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NCT02600897 · ClinicalTrials.gov registry record · Phase 1
A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 114
- Enrollment target
NCT02600897: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT02600897 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 114 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02600897, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 114 participants
- Enrollment target
Study Summary
This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment with obinutuzumab, polatuzumab vedotin, and lenalidomide in participants with relapsed or refractory (R/R) follicular lymphoma (FL) and rituximab in combination with polatuzumab vedotin and lenalidomide in participants with R/R diffuse large B-cell lymphoma (DLBCL), followed by post-induction treatment with obinutuzumab in combination with lenalidomide in participants with FL who achieve a complete response (CR), partial response (PR), or stable disease (SD) at end of induction (EOI) and post-induction treatment with rituximab plus lenalidomide in participants with DLBCL who achieve a CR or PR at EOI.
Primary Outcome
A DLT was defined as any one of the following toxicities occurring during the first cycle of treatment and assessed by the investigator as related to study treatment: Any adverse event of any grade that lead to a delay of \> 14 days in the start of the next treatment cycle, Grade 3 or 4 non-hematologic adverse events with few exceptions; increase in hepatic transaminase \> 3 x baseline and an increase in direct bilirubin \> 2 x upper limits of normal (ULN), without any findings of cholestasis or
Interventions
- DRUG Obinutuzumab
- DRUG Rituximab
- DRUG Lenalidomide
- DRUG Polatuzumab Vedotin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2016-03-24 |
| Est. Completion | 2021-12-15 |
| Phase | Phase 1 |
What the finished NCT02600897 record still lists
NCT02600897 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% higher).
The record links to 0 conditions, and to 4 interventions - of which Obinutuzumab is the first listed.
NCT02600897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02600897 about?
NCT02600897 is a clinical study titled "A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)". This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment with obinutuzumab, polatuzumab vedotin, and lenalidomide in participants with relapsed or refractory (R/R) follicular lymphoma (FL) and rituximab in combination with polatuzumab vedotin and lenalidomide in par...
What is the current status of trial NCT02600897?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 114 participants. The study started on 2016-03-24. Estimated completion is 2021-12-15.
What interventions are being tested in trial NCT02600897?
The interventions under investigation include: Obinutuzumab (DRUG), Rituximab (DRUG), Lenalidomide (DRUG), Polatuzumab Vedotin (DRUG).
Who is sponsoring clinical trial NCT02600897?
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 NCT02600897's enrollment target sits among peer trials
114 507th of 2000 higher than 1,493 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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