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NCT02596971 · ClinicalTrials.gov registry record · Phase 1
A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 91
- Enrollment target
NCT02596971: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT02596971 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 91 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02596971, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 91 participants
- Enrollment target
Study Summary
This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment consisting of atezolizumab in combination with either obinutuzumab + bendamustine (Atezo-G-benda) or obinutuzumab + CHOP (Atezo-G-CHOP) in participants with FL and atezolizumab + rituximab + chemotherapy (Atezo-R-CHOP) in participants with DLBCL, followed by post-induction treatment consisting of either atezolizumab plus obinutuzumab (Atezo-G) in participants with FL who achieve a complete response (CR) or partial response (PR) at end of induction (EOI) or atezolizumab alone in participants with DLBCL who achieve a CR at EOI.
Primary Outcome
Primary end point was positron emission tomography (PET) CR at EOI by IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to \[\</=\] mediastinum), or 3 (uptake less than \[\<\] mediastinum but \</=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow; an
Interventions
- DRUG Obinutuzumab
- DRUG Cyclophosphamide
- DRUG Atezolizumab
- DRUG Doxorubicin
- DRUG Bendamustine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2015-12-22 |
| Est. Completion | 2020-05-08 |
| Phase | Phase 1 |
What the finished NCT02596971 record still lists
NCT02596971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% higher).
The record links to 0 conditions, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT02596971 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02596971 about?
NCT02596971 is a clinical study titled "A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL)". This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment consisting of atezolizumab in combination with either obinutuzumab + bendamustine (Atezo-G-benda) or obinutuzumab + CHOP (Atezo-G-CHOP) in participants with...
What is the current status of trial NCT02596971?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 91 participants. The study started on 2015-12-22. Estimated completion is 2020-05-08.
What interventions are being tested in trial NCT02596971?
The interventions under investigation include: Obinutuzumab (DRUG), Cyclophosphamide (DRUG), Atezolizumab (DRUG), Doxorubicin (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT02596971?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02596971's enrollment target sits among peer trials
91 626th of 2000 higher than 1,373 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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