CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 95 enrolled
Drug / intervention
BI 695500 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01950273
NCT01950273Phase 1Completed
CompareCT.gov

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

Boehringer Ingelheim·interventional·Posted Sep 25, 2013·Updated Sep 5, 2018

In Brief

A Phase 1 clinical trial evaluating BI 695500 and MabThera for Lymphoma, Follicular. Completed, enrolled 95 participants across 29 sites in 13 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Follicular
CountriesAustralia, Austria, Belgium, Croatia, Czechia, France, Germany, Greece, Hungary, New Zealand, Poland, Russia, Spain
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 25, 2013
Enrollment StartSep 27, 2013
Primary CompletionDec 22, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.8 years ago

Interventions

BI 695500drug

BI695500, once a week for 4 weeks (4 administrations in total)

MabTheradrug

MabThera, once a week for 4 weeks (4 administrations in total)