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NCT05364424 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT05364424: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT05364424 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05364424, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the preliminary efficacy, safety, and pharmacokinetics of glofitamab (glofit) in combination with rituximab plus ifosfamide, carboplatin, and etoposide (R-ICE) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have failed one prior line of therapy incorporating an anti-cluster of differentiation (CD) 20 antibody (i.e., rituximab) and an anthracycline, and who are transplant or chimeric antigen receptor T-cell (CAR-T) therapy eligible, defined as being medically eligible for intensive platinum-based salvage therapy followed by autologous stem cell transplantation (ASCT) or for CAR-T therapy.
Interventions
- DRUG Obinutuzumab
- DRUG Glofitamab
- DRUG Rituximab
- DRUG Ifosfamide
- DRUG Tocilizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2022-11-04 |
| Est. Completion | 2025-10-15 |
| Phase | Phase 1 |
What the finished NCT05364424 record still lists
NCT05364424 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT05364424 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05364424 about?
NCT05364424 is a clinical study titled "A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma". The purpose of this study is to evaluate the preliminary efficacy, safety, and pharmacokinetics of glofitamab (glofit) in combination with rituximab plus ifosfamide, carboplatin, and etoposide (R-ICE) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have f...
What is the current status of trial NCT05364424?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2022-11-04. Estimated completion is 2025-10-15.
What interventions are being tested in trial NCT05364424?
The interventions under investigation include: Obinutuzumab (DRUG), Glofitamab (DRUG), Rituximab (DRUG), Ifosfamide (DRUG), Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT05364424?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05364424's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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