# COMFORT-II

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

## TL;DR

COMFORT-II was the European companion to COMFORT-I: ruxolitinib shrank the spleen by more than a third in 28 percent of people with myelofibrosis after nearly a year, while not one patient on the best treatment their doctor could otherwise offer achieved that, and symptoms and quality of life improved.

## Summary

COMFORT-II was an open-label phase 3 trial in Europe that randomised 219 patients with intermediate-2 or high-risk myelofibrosis two to one to ruxolitinib or best available therapy, which for most patients meant hydroxycarbamide or no treatment. The primary endpoint was a spleen volume reduction of at least 35 percent at week 48 on MRI or CT, with the same reduction at week 24 as the key secondary endpoint.

At week 48, 28 percent of the ruxolitinib group had reached the spleen endpoint against none on best available therapy, responses were durable, and role functioning and quality-of-life scores improved. Toxicity was modest, mainly anaemia and thrombocytopenia. The trial supported the European approval of ruxolitinib in 2012, and pooled long-term analyses with COMFORT-I later suggested a survival advantage.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-22
- Also known as: COMFORT; CINC424A2352
- Tags: soc-trials
- Registry id: NCT00934544
- Phase: 3
- Setting: Intermediate-2 or high-risk primary myelofibrosis, post-polycythaemia vera or post-essential thrombocythaemia myelofibrosis: open-label ruxolitinib against best available therapy chosen by the physician, with spleen volume at 48 weeks as the primary endpoint
- Sponsor: Novartis Pharmaceuticals
- Enrolled: 219
- Result: Spleen volume reduction of at least 35 percent at week 48 in 28 percent of patients on ruxolitinib against 0 percent on best available therapy; European approval in 2012.
- Outcomes: Spleen volume reduction of 35% or more at week 48 (MRI or CT): Ruxolitinib 28% vs Best available therapy 0%; Spleen volume reduction of 35% or more at week 48 (registry results): Ruxolitinib 28.5% vs Best available therapy 0%

## Sources

- ClinicalTrials.gov NCT00934544: https://clinicaltrials.gov/study/NCT00934544

## Connected records

- cancers: [Myeloproliferative neoplasms (PV, ET, myelofibrosis)](https://onco.cc/cancers/myeloproliferative-neoplasms/), [Primary myelofibrosis](https://onco.cc/cancers/primary-myelofibrosis/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Ruxolitinib](https://onco.cc/drugs/ruxolitinib/)
- companies: [Novartis](https://onco.cc/companies/novartis/)
- key papers: [COMFORT-II: JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis](https://onco.cc/key-papers/paper-comfort-ii-ruxolitinib-best-available-therapy-harrison-nejm-2012/)

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