# GLOW

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

## TL;DR

Fifteen months of two oral drugs cut the risk of progression by nearly 80% versus chemoimmunotherapy in older patients, and later showed a survival advantage.

## Summary

GLOW, trial NCT03462719 sponsored by Janssen and published in NEJM Evidence in 2022, showed that fifteen months of ibrutinib and venetoclax cut the risk of progression by nearly eighty percent versus chlorambucil plus obinutuzumab in older or comorbid patients with previously untreated chronic lymphocytic leukaemia without del(17p), and later showed a survival advantage. It randomised 211 patients, met its primary progression-free survival endpoint with far higher rates of undetectable MRD in marrow, and the four-year update showed improved overall survival; the European Union approved the regimen in 2022 but it is not FDA-approved. OnCo links it to chronic lymphocytic leukaemia, BTK and BCL-2 as targets, ibrutinib, venetoclax, obinutuzumab and the fixed-duration pairing, and CAPTIVATE, AMPLIFY and FLAIR support the approach. Whether the regimen reaches US patients is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03462719
- Phase: 3
- Setting: Previously untreated CLL, age ≥65 or with comorbidities, no del(17p)/TP53: fixed-duration ibrutinib + venetoclax vs chlorambucil + obinutuzumab
- Sponsor: Janssen
- Enrolled: 211
- Result: PFS HR 0.216; OS HR 0.487 (4-year).
- Outcomes: Progression-free survival: Ibrutinib + venetoclax vs Chlorambucil + obinutuzumab, HR 0.216; Undetectable MRD in bone marrow at 3 months post-treatment: Ibrutinib + venetoclax 51.9% vs Chlorambucil + obinutuzumab 17.1%
- Replication: CAPTIVATE (single-arm, younger) and AMPLIFY (acalabrutinib-venetoclax) support BTKi + BCL2i fixed duration; FLAIR (UK, ibrutinib-venetoclax vs FCR) also positive.

## Sources

- ClinicalTrials.gov NCT03462719: https://clinicaltrials.gov/study/NCT03462719

## Connected records

- cancers: [Chronic lymphocytic leukaemia](https://onco.cc/cancers/cll/), [Chronic lymphocytic leukaemia, first treatment](https://onco.cc/cancers/cll-treatment-naive/)
- technologies: [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/)
- drugs: [Ibrutinib](https://onco.cc/drugs/ibrutinib/), [Obinutuzumab](https://onco.cc/drugs/obinutuzumab/), [Venetoclax](https://onco.cc/drugs/venetoclax/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- pairings: [BTK inhibitor + venetoclax, fixed duration](https://onco.cc/pairings/btki-plus-venetoclax-fixed-duration/)
- 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/)

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