A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)
Summary
The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).
Timeline
- Start
- 2017-06-29
- Primary completion
- 2020-05-08
- Completion
- 2022-12-15
Outcome
Met primary endpoint
paper Overall response at week 24 was greater in the ruxolitinib group than in the control group (49.7% vs. 25.6%; odds ratio, 2.99; P<0.001). PMID 34260836 ↗
release “REACH3 study evaluating ruxolitinib (Jakafi®) in patients with moderate or severe steroid-refractory or steroid dependent chronic graft-versus-host disease (GVHD) met its primary endpoint” incyte.com ↗
release “REACH3 study evaluating Jakavi ® (ruxolitinib) in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GvHD) met its primary endpoint” novartis.com ↗
release “In REACH3, patients treated with Jakafi achieved significantly greater overall response rate (ORR) compared to BAT (49.7% vs. 25.6%; p<0.00015) at Week 24, the primary endpoint” incyte.com ↗
release “Jakavi Phase III REACH3 study, presented at the American Society of Hematology, met its primary endpoint” novartis.com ↗
release “Phase 3 REACH3 data show that ruxolitinib (Jakafi®) significantly improved overall response rate (ORR) at Week 24 (49.7% vs. 25.6%)” incyte.com ↗
release “In REACH3, treatment with ruxolitinib led to significant improvements in ORR compared to BAT (49.7% vs. 25.6%; OR, 2.99; P<0.0001)” incyte.com ↗
release “In REACH3, treatment with Jakavi led to significant improvements in ORR compared to BAT (49.7% vs. 25.6%;” novartis.com ↗
Publications
- Mahmoudjafari Z, Bhatt V, Xue Z, Locatelli F, Socie G, Zeiser R. Clinical considerations for ruxolitinib in the treatment of steroid-refractory acute graft-versus-host disease (GVHD) and steroid-refractory or -dependent chronic GVHD: a plain language summary. Ther Adv Hematol. 2026 May 19;17:20406207261442908. doi: 10.1177/20406207261442908. eCollection 2026.
- Zeiser R, Russo D, Ram R, Hashmi SK, Chakraverty R, Middeke JM, Musso M, Giebel S, Uzay A, Langmuir P, Hamad N, Burock K, Gowda M, Stefanelli T, Lee SJ, Teshima T, Locatelli F. Ruxolitinib in Patients With Corticosteroid-Refractory or Corticosteroid-Dependent Chronic Graft-Versus-Host Disease: 3-Year Final Analysis of the Phase III REACH3 Study. J Clin Oncol. 2025 Aug 10;43(23):2566-2571. doi: 10.1200/JCO-24-02477. Epub 2025 Jun 25.
- Mahmoudjafari Z, Kintsch E, Xue Z, Bhatt V, Galvin J, Locatelli F, Zeiser R. Impact of concomitant azoles on ruxolitinib treatment in patients with GVHD: post hoc analyses of REACH2 and REACH3. Blood Adv. 2025 Aug 26;9(16):4206-4216. doi: 10.1182/bloodadvances.2025016212.
- Le RQ, Wang X, Zhang H, Li H, Przepiorka D, Vallejo J, Leong R, Ma L, Goldberg KB, Pazdur R, Theoret MR, De Claro A. FDA Approval Summary: Ruxolitinib for Treatment of Chronic Graft-Versus-Host Disease after Failure of One or Two Lines of Systemic Therapy. Oncologist. 2022 Jun 8;27(6):493-500. doi: 10.1093/oncolo/oyac042.
- Zeiser R, Polverelli N, Ram R, Hashmi SK, Chakraverty R, Middeke JM, Musso M, Giebel S, Uzay A, Langmuir P, Hollaender N, Gowda M, Stefanelli T, Lee SJ, Teshima T, Locatelli F; REACH3 Investigators. Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease. N Engl J Med. 2021 Jul 15;385(3):228-238. doi: 10.1056/NEJMoa2033122.
- Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ruxolitinib | Small molecule | 10 mg | — |
| Comparator | Everolimus | Small molecule | — | — |
| Comparator | Ibrutinib | Small molecule | — | — |
| Comparator | Imatinib | Small molecule | — | — |
| Comparator | Infliximab | Monoclonal antibody | — | — |
| Comparator | Methotrexate | Small molecule | — | — |
| Comparator | Mycophenolate Mofetil | Small molecule | — | — |
| Comparator | Pentostatin | Small molecule | — | — |
| Comparator | Rituximab | Monoclonal antibody | — | — |
| Comparator | Sirolimus | Small molecule | — | — |