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COMPLETED Phase 1

A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL

NCT03467373 · View on ClinicalTrials.gov ↗

Study Summary

This is a phase 1B, multi-center, dose-finding study of glofitamab administered in combination with obinutuzumab (Gazyva; \[G\]), rituximab (R) and standard doses of CHOP (G/R-CHOP or R-CHOP) in participants with r/r NHL and G/R CHOP or Pola-R-CHP in participants with untreated diffuse large B-cell lymphoma (DLBCL). Evaluating the safety, preliminary activity, pharmacokinetic (PK), and pharmacodynamic effects of this combination will be the main objectives of this study. The study is divided in two parts: * Part I: Dose finding in participants with r/r NHL; test use of G vs R in Cycle 1 * Part II: Dose Expansion. The maximum tolerated dose or optimal biological dose (MTD or OBD) will be further assessed in participants with untreated DLBCL (\>18 years of age with an age-adjusted International Prognostic Index (IPI) of 2-5). Glofitamab will be studied in combination with R-CHOP and Pola-R-CHP.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Glofitamab
  • DRUG Tocilizumab
  • DRUG Obinutuzumab (G)
  • DRUG Rituximab (R)

Study Locations (20)

Other

  • Rigshospitalet — København Ø
  • Hopital Claude Huriez — Lille
  • Hopital Hotel Dieu Et Hme — Nantes
  • Centre Henri Becquerel — Rouen
  • Universitätsklinikum Erlangen, Translational Research Center (TRC), Medizin 5 — Erlangen
  • Universitätsklinikum Freiburg — Freiburg im Breisgau
  • Universitätsklinikum Ulm — Ulm
  • Universitätsklinikum Würzburg — Würzburg
  • Hospital Universitari Vall d'Hebron — Barcelona
  • Hospital Clínic i Provincial — Barcelona
  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz — Madrid

Lombardy

  • Asst Papa Giovanni Xxiii — Bergamo
  • Istituto Clinico Humanitas — Rozzano

Alabama

  • University of Alabama Medical Center — Birmingham

North Carolina

  • Levine Cancer Institute — Charlotte

Pennsylvania

  • Fox Chase-Temple Cancer Center — Philadelphia

Victoria

  • Peter Maccallum Cancer Centre — Melbourne

Ontario

  • Princess Margaret Cancer Center — Toronto

Campania

  • Istituto Nazionale Tumori Irccs Fondazione g. Pascale — Naples

Trial Details

FieldValue
Enrollment Target 111 participants
Start Date 2018-03-13
Est. Completion 2024-12-02
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 NCT03467373

The ClinicalTrials.gov registry entry for NCT03467373 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 111 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 2 conditions, with Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide 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: NCT03467373 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Lombardy, Alabama. 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 NCT03467373 about?

NCT03467373 is a clinical study titled "A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL". This is a phase 1B, multi-center, dose-finding study of glofitamab administered in combination with obinutuzumab (Gazyva; \[G\]), rituximab (R) and standard doses of CHOP (G/R-CHOP or R-CHOP) in participants with r/r NHL and G/R CHOP or Pola-R-CHP in participants with untreated diffuse large B-cell ...

What is the current status of trial NCT03467373?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 111 participants. The study started on 2018-03-13. Estimated completion is 2024-12-02.

What conditions does trial NCT03467373 study?

This clinical trial studies the following conditions: Non-Hodgkin Lymphoma, B-Cell 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 NCT03467373?

The interventions under investigation include: Cyclophosphamide (DRUG), Glofitamab (DRUG), Tocilizumab (DRUG), Obinutuzumab (G) (DRUG), Rituximab (R) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03467373?

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 NCT03467373 being conducted?

This trial has 20 study locations across Alabama, North Carolina, Pennsylvania, Victoria, Ontario. 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