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A phase III randomized trial (NCT04838704) investigated the efficacy of the addition of low-dose RUX to cyclosporin + MTX vs MMF + CsA + MTX for the prevention of aGvHD post haplo-HSCT.1 Results from the trial were presented by Yanmin Zhao at the 66th ASH Annual Meeting and Exposition.1 |
Key learnings |
The incidence of Grade 2–4 aGvHD was lower in the RUX + CsA + MTX arm vs the MMF + CsA + MTX arm (7.8% vs 36.9%, p < 0.001); MVA also showed a lower incidence of Grade 2–4 aGvHD at Day 100 (HR, 6.07). |
RUX + CsA + MTX vs MMF + CsA + MTX showed lower incidence of Grade 2–4 aGvHD at Day 180 (12.6% vs 38.8%, p < 0.001) and moderate-to-severe cGvHD (3.3% vs 19.6%, p = 0.006). |
Patients in the RUX + CsA + MTX arm had higher 3-year GRFS (76.5% vs 54.2%, p = 0.00014) and lower 3-year NRM (NR vs 6.0%, p = 0.014) than those in the MMF + CsA + MTX arm. |
Based on the findings, low-dose RUX significantly reduced the incidence of both Grade 2–4 aGvHD and moderate-to-severe cGvHD. |
Abbreviations: aGvHD, acute graft-versus-host disease; cGvHD, chronic graft-versus-host disease; CsA, cyclosporin A; GRFS, graft-versus-host disease relapse-free survival; HR, hazard ratio; MMF, mycophenolate mofetil; MTX, methotrexate; MVA, multivariate analysis; NR, not reached; NRM, non-relapse mortality, RUX, ruxolitinib.
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