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NCT01992653 · ClinicalTrials.gov registry record · Phase 1
A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
NCT01992653: Completed Phase 1 study, sponsored by Genentech.
NCT01992653 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 85 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01992653, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
Study Summary
This multicenter, open-label, dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of polatuzumab vedotin in combination with rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone (CHP chemotherapy) in participants with non-Hodgkin's lymphoma (NHL). Participants will receive escalating doses of polatuzumab vedotin intravenously (IV) every 3 weeks in combination with standard doses of rituximab plus CHP chemotherapy (R-CHP) or obinutuzumab plus CHP chemotherapy (G-CHP). Participants will be treated for a total of six or eight cycles in accordance with local institutional practice. Two parallel treatment arms will explore doses of polatuzumab vedotin in combination with R-CHP or G-CHP. The maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of polatuzumab vedotin in combination with R-CHP will be identified before it is combined with G-CHP. Once the MTD or RP2D is determined, polatuzumab vedotin will be dosed at MTD or RP2D -1 in combination with G-CHP to start the dose escalation of this combination.
Primary Outcome
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which wo
Interventions
- DRUG Obinutuzumab
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Prednisolone
- DRUG Polatuzumab Vedotin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2013-11-29 |
| Est. Completion | 2018-12-19 |
| Phase | Phase 1 |
What the finished NCT01992653 record still lists
NCT01992653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT01992653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01992653 about?
NCT01992653 is a clinical study titled "A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma". This multicenter, open-label, dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of polatuzumab vedotin in combination with rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone (CHP chemotherapy) in participants with non-Hodgki...
What is the current status of trial NCT01992653?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2013-11-29. Estimated completion is 2018-12-19.
What interventions are being tested in trial NCT01992653?
The interventions under investigation include: Obinutuzumab (DRUG), Cyclophosphamide (DRUG), Doxorubicin (DRUG), Prednisolone (DRUG), Polatuzumab Vedotin (DRUG).
Who is sponsoring clinical trial NCT01992653?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01992653's enrollment target sits among peer trials
85 656th of 2000 higher than 1,342 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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