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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01744691




Registration number
NCT01744691
Ethics application status
Date submitted
3/12/2012
Date registered
7/12/2012
Date last updated
27/02/2017

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
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)
Secondary ID [1] 0 0
2012-004476-19
Secondary ID [2] 0 0
PCYC-1117-CA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia With 17p Deletion 0 0
Small Lymphocytic Lymphoma With 17p Deletion 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 - 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate
Timepoint [1] 0 0
The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months
Secondary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events (AEs)
Timepoint [1] 0 0
From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure

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)

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 2
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
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Coburg
Recruitment hospital [3] 0 0
- East Melbourne
Recruitment hospital [4] 0 0
- Fremantle
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Coburg
Recruitment postcode(s) [3] 0 0
- East Melbourne
Recruitment postcode(s) [4] 0 0
- Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
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United States of America
State/province [4] 0 0
Illinois
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United States of America
State/province [5] 0 0
Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Texas
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Belgium
State/province [14] 0 0
Antwerp
Country [15] 0 0
Belgium
State/province [15] 0 0
Brugge
Country [16] 0 0
Belgium
State/province [16] 0 0
Brussels
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Belgium
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Gent
Country [18] 0 0
Belgium
State/province [18] 0 0
Kortrijk
Country [19] 0 0
Belgium
State/province [19] 0 0
Leuven
Country [20] 0 0
Belgium
State/province [20] 0 0
Roeselare
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Germany
State/province [22] 0 0
Cologne
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Germany
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Dresden
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Germany
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Heidelberg
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Germany
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Munich
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Germany
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Ulm
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New Zealand
State/province [27] 0 0
Auckland
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New Zealand
State/province [28] 0 0
Christchurch
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Sweden
State/province [29] 0 0
Goteborg
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Sweden
State/province [30] 0 0
Lund
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Sweden
State/province [31] 0 0
Stockholm
Country [32] 0 0
Turkey
State/province [32] 0 0
Ankara
Country [33] 0 0
Turkey
State/province [33] 0 0
Gaziantep
Country [34] 0 0
Turkey
State/province [34] 0 0
Istanbul
Country [35] 0 0
Turkey
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Izmir
Country [36] 0 0
Turkey
State/province [36] 0 0
Kayseri
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Bournemouth
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Glasgow
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United Kingdom
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Leeds
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United Kingdom
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Leicester
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
State/province [45] 0 0
Oxford
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Plymouth

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
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01744691
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alvina Chu, MD
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