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

NCT01950273 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2018-09-05

Study results available
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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

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)

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-27
Primary Completion
2015-12-22
Completion
2015-12-22

Countries

  • Australia
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • New Zealand
  • Poland
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01950273 on ClinicalTrials.gov