BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma

Phase 3

Terminated

• Conditions: Lymphoma, Non-Hodgkin
• Interventions: Drug: BI 695500; Drug: Rituximab

• Registration Number: NCT02417129
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is a Phase III, multicenter, randomized, double-blind, parallel-arm, active comparator trial to evaluate BI 695500 versus rituximab as a first-line immunotherapy treatment in patients with LTBFL. Patients will be randomly assigned in a 1:1 ratio to receive 375 mg/m2 of BI 695500 or rituximab via intravenous (IV) infusion once a week for 4 weeks (total of 4 dosages administered on Days 1, 8, 15, and 22). Disease assessments will be performed at the End of Study (EOS) Visit at Week 30.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-04-10
• Study First Posted: 2015-04-15
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-12
• Results First Submitted: 2016-12-05
• Results First Submitted QC: 2016-12-05
• Last Update Submitted: 2016-12-05
• Results First Posted: 2017-01-30
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 695500	BI 695500	375 mg/m2; One intravenous infusion once a week for 4 weeks
Rituximab (US reference product)	Rituximab	375 mg/m2; One intravenous infusion once a week for 4 weeks

Primary Outcome Measures

Name	Time	Method
Overall Response Measured as Overall Response Rate (ORR) at Week 30 for BI 695500 Versus Rituximab	From first administration of study medication until 30 weeks thereafter.	The primary objective of this trial was to evaluate statistical equivalence of efficacy as assessed by Overall Response (measured as Overall Response Rate (ORR)) at Week 30 for treatment with BI 695500 versus rituximab (Rituxan®) in patients with untreated low tumor burden follicular lymphoma (LTBFL).; The overall response measured as Overall Response Rate (ORR), which is the completed response (CR) and the partial response (PR) at Week 30, approximately 26 weeks after the completion of study treatment, as defined by International Working Group (IWG) criteria 2007 via an independent radiology assessment.; Two patient were randomized and treated with BI 695500, whereas no patient was treated with rituximab in this trial.

Secondary Outcome Measures

Name	Time	Method
Extrapolated Area Under the Concentration-time Curve of BI 695500 or Rituximab at Steady State Over the Interval 0 Hour (h) to the Next Dose of Trial Medication (AUC0-τ, ss)	Sample timepoints Day 1, 8, 22, 23-24 (24-48 hours from start of Cycle 4 infusion), 24-26 (48-96 hours from start of Cycle 4 infusion), 26-36 (96-336 hours from start of Cycle 4 infusion), 78, 134, 204	Extrapolated area under the concentration-time curve of BI 695500 or rituximab in plasma at steady state over the interval 0 hour (h) to the next dose of trial medication (AUC0-τ, ss) established by population pharmacokinetics.
Immunogenicity at Week 30	Day 204 or end of study	Immunogenicity (rate of anti-drug antibodies) at Week 30 presented as the number of participants having Immunogenicity at Week 30.; This endpoint was not summarized for arm ' rituximab ', as two patient were randomized and treated with BI 695500, thus no patient was treated with rituximab in this trial.

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇨🇿 Praha, Czech Republic