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NCT04285567 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 166
- Enrollment target
NCT04285567 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 166 participants.
The verdict
NCT04285567, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 166 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale \[CIRS\]/score of ≤6 and a normal creatinine clearance of ≥70 mL/min) with previously untreated CLL without DEL(17P) or TP53 mutation requiring treatment. Eligible participants will be randomly assigned in a 1:1 ratio to receive either VEN + G (Arm A) or FCR/BR (Arm B).
Interventions
- DRUG Obinutuzumab
- DRUG Venetoclax
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2020-05-28 |
| Est. Completion | 2025-03-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04285567
The ClinicalTrials.gov registry entry for NCT04285567 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 166 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.
NCT04285567 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04285567 about?
NCT04285567 is a clinical study titled "A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation". This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale \[CIRS\]/score of ≤6 and a normal creatinin...
What is the current status of trial NCT04285567?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 166 participants. The study started on 2020-05-28. Estimated completion is 2025-03-19.
What interventions are being tested in trial NCT04285567?
The interventions under investigation include: Obinutuzumab (DRUG), Venetoclax (DRUG), Cyclophosphamide (DRUG), Fludarabine (DRUG), Rituximab (DRUG).
Who is sponsoring clinical trial NCT04285567?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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