Spots Global Cancer Trial Database for Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma
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Trial Identification
Brief Title: Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma
Official Title: A Randomized, Double-blind, Parallel-arm, Phase I Study to Evaluate the Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab (MabThera) Induction Immunotherapy as a First-line Treatment in Patients With Low Tumor Burden Follicular Lymphoma
Study ID: NCT01950273
Conditions
Study Description
Brief Summary: The primary objective of the study is to assess the pharmacokinetic (PK) similarity of Boehringer Ingelheim (BI) 695500 vs. rituximab (MabThera®) in previously untreated patients with low tumor burden follicular lymphoma (LTBFL). The secondary objective of the study is to evaluate the pharmacodynamics (PD), safety, and anti-tumor activity of BI 695500 vs. rituximab (MabThera®), as well as the presence of anti-drug antibodies (ADAs).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Canberra Hospital, Canberra, Migration Data, Australia
AKH - Medical University of Vienna, Wien, , Austria
Brussels - UNIV St-Luc, Bruxelles, , Belgium
UZ Leuven, Leuven, , Belgium
Namur - HOSP Ste-Elisabeth, Namur, , Belgium
Clinical Hospital Centre Zagreb, Zagreb, , Croatia
University Hospital Brno, Brno, , Czechia
University Hospital Ostrava, Ostrava-Poruba, , Czechia
Vseobecna fakultni nemocnice V Praze, Praha 2, , Czechia
INS Bergonié, Bordeaux cedex, , France
HOP Morvan, Brest, , France
Centre Hospitalier Départemental Les Oudairies, La Roche sur Yon, , France
HOP Haut-Lévêque, Pessac, , France
Hôpital la Milétrie - CHU Poitiers, Poitiers, , France
Gesundheitszentrum Wetterau gGmbH, Bad Nauheim, , Germany
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
Haemato-Onkologie Hamburg, Hamburg, , Germany
Klinikum Kassel GmbH, Kassel, , Germany
General Hospital of Athens "G. Gennimatas", Athens, , Greece
Semmelweis University, 1st Dept. Internal Medicine, Budapest, , Hungary
Auckland Clinical Studies Ltd, Auckland, , New Zealand
Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer, Warszawa, , Poland
BHI of Omsk region - Clinical Oncology Dispensary, Omsk, , Russian Federation
St. Petersburg GUZ City Clinical Oncology Dispensary, St. Petersburg, , Russian Federation
Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Puerta del Mar, Cádiz, , Spain
Fundación Jiménez Díaz, Madrid, , Spain
Hospital Virgen del Rocío, Sevilla, , Spain
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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