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NCT03467373 · ClinicalTrials.gov registry record · 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
A Phase 1 study of Non-Hodgkin Lymphoma and B-cell Lymphoma, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 111
- Enrollment target
- 20
- Study locations
NCT03467373: Completed Phase 1 study of Non-Hodgkin Lymphoma and B-cell Lymphoma, sponsored by Hoffmann-La Roche.
NCT03467373 is a Phase 1 study of Non-Hodgkin Lymphoma and B-cell Lymphoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 111 participants, below the 167-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03467373, a Phase 1 study of Non-Hodgkin Lymphoma and B-cell Lymphoma, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 111 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2018-03-13 |
| Est. Completion | 2024-12-02 |
| Phase | Phase 1 |
What the finished NCT03467373 record still lists
NCT03467373 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 167-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (34% lower).
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.
NCT03467373 names 20 study sites across 9 states, led by Other, Lombardy, Alabama.
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.
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).
Who is sponsoring clinical trial NCT03467373?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
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Where NCT03467373's enrollment target sits among peer trials
111 34th of 106 higher than 73 of 106 other Non-Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
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