Clinical trial NCT01744691: 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
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia With 17p Deletion
Small Lymphocytic Lymphoma With 17p Deletion
Keywords: CLL
SLL
Lead sponsor: Pharmacyclics LLC.
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2012-12-07
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: This is a multicenter, international, open-label, single arm, Phase 2 study designed to evaluate the efficacy and safety of ibrutinib in subjects with relapsed/refractory CLL or SLL with del 17p. All subjects will receive ibrutinib until disease progression or unacceptable toxicity occurs.

Eligibility criteria: Key Inclusion Criteria:

* 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 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

Primary outcomes:
measure: Overall Response Rate
timeFrame: The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs)
timeFrame: From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Duarte
country: United States
state: California
city: Greenbrae
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Stanford
country: United States
state: California
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Hackensack
country: United States
state: New Jersey
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: Goldsboro
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Toldedo
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
city: Adelaide
country: Australia
city: Coburg
country: Australia
city: East Melbourne
country: Australia
city: Fremantle
country: Australia
city: Antwerp
country: Belgium
city: Brugge
country: Belgium
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Roeselare
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Cologne
country: Germany
city: Dresden
country: Germany
city: Heidelberg
country: Germany
city: Munich
country: Germany
city: Ulm
country: Germany
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Goteborg
country: Sweden
city: Lund
country: Sweden
city: Stockholm
country: Sweden
city: Ankara
country: Turkey
city: Gaziantep
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Kayseri
country: Turkey
city: Bournemouth
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Leeds
country: United Kingdom
city: Leicester
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Newcastle upon Tyne
country: United Kingdom
city: Oxford
country: United Kingdom
city: Plymouth
country: United Kingdom
Study officials:
affiliation: Pharmacyclics LLC.
name: Alvina Chu, MD
role: STUDY_DIRECTOR
References:
citation: 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.