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NCT02257567 · ClinicalTrials.gov registry record · Phase 1
A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma
A Phase 1 study of Lymphoma, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 331
- Enrollment target
- 20
- Study locations
NCT02257567: Completed Phase 1 study of Lymphoma, sponsored by Hoffmann-La Roche.
NCT02257567 is a Phase 1 study of Lymphoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 331 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02257567, a Phase 1 study of Lymphoma, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 331 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with standard doses of bendamustine (B) and rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18 weeks for participants with DLBCL and 24 weeks for participants with FL.
Primary Outcome
An AE 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 AE 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 worsen during a study ar
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Rituximab
- DRUG Bendamustine
- DRUG Polatuzumab vedotin (Liquid)
- DRUG Polatuzumab vedotin (Lyophilized)
Study Locations (20)
Alabama
- University of Alabama at Birmingham - Birmingham
- Clearview Cancer Institute - Huntsville
Washington
- Swedish Cancer Inst. - Seattle
- Northwest Medical Specialties - Tacoma
South Australia
- Royal Adelaide Hospital - Adelaide
- Adelaide Cancer Centre - Kurralta Park
California
- City of Hope National Medical Center - Duarte
Colorado
- Univ of Colorado Canc Ctr - Aurora
Florida
- Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) - Jacksonville
Georgia
- Emory Univ Winship Cancer Inst - Atlanta
Illinois
- Joliet Oncology-Hematology; Associates, Ltd. - Joliet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2014-10-15 |
| Est. Completion | 2021-10-21 |
| Phase | Phase 1 |
What the finished NCT02257567 record still lists
NCT02257567 is an interventional study that assigns participants to a tested intervention. The registered 331 participants enrollment target is mid-sized for trials with a published cap, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT02257567 names 20 study sites across 17 states, led by Alabama, Washington, South Australia.
Frequently Asked Questions
What is clinical trial NCT02257567 about?
NCT02257567 is a clinical study titled "A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma". This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with standard doses of bendamustine (B) and rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lym...
What is the current status of trial NCT02257567?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 331 participants. The study started on 2014-10-15. Estimated completion is 2021-10-21.
What conditions does trial NCT02257567 study?
This clinical trial studies the following conditions: Lymphoma.
What interventions are being tested in trial NCT02257567?
The interventions under investigation include: Obinutuzumab (DRUG), Rituximab (DRUG), Bendamustine (DRUG), Polatuzumab vedotin (Liquid) (DRUG), Polatuzumab vedotin (Lyophilized) (DRUG).
Who is sponsoring clinical trial NCT02257567?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02257567 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02257567's enrollment target sits among peer trials
331 29th of 299 higher than 271 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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.
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