Use of a Response-Adapted Ruxolitinib-Containing Regimen for the Treatment of Hemophagocytic Lymphohistiocytosis (HLHRUXO)
Study ID: STU-2023-0217
Summary
This study is a multi-site Phase ib/ii, 2-arm (Frontline and Salvage) nonrandomized clinical trial to determine the efficacy and tolerability of a response-adapted regimen combining ruxolitinib, dexamethasone, and etoposide for patients with newly diagnosed or relapsed/refractory hemophagocytic lymphohistiocytosis (HLH). Primary endpoints are: * Complete response (CR/CRi) after 8 weeks of therapy. * adverse events (aes) associated with the ruxolitinib-containing regimen.
The primary objective is to determine the efficacy and tolerability of a response-adapted ruxolitinib-containing regimen for patients with newly diagnosed HLH. Secondary objectives include: 1. To describe the efficacy and tolerability of a response-adapted ruxolitinib-containing regimen for patients with relapsed/refractory HLH. 2. To describe the overall response and outcome for patients with newly diagnosed or relapsed/refractory HLH who are treated with this response-adapted ruxolitinib-containing regimen.