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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 is a Phase 3 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 2 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02417129
The ClinicalTrials.gov registry entry for NCT02417129 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT02417129 reports 0 study locations.
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.
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