NCT01950273

Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Lymphoma, Follicular

Interventions

Type	Name	Description
DRUG	BI 695500	BI695500, once a week for 4 weeks (4 administrations in total)
DRUG	MabThera	MabThera, once a week for 4 weeks (4 administrations in total)

Timeline

• Start date: 2013-09-27
• Primary completion: 2015-12-22
• Completion: 2015-12-22
• First posted: 2013-09-25
• Last updated: 2018-09-05
• Results posted: 2018-09-05

Locations

29 sites across 13 countries: Australia, Austria, Belgium, Croatia, Czechia, France, Germany, Greece, Hungary, New Zealand, Poland, Russia, Spain