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NCT02611323 · ClinicalTrials.gov registry record · Phase 1
A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)
A Phase 1 study of Non-Hodgkin's Lymphoma, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 133
- Enrollment target
- 20
- Study locations
NCT02611323: Completed Phase 1 study of Non-Hodgkin's Lymphoma, sponsored by Hoffmann-La Roche.
NCT02611323 is a Phase 1 study of Non-Hodgkin's Lymphoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 133 participants, below the 220-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02611323, a Phase 1 study of Non-Hodgkin's Lymphoma, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 133 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment with obinutuzumab, polatuzumab vedotin, and venetoclax in participants with relapsed or refractory FL, and with rituximab, polatuzumab vedotin, and venetoclax in participants with DLBCL. Participants with FL who achieve complete response (CR), partial response (PR), or stable disease (SD) at the end of induction therapy will receive post-induction treatment with obinutuzumab and venetoclax, and participants with DLBCL who achieve CR or PR at the end of induction (EOI) will receive post-induction treatment with rituximab and venetoclax.
Primary Outcome
CR at EOI was assessed by the IRC according to modified Lugano Response Criteria (MLRC) for Malignant Lymphoma 2014 using PET-CT scan. Per MLRC, CR was defined as complete metabolic response (MR) in lymph nodes and extra lymphatic sites (ELS) with a score of 1, 2, or 3, with or without a residual mass on PET 5-point scale (5-PS), where 1=no uptake above background; 2= uptake ≤mediastinum; 3= uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Venetoclax
- DRUG Rituximab
- DRUG Polatuzumab Vedotin
Study Locations (20)
Emilia-Romagna
- Papa Giovanni Hospital XXIII - Bergamo
- Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori - Meldola
- UO Ematologia, Ospedale S.Maria delle Croci - Ravenna
- Ospedale Infermi U.O. Ematologia - Rimini
New South Wales
- Royal North Shore Hospital; Haematology Department - St Leonards
- Calvary Mater Newcastle - Waratah
Arizona
- University of Arizona Cancer Center - Tucson
Connecticut
- Yale Cancer Center - New Haven
Florida
- Memorial Healthcare System - Pembroke
Georgia
- Emory Univ Winship Cancer Inst - Atlanta
Kentucky
- University of Louisville Hospital; The James Graham Brown Cancer Center - Louisville
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2016-03-09 |
| Est. Completion | 2022-08-04 |
| Phase | Phase 1 |
What the finished NCT02611323 record still lists
NCT02611323 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 220-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Non-Hodgkin's Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Obinutuzumab is the first listed.
NCT02611323 names 20 study sites across 16 states, led by Emilia-Romagna, New South Wales, Arizona.
Frequently Asked Questions
What is clinical trial NCT02611323 about?
NCT02611323 is a clinical study titled "A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)". This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment with obinutuzumab, polatuzumab vedotin, and venetoclax in participants with relapsed or refractory FL, and with rituximab, polatuzumab vedotin, and venetoclax in participants with DLBCL. Participants with FL w...
What is the current status of trial NCT02611323?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 133 participants. The study started on 2016-03-09. Estimated completion is 2022-08-04.
What conditions does trial NCT02611323 study?
This clinical trial studies the following conditions: Non-Hodgkin's Lymphoma.
What interventions are being tested in trial NCT02611323?
The interventions under investigation include: Obinutuzumab (DRUG), Venetoclax (DRUG), Rituximab (DRUG), Polatuzumab Vedotin (DRUG).
Who is sponsoring clinical trial NCT02611323?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02611323 being conducted?
This trial has 20 study locations across Arizona, Connecticut, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02611323's enrollment target sits among peer trials
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