Spots Global Cancer Trial Database for Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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Trial Identification
Brief Title: Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Official Title: A Multicenter Open-Label Phase 1b/2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Lenalidomide and Rituximab in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Study ID: NCT02077166
Study Description
Brief Summary: This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for transplant.
Detailed Description: Phase 1b: In the dose escalation portion of the study, various cohorts with escalating doses of lenalidomide may be explored, using the 3+3+3 principle for dose determination. Phase 2: This will be conducted as an international, multicenter, open-label study. Eligible subjects will receive ibrutinib, lenalidomide and rituximab.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama, Birmingham, Alabama, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Cedar Sinai Medical Center, Los Angeles, California, United States
UCLA Medical Center, Los Angeles, California, United States
University of Florida, Gainesville, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Iowa, Iowa City, Iowa, United States
Tulane Medical Center, New Orleans, Louisiana, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Comprehensive Cancer Center of Nevada, Las Vegas, Nevada, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Summit Medical Group, Morristown, New Jersey, United States
Weill Cornell Medical Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
University of Cincinnati Health Barrett Center, Cincinnati, Ohio, United States
Mid-Ohio Oncology/ Hematology, Columbus, Ohio, United States
University of TN Medical Center, Knoxville, Tennessee, United States
Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
Baylor Charles Sammons Cancer Center, Dallas, Texas, United States
The University of Texas, MD Anderson Cancer Center, Houston, Texas, United States
Medical Oncology Associates, PS, Spokane, Washington, United States
Northwest Medical Specialities, PLLC, Tacoma, Washington, United States
Ziekenhuis Netwerk Antwerpen - Campus Stuivenberg, Antwerpen, , Belgium
CHU Brugmann, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
Universiaetsklinikum Ulm, Ulm, Baden-Wuerttemberg, Germany
Klinikum der Universitaet Muenchen - Campus Grosshadern, Muenchen, Bayern, Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen, III. Medizinische Klinik und Polyklinik, Muenchen, Bayern, Germany
Universitaetsklinikum Wuerzburg, Medizinische Klinik und Poliklinik II, Wuerzburg, Bayern, Germany
University Hospitals Birmingham NHS Foundation Trust, Birmingham, , United Kingdom
University Hospital of Wales, Cardiff, , United Kingdom
Northwick Park Hospital, Harrow, , United Kingdom
The Leeds Teaching Hospitals, Leeds, , United Kingdom
Kings College Hospital, London, , United Kingdom
University College London Hospitals, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
University Hospital Southampton NHS Foundation Trust, Southampton, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Contact Details
Name: Jutta K. Neuenburg, MD, PhD
Affiliation: Pharmacyclics LLC.
Role: STUDY_DIRECTOR
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