# 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

> **NCT04285567** · PHASE3 · COMPLETED · sponsor: **Hoffmann-La Roche** · enrollment: 166 (actual)

## Conditions studied

- Chronic Lymphocytic Leukemia (CLL)

## Interventions

- **DRUG:** Obinutuzumab
- **DRUG:** Venetoclax
- **DRUG:** Fludarabine
- **DRUG:** Cyclophosphamide
- **DRUG:** Rituximab
- **DRUG:** Bendamustine

## Key facts

- **NCT ID:** NCT04285567
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-05-28
- **Primary completion:** 2024-03-19
- **Final completion:** 2025-03-19
- **Target enrollment:** 166 (ACTUAL)
- **Last updated:** 2026-03-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04285567

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04285567, "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". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT04285567. Licensed CC0.

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