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NCT02417129 · ClinicalTrials.gov registry record · Phase 3
BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2
- Enrollment target
NCT02417129: Clinical Trial Phase 3 study, sponsored by Boehringer Ingelheim.
NCT02417129 is a Phase 3 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 2 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02417129, a Phase 3 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2 participants
- Enrollment target
Study 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.
Primary Outcome
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 tr
Interventions
- DRUG Rituximab
- DRUG BI 695500
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-04 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
Why NCT02417129 stopped before completion
NCT02417129 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT02417129 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02417129 about?
NCT02417129 is a clinical study titled "BI 695500 vs Rituxan First Line Treatment in Patients With Low Tumor Burden Follicular Lymphoma". 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 vi...
What is the current status of trial NCT02417129?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2 participants. The study started on 2015-04. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02417129?
The interventions under investigation include: Rituximab (DRUG), BI 695500 (DRUG).
Who is sponsoring clinical trial NCT02417129?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02417129's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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