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NCT01691898 · ClinicalTrials.gov registry record · Phase 1
A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 231
- Enrollment target
NCT01691898: Completed Phase 1 study, sponsored by Genentech.
NCT01691898 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 231 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (285% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01691898, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 231 participants
- Enrollment target
Study Summary
This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX), as well as of polatuzumab vedotin in combination with obinutuzumab in participants with relapsed or refractory (r/r) follicular lymphoma (FL) and r/r diffuse large B-cell lymphoma (DLBCL).
Primary Outcome
Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments greater than or equal to (\>/=) 4 weeks after initial documentation. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as \>/=50 percent (%) decrease in sum of the products of
Interventions
- DRUG Obinutuzumab
- DRUG Rituximab
- DRUG Polatuzumab Vedotin
- DRUG Pinatuzumab Vedotin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2012-09-27 |
| Est. Completion | 2019-02-07 |
| Phase | Phase 1 |
What the finished NCT01691898 record still lists
NCT01691898 is an interventional study that assigns participants to a tested intervention. The registered 231 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 (285% higher).
The record links to 0 conditions, and to 4 interventions - of which Obinutuzumab is the first listed.
NCT01691898 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01691898 about?
NCT01691898 is a clinical study titled "A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)". This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX), as well as of polatuzumab vedotin in combination with obinutuzumab in participants with relapsed or refractory (r/r) fol...
What is the current status of trial NCT01691898?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 231 participants. The study started on 2012-09-27. Estimated completion is 2019-02-07.
What interventions are being tested in trial NCT01691898?
The interventions under investigation include: Obinutuzumab (DRUG), Rituximab (DRUG), Polatuzumab Vedotin (DRUG), Pinatuzumab Vedotin (DRUG).
Who is sponsoring clinical trial NCT01691898?
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 NCT01691898's enrollment target sits among peer trials
231 217th of 2000 higher than 1,782 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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