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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT04285567 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 166 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
MRD response rate was determined as the percentage of participants with MRD-negativity measured in the PB using NGS using a cutoff of \< 10\^-4. MRD was considered negative if the result was \< 1 CLL cell in 10,000 leukocytes. Percentages have been rounded off to the nearest decimal point.
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 |
What the finished NCT04285567 record still lists
NCT04285567 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT04285567 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04285567's enrollment target sits among peer trials
166 1463rd of 2000 higher than 536 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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