Spots Global Cancer Trial Database for Safety and Efficacy of Blinatumomab in Adults With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma
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Trial Identification
Brief Title: Safety and Efficacy of Blinatumomab in Adults With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma
Official Title: 20150288 A Phase 2 Open-label Study Investigating the Safety and Efficacy of Blinatumomab After Frontline R-Chemotherapy in Adult Subjects With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma (DLBCL)
Study ID: NCT03023878
Conditions
Study Description
Brief Summary: A phase 2, multicenter, open-label, single arm clinical trial in adults with newly diagnosed aggressive high-risk DLBCL.
Detailed Description: The safety profile of blinatumomab after frontline rituximab (R)-chemotherapy, consisting of either R-CHOP (14 or 21) (rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone) or R-DA-EPOCH (rituximab and dose adjusted-etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin), or R-CHOEP (rituximab and cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide), will be determined. The study will consist of a screening period of up to 14 days, a standard of care (SOC) R-chemotherapy run-in period of approximately 21 weeks, a 12 to 16 week blinatumomab treatment period, a 30-day safety follow-up visit, and a long-term follow-up period that begins after the safety follow-up visit is completed until 1 year from the first dose blinatumomab.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Chicago, Illinois, United States
Research Site, Maywood, Illinois, United States
Research Site, New Orleans, Louisiana, United States
Research Site, Baltimore, Maryland, United States
Research Site, New Brunswick, New Jersey, United States
Research Site, Oklahoma City, Oklahoma, United States
Research Site, Portland, Oregon, United States
Research Site, Greenville, South Carolina, United States
Research Site, Edmonton, Alberta, Canada
Research Site, Sault Ste. Marie, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Créteil Cedex, , France
Research Site, Paris Cedex 10, , France
Research Site, Dresden, , Germany
Research Site, Ulm, , Germany
Research Site, Sevilla, Andalucía, Spain
Research Site, Salamanca, Castilla León, Spain
Research Site, Barcelona, Cataluña, Spain
Research Site, L Hospitalet De Llobregat, Cataluña, Spain
Research Site, Valencia, Comunidad Valenciana, Spain
Research Site, A coruña, Galicia, Spain
Research Site, Madrid, , Spain
Research Site, Bristol, , United Kingdom
Research Site, Sheffield, , United Kingdom
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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