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Recruitment in Australia
Recruitment state(s)
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- Adelaide
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- Coburg
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- East Melbourne
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- Fremantle
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- Adelaide
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- Coburg
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- East Melbourne
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- Fremantle
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Recruitment outside Australia
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United States of America
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Arizona
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Plymouth
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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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Commercial sector/industry
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Name [1]
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Janssen Research & Development, LLC
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Ethics approval
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Summary
Brief summary
An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion
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Trial website
https://clinicaltrials.gov/study/NCT01744691
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Trial related presentations / publications
O'Brien S, Jones JA, Coutre SE, Mato AR, Hillmen P, Tam C, Osterborg A, Siddiqi T, Thirman MJ, Furman RR, Ilhan O, Keating MJ, Call TG, Brown JR, Stevens-Brogan M, Li Y, Clow F, James DF, Chu AD, Hallek M, Stilgenbauer S. Ibrutinib for patients with relapsed or refractory chronic lymphocytic leukaemia with 17p deletion (RESONATE-17): a phase 2, open-label, multicentre study. Lancet Oncol. 2016 Oct;17(10):1409-1418. doi: 10.1016/S1470-2045(16)30212-1. Epub 2016 Sep 13.
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Public notes
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Contacts
Principal investigator
Name
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Alvina Chu, MD
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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
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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 are available at
https://clinicaltrials.gov/study/NCT01744691