# CLL13 / GAIA

Source: https://onco.cc/trials/cll13-gaia/  
OnCo record `cll13-gaia` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In fit patients, one year of venetoclax plus obinutuzumab (with or without ibrutinib) clearly beat the old chemotherapy standard.

## Summary

Co-primary endpoints: uMRD at month 15 (GIV 92.2%, GV 86.5%, RV 57.0%, CIT 52.0%) and PFS (GIV and GV superior to CIT; RV not). 5-year PFS: GIV 81.3%, GV 69.8%, RV 57.4%, CIT 50.7%; 5-year OS 91-95% in all arms. NEJM 2023; 5-year update 2025-26. Showed that venetoclax needs obinutuzumab rather than rituximab, and that adding ibrutinib improves PFS at the cost of more toxicity.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT02950051
- Phase: 3
- Setting: Fit, previously untreated CLL without del(17p)/TP53: chemoimmunotherapy (FCR/BR) vs venetoclax-rituximab vs venetoclax-obinutuzumab vs venetoclax-obinutuzumab-ibrutinib
- Sponsor: German CLL Study Group
- Enrolled: 926
- Result: 5-year PFS 81.3% (GIV), 69.8% (GV), 57.4% (RV), 50.7% (CIT).
- Outcomes: Undetectable MRD at month 15 (blood): GIV 92.2% vs GV 86.5% vs RV 57% vs Chemoimmunotherapy 52%; Progression-free survival at 5 years: GIV 81.3% vs GV 69.8% vs RV 57.4% vs Chemoimmunotherapy 50.7%
- Replication: Consistent with CLL14 (unfit) and with AMPLIFY (acalabrutinib-venetoclax ± obinutuzumab), which also showed the triplet with obinutuzumab gives the highest PFS.

## Sources

- ClinicalTrials.gov NCT02950051: https://clinicaltrials.gov/study/NCT02950051

## 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/), [BTK (Bruton tyrosine kinase)](https://onco.cc/targets/btk/), [CD20](https://onco.cc/targets/cd20/)
- drugs: [Ibrutinib](https://onco.cc/drugs/ibrutinib/), [Obinutuzumab](https://onco.cc/drugs/obinutuzumab/), [Rituximab](https://onco.cc/drugs/rituximab/), [Venetoclax](https://onco.cc/drugs/venetoclax/)
- companies: [German CLL Study Group](https://onco.cc/companies/german-cll-study-group/)
- terms: [IGHV mutational status](https://onco.cc/terms/ighv-status/), [MRD-negative complete remission](https://onco.cc/terms/mrd-negative-cr/)
- people: [Barbara Eichhorst](https://onco.cc/people/barbara-eichhorst/), [Michael Hallek](https://onco.cc/people/michael-hallek/)
- pairings: [Venetoclax + obinutuzumab (12 months)](https://onco.cc/pairings/venetoclax-plus-obinutuzumab/)
- key papers: [AMPLIFY: fixed-duration acalabrutinib plus venetoclax, with or without obinutuzumab, versus chemo-immunotherapy in fit CLL patients](https://onco.cc/key-papers/paper-amplify-acalabrutinib-venetoclax-nejm-2025/), [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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