Field | Value |
---|---|
Trial Name | REACH3 |
DOI | https://doi.org/10.1056/NEJMoa2033122 |
Diagnosis | Chronic graft-versus-host disease, glucocorticoid-refractory or glucocorticoid-dependent |
Drugs | Ruxolitinib 10 mg twice daily |
Line Of Therapy | Second-line therapy |
Regimen | Ruxolitinib at a dose of 10 mg twice daily compared with investigator's choice of therapy |
Primary End Point | Overall response at week 24 |
Secondary End Point | Failure-free survival and improved score on the modified Lee Symptom Scale at week 24 |
Competitor Arm | Investigator's choice of therapy from a list of 10 commonly used options considered best available care |
Efficacy | Overall response at week 24 was greater in the ruxolitinib group than in the control group (49.7% vs. 25.6%) |
Response Types | Complete or partial response |
Time To Response | |
Surveillance | |
Subsets | Patients 12 years of age or older with moderate or severe glucocorticoid-refractory or -dependent chronic GVHD |
Adverse Events | Thrombocytopenia (15.2% in the ruxolitinib group and 10.1% in the control group) and anemia (12.7% and 7.6%, respectively) |
Others | REACH3 ClinicalTrials.gov number, NCT03112603 |
Conclusion | Ruxolitinib led to significantly greater overall response, failure-free survival, and symptom response among patients with glucocorticoid-refractory or -dependent chronic GVHD. |