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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 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 43 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05364424
The ClinicalTrials.gov registry entry for NCT05364424 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT05364424 reports 0 study locations.
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.
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