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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 (RESONATEā„¢-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 - 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.
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) - Number of participants who had experienced at least one treatment emergent AE
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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United States of America
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California
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United States of America
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Florida
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Illinois
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Massachusetts
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Michigan
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Minnesota
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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United States of America
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Texas
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Belgium
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Antwerp
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Belgium
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Brugge
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Roeselare
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Canada
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Alberta
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Germany
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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
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Auckland
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New Zealand
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Christchurch
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Sweden
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Goteborg
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Sweden
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Lund
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Sweden
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Stockholm
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Turkey
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Ankara
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Turkey
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Gaziantep
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kayseri
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United Kingdom
State/province [37] 0 0
Bournemouth
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United Kingdom
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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
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Oxford
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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/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

Summary results
Other publications