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COMPLETED 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)

NCT02611323 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 133 participants
Start Date 2016-03-09
Est. Completion 2022-08-04
Phase Phase 1

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02611323

The ClinicalTrials.gov registry entry for NCT02611323 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02611323 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Emilia-Romagna, New South Wales, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02611323?

The interventions under investigation include: Obinutuzumab (DRUG), Venetoclax (DRUG), Rituximab (DRUG), Polatuzumab Vedotin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02611323?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial