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
NCT ID: NCT01744691
Last Updated: 2017-02-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
145 participants
INTERVENTIONAL
2013-01-31
2016-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia
NCT01589302
A Time-Limited Approach to Treatment With Ibrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
NCT04694560
A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma
NCT01973387
A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
NCT01578707
Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia
NCT01841723
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ibrutinib
All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily.
Ibrutinib
All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ibrutinib
All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must have relapsed or refractory CLL/SLL after receiving at least 1 prior line of systemic therapy.
* Measurable nodal disease by computed tomography (CT)
Exclusion Criteria
* Prior hematologic stem cell transplantation \<6 months from study enrollment or any ongoing GVHD
* Prior exposure to ibrutinib
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Pharmacyclics LLC.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alvina Chu, MD
Role: STUDY_DIRECTOR
Pharmacyclics LLC.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix, Arizona, United States
Duarte, California, United States
Greenbrae, California, United States
La Jolla, California, United States
Stanford, California, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Hackensack, New Jersey, United States
New Hyde Park, New York, United States
New York, New York, United States
Goldsboro, North Carolina, United States
Columbus, Ohio, United States
Toldedo, Ohio, United States
Houston, Texas, United States
Adelaide, , Australia
Coburg, , Australia
East Melbourne, , Australia
Fremantle, , Australia
Antwerp, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Roeselare, , Belgium
Edmonton, Alberta, Canada
Cologne, , Germany
Dresden, , Germany
Heidelberg, , Germany
Munich, , Germany
Ulm, , Germany
Auckland, , New Zealand
Christchurch, , New Zealand
Gothenburg, , Sweden
Lund, , Sweden
Stockholm, , Sweden
Ankara, , Turkey (Türkiye)
Gaziantep, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Kayseri, , Turkey (Türkiye)
Bournemouth, , United Kingdom
Glasgow, , United Kingdom
Leeds, , United Kingdom
Leicester, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Oxford, , United Kingdom
Plymouth, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
www.pharmacyclics.com
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-004476-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PCYC-1117-CA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.