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Key Points Adult patients with ETP-ALL/LBL have poor long-term outcomes. Novel therapies are urgently needed for adult patients with ETP-ALL/LBL.

We conducted a phase 1/2 study of the combination of 5-aza-2-deoxycytidine (decitabine) and the histone deacetylase inhibitor valproic acid (VPA) in patients with advanced leukemia, including older untreated patients. A group of 54 patients were treated with a fixed dose of decitabine (15 mg/m 2 by IV daily for 10 days) administered concomitantly with escalating doses of VPA orally for 10 days. A 50 mg/kg daily dose of VPA was found to be safe. Twelve (

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Background CD22 expression occurs in > 90% of patients with ALL. Inotuzumab ozogamicin, a CD22 monoclonal antibody bound to calicheamicin, is active in ALL. Methods Patients with refractory-relapsed ALL were treated with inotuzumab. The first 49 patients received single-dose inotuzumab 1.3-1.8 mg/m2 IVq 3-4 weeks.In the next 41 patients, the schedule was modified to weekly, 0.8 mg/m2 D1, 0.5mg/m2 D8 and 15, q 3-4 weeks, based on higher invitro efficacy with more frequent exposure. Results Ninety patients were treated; 68% were in salvage 2 or beyond. Overall, 17 patients (19%) achieved complete response (CR), 27 (30%) had CRp (no platelet recovery), and 8 (9%) had marrow CR (no recovery of counts), for an overall response rate of 58%. Response rates were similar single-dose and weekly dose (57% versus 59%). The median survival was 6.2 months, 5.0 months with single-dose and 7.3 months with weekly dose. Median survival was 9.2 months in Salvage 1 (37% at 1 year), 4.3 months in Salvage 2, and 6.6 months in Salvage 3 or later. The median remission duration was 7 months. Reversible bilirubin elevation, fever and hypotension were observed less frequently on the weekly dose. Allogeneic stem cell transplant (SCT) was performed 36/90 patients (40%); veno-occlusive disease was noted in 6/36 patients post SCT (17%), less frequent post weekly schedule ( 7%), and with less alkylators in preparative regimen. Conclusions Inotuzumab single-agent therapy is highly active, safe, and convenient in refractory-relapsed ALL. Weekly dose appears to be equally effective and less toxic than single-dose.