# CLL14

Source: https://onco.cc/trials/cll14/  
OnCo record `cll14` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

One year of two targeted drugs, then nothing: more than half of patients were still progression-free six years later, off all treatment.

## Summary

Median PFS 76.2 vs 36.4 months (HR 0.40); 6-year PFS 53.1% vs 21.7%; time to next treatment 65.2% vs 37.1% at 6 years; uMRD at end of treatment 75.5% vs 35.2%; OS difference not statistically significant. NEJM 2019; Blood 2024 (6-year). Established fixed-duration therapy as a CLL standard and uMRD as a predictor of durable remission.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT02242942
- Phase: 3
- Setting: Previously untreated CLL with coexisting conditions: 12 months of venetoclax + obinutuzumab vs chlorambucil + obinutuzumab
- Sponsor: German CLL Study Group / Roche / AbbVie
- Enrolled: 445
- Result: 6-year PFS 53.1% vs 21.7%; HR 0.40.
- Outcomes: Progression-free survival (median): Venetoclax + obinutuzumab 76.2 months vs Chlorambucil + obinutuzumab 36.4 months, HR 0.4; Progression-free survival at 6 years: Venetoclax + obinutuzumab 53.1% vs Chlorambucil + obinutuzumab 21.7%; Undetectable MRD in blood at end of treatment: Venetoclax + obinutuzumab 75.5% vs Chlorambucil + obinutuzumab 35.2%
- Replication: CLL13/GAIA (fit patients) reproduced venetoclax-obinutuzumab superiority over chemoimmunotherapy; real-world registries confirm ~2-year PFS >85%.

## Sources

- ClinicalTrials.gov NCT02242942: https://clinicaltrials.gov/study/NCT02242942

## Connected records

- cancers: [Chronic lymphocytic leukaemia](https://onco.cc/cancers/cll/), [Chronic lymphocytic leukaemia, first treatment](https://onco.cc/cancers/cll-treatment-naive/)
- technologies: [BCL-2 inhibitors](https://onco.cc/technologies/bcl2-inhibitors/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [BCL-2](https://onco.cc/targets/bcl2/), [CD20](https://onco.cc/targets/cd20/)
- drugs: [Obinutuzumab](https://onco.cc/drugs/obinutuzumab/), [Venetoclax](https://onco.cc/drugs/venetoclax/)
- companies: [German CLL Study Group](https://onco.cc/companies/german-cll-study-group/)
- terms: [MRD-negative complete remission](https://onco.cc/terms/mrd-negative-cr/), [Tumour lysis syndrome (TLS)](https://onco.cc/terms/tumor-lysis-syndrome/)
- people: [Kirsten Fischer](https://onco.cc/people/kirsten-fischer/), [Michael Hallek](https://onco.cc/people/michael-hallek/)
- pairings: [Venetoclax + obinutuzumab (12 months)](https://onco.cc/pairings/venetoclax-plus-obinutuzumab/)
- bottlenecks: [Older and multimorbid patients are excluded and undertreated](https://onco.cc/bottlenecks/b-aging-comorbidity/)
- key papers: [CLL14: one year of venetoclax plus obinutuzumab instead of chemo-immunotherapy in older, less fit CLL patients](https://onco.cc/key-papers/paper-cll14-venetoclax-obinutuzumab-nejm-2019/)

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