Spots Global Cancer Trial Database for A Study of TAK-659 in Combination With Bendamustine (+/-Rituximab), Gemcitabine, Lenalidomide, or Ibrutinib for the Treatment of Participants With Advanced Non-Hodgkin Lymphoma
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Trial Identification
Brief Title: A Study of TAK-659 in Combination With Bendamustine (+/-Rituximab), Gemcitabine, Lenalidomide, or Ibrutinib for the Treatment of Participants With Advanced Non-Hodgkin Lymphoma
Official Title: A Phase 1b, Dose Escalation Study to Determine the Recommended Phase 2 Dose of TAK-659 in Combination With Bendamustine (±Rituximab), Gemcitabine, Lenalidomide, or Ibrutinib for the Treatment of Patients With Advanced Non-Hodgkin Lymphoma After At Least 1 Prior Line of Therapy
Study ID: NCT02954406
Conditions
Study Description
Brief Summary: The purpose of this study is to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of TAK-659 when administered in combination with bendamustine, bendamustine + rituximab, gemcitabine, lenalidomide, or ibrutinib.
Detailed Description: The drug being tested in this study is called TAK-659. TAK-659 is being tested to treat people who have advanced non-Hodgkin lymphoma. This study will determine the MTD or RP2D for TAK-659 in combination with bendamustine, bendamustine + rituximab, gemcitabine, lenalidomide, and ibrutinib. The study will enroll approximately 96 participants. Participants will be assigned to one of the 5 combination cohorts: * Dose Escalation Phase Cohort A: TAK-659 + Bendamustine * Dose Escalation Phase Cohort B: TAK-659 + Bendamustine + Rituximab * Dose Escalation Phase Cohort C: TAK-659 + Gemcitabine * Dose Escalation Phase Cohort D: TAK-659 + Lenalidomide * Dose Escalation Phase Cohort E: TAK-659 + Ibrutinib This study comprises 2 phases: a dose escalation phase and a safety expansion phase. Participants in all 5 cohorts (Cohorts A-E) will participate in the dose escalation phase of the study. Approximately 12 additional participants with advanced follicular lymphoma (FL) or marginal zone lymphoma (MZL) will be added to Cohort B, in the safety expansion phase. This multi-center trial will be conducted in North America and Europe. The overall time to participate in this study is approximately 30 months. Participants will make multiple visits to the clinic and will be followed up for safety for 28 days after the last dose of study drug.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona Cancer Center, Tucson, Tucson, Arizona, United States
University of California San Diego (UCSD) - Moores Cancer Center, La Jolla, California, United States
Cedars-Sinai Medical Center (CSMC) - Samuel Oschin Comprehensive Cancer Institute, West Hollywood, California, United States
University of Louisville Kentucky James Graham Brown Cancer Center, Louisville, Kentucky, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
NYU Langone Medical Center - NYU Medical Oncology Associates, New York, New York, United States
University of North Carolina - Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
University Hospitals of Cleveland, Cleveland, Ohio, United States
West Virginia University, Morgantown, West Virginia, United States
Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada
McGill University - Jewish General Hospital, Montreal, Quebec, Canada
Contact Details
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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