Lymphoma, Follicular Clinical Trial
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
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).
n/a
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