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NCT03817853 · ClinicalTrials.gov registry record · Phase 4
An Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion in Patients With Previously Untreated Advanced Follicular Lymphoma
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 114
- Enrollment target
NCT03817853 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 114 participants.
The verdict
NCT03817853, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 114 participants
- Enrollment target
Study Summary
This open-label, single arm study will evaluate the safety of obinutuzumab administered as a short duration infusion (SDI; target 90-minute infusion) during cycle 2 and from cycle 2 onwards in combination with chemotherapy in participants with previously untreated advanced follicular lymphoma (FL). The study has two phases: in the first phase, participants will receive the first cycle of obinutuzumab-based chemotherapy (G-chemo) induction therapy as usual with the first three infusions of obinutuzumab (1000 mg) administered at the regular infusion rate on Day 1, 8, and 15 of cycle 1. Phase 2 starts when participants who do not experience any Grade ≥ 3 infusion related reactions during the first cycle receive their first obintuzumab infusion given at the faster infusion rate in Cycle 2. For Cycle 2, Day 1 and all other following infusions (including maintenance), obinutuzumab will be administered at a faster infusion of 90-minute SDI, as long as the participant does not experience any Grade ≥ 3 infusion related reactions. The investigator is free to choose the chemotherapy for each participant (bendamustine, CHOP \[cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone/methylprednisolone\], or CVP \[cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone\]). The total number of cycles of G-chemo induction therapy and the cycles length depends on the chemotherapy chosen for each participant.
Interventions
- DRUG Obinutuzumab
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Bendamustine
- DRUG Prednisone/Prednisolone/Methylprednisolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2019-02-26 |
| Est. Completion | 2023-01-25 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03817853
The ClinicalTrials.gov registry entry for NCT03817853 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 114 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.
NCT03817853 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03817853 about?
NCT03817853 is a clinical study titled "An Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion in Patients With Previously Untreated Advanced Follicular Lymphoma". This open-label, single arm study will evaluate the safety of obinutuzumab administered as a short duration infusion (SDI; target 90-minute infusion) during cycle 2 and from cycle 2 onwards in combination with chemotherapy in participants with previously untreated advanced follicular lymphoma (FL). ...
What is the current status of trial NCT03817853?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 114 participants. The study started on 2019-02-26. Estimated completion is 2023-01-25.
What interventions are being tested in trial NCT03817853?
The interventions under investigation include: Obinutuzumab (DRUG), Cyclophosphamide (DRUG), Doxorubicin (DRUG), Bendamustine (DRUG), Prednisone/Prednisolone/Methylprednisolone (DRUG).
Who is sponsoring clinical trial NCT03817853?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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