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NCT03135262 · ClinicalTrials.gov registry record · Phase 1
A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL)
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT03135262 is a Phase 1 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 29 participants.
The verdict
NCT03135262, a Phase 1 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
This Phase Ib/II, open-label, multicenter, non-randomized, dose-escalation study will evaluate the safety, efficacy, and pharmacokinetics of obinutuzumab in combination with idasanutlin and venetoclax in participants with R/R FL and obinutuzumab or rituximab in combination with idasanutlin and venetoclax in participants with R/R DLBCL. The study will include an initial dose-escalation phase followed by an expansion phase. The dose-escalation phase is designed to determine the recommended phase II doses (RP2Ds) and regimen for idasanutlin and venetoclax in combination with obinutuzumab for FL participants and in combination with rituximab for DLBCL participants.
Interventions
- DRUG Obinutuzumab
- DRUG Venetoclax
- DRUG Rituximab
- DRUG Idasanutlin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2017-06-15 |
| Est. Completion | 2020-04-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03135262
The ClinicalTrials.gov registry entry for NCT03135262 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 29 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 4 interventions - of which Obinutuzumab is the first listed.
NCT03135262 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03135262 about?
NCT03135262 is a clinical study titled "A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL)". This Phase Ib/II, open-label, multicenter, non-randomized, dose-escalation study will evaluate the safety, efficacy, and pharmacokinetics of obinutuzumab in combination with idasanutlin and venetoclax in participants with R/R FL and obinutuzumab or rituximab in combination with idasanutlin and venet...
What is the current status of trial NCT03135262?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2017-06-15. Estimated completion is 2020-04-30.
What interventions are being tested in trial NCT03135262?
The interventions under investigation include: Obinutuzumab (DRUG), Venetoclax (DRUG), Rituximab (DRUG), Idasanutlin (DRUG).
Who is sponsoring clinical trial NCT03135262?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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