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NCT02187861 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating the Safety and Efficacy of Venetoclax (GDC-0199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or Venetoclax Plus Rituximab in Participants With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma (fNHL)
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 163
- Enrollment target
NCT02187861 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 163 participants.
The verdict
NCT02187861, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 163 participants
- Enrollment target
Study Summary
This open-label, international, multicenter study will investigate the safety and efficacy of venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR) compared with BR alone in participants with relapsed and refractory fNHL, comparing two chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an exploratory analysis of the safety and efficacy of venetoclax in combination with rituximab (venetoclax + rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be decided at the discretion of the Investigator, unless one of the cohorts is not open to enrollment; in which case, participants may be enrolled only to the open cohort. The first 6 participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will comprise the Safety Run-In group for Treatment Arm B, dosing venetoclax at 600 milligrams (mg) in combination with BR. Once a dose has been chosen from the Safety Run-In Period, randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C) will begin.
Interventions
- DRUG Venetoclax
- DRUG Rituximab
- DRUG Bendamustine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2014-12-01 |
| Est. Completion | 2018-03-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02187861
The ClinicalTrials.gov registry entry for NCT02187861 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 163 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT02187861 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02187861 about?
NCT02187861 is a clinical study titled "A Study Evaluating the Safety and Efficacy of Venetoclax (GDC-0199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or Venetoclax Plus Rituximab in Participants With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma (fNHL)". This open-label, international, multicenter study will investigate the safety and efficacy of venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR) compared with BR alone in participants with relapsed and refractory fNHL, comparing two chemotherapy-containing regime...
What is the current status of trial NCT02187861?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 163 participants. The study started on 2014-12-01. Estimated completion is 2018-03-16.
What interventions are being tested in trial NCT02187861?
The interventions under investigation include: Venetoclax (DRUG), Rituximab (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT02187861?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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