A randomized, multicenter phase II trial to compare prophylaxis of graft versus host disease with tacrolimus and mycophenolate mofetil versus ruxolitinib after post-transplant cyclophosphamide.
Transplant Cell TherApr 30, 2026 (epub)
I Moiseev, Mikhail Drokov, Yulia Kitaeva et al.
✦ AI-curated · Sources linked
In 30 seconds
This multicenter phase II randomized trial evaluated the efficacy and safety of PTCy-Ruxo versus PTCy-Tac-MMF for GVHD prophylaxis in 128 adults with acute myeloid or lymphoblastic leukemia post-HCT. The study found that PTCy-Ruxo demonstrated noninferior efficacy with a cumulative incidence of acute GVHD grade II-IV at 125 days of 12.9% compared to 21.2% for PTCy-Tac-MMF, meeting the noninferiority margin.
Key findings
- Cumulative incidence of acute GVHD grade II-IV was 12.9% for PTCy-Ruxo versus 21.2% for PTCy-Tac-MMF.
- PTCy-Ruxo showed a risk difference of -8.3% for acute GVHD II-IV.
- Moderate and severe chronic GVHD incidence was 24.2% for PTCy-Ruxo compared to 39.5% for PTCy-Tac-MMF.
- PTCy-Ruxo was associated with reduced acute kidney injury (1.6% vs 12.1%) and endothelial complications (1.6% vs 13.6%).
Why it matters
The findings suggest that PTCy-Ruxo may provide a safer alternative to traditional calcineurin-based regimens for GVHD prophylaxis in allogeneic HCT, potentially improving patient outcomes and reducing complications.