High-dose Dexamethasone Therapy as the Initial Treatment for Idiopathic Thrombocytopenic Purpura: Protocol for a Multicenter, Open-label, Single Arm Trial

Standard therapy for idiopathic thrombocytopenic purpura (ITP) has not been established. We are conducting a multicenter, prospective trial to determine the efficacy and safety of short-term, high-dose dexamethasone therapy in ITP patients aged 18-80 years with platelet counts of <20, 000 /μL, or with <50, 000/ μL and bleeding symptoms. The primary endpoints of this trial are the proportion of responses (complete plus partial response) on day 180 (day 46+180) after the completion of the 46-day high-dose dexamethasone therapy. The results of this investigation of the effectiveness and safety of this regimen will be essential for the establishment of standard therapy for ITP

コツズイ イケイセイ ショウコウグン ユライ P39 サイボウ ニ オケル アポトーシス デワ チトクローム c オ カイサズ ライソゾーム ユライ ノ コウソ ニ ヨッテ カスペース - 3 ガ カッセイカ サレル

京都大学0048新制・課程博士博士(医学)甲第9085号医博第2393号新制||医||777(附属図書館)UT51-2001-G805京都大学大学院医学研究科内科系専攻(主査)教授 鍋島 陽一, 教授 西川 伸一, 教授 内山 卓学位規則第4条第1項該当Doctor of Medical ScienceKyoto UniversityDA

Phase II study of dose‐adjusted gemcitabine, dexamethasone, cisplatin, and rituximab in elderly relapsed diffuse large B‐cell lymphoma patients

Abstract High‐dose chemotherapy and autologous stem cell transplantation (ASCT) are too toxic for elderly patients with relapsed or refractory diffuse large B‐cell lymphoma (DLBCL). Therefore, effective and tolerable regimens for elderly patients are urgently needed. The present phase II study assessed the efficacy and safety of dose‐adjusted therapy with gemcitabine, dexamethasone, cisplatin, and rituximab (GDP‐R) in this population. ASCT‐ineligible elderly patients with relapsed or refractory DLBCL received dose‐adjusted GDP‐R in each 28‐day cycle for up to six cycles. The primary endpoint was overall response rate (ORR), and secondary endpoints were complete response (CR) rate, progression‐free survival (PFS), and safety. Thirty‐three patients were enrolled and received dose‐adjusted GDP‐R. The median age was 75 years (range: 68‐87 years). The ORR was 82.8% (90% confidence interval [CI], 67.1‐93.0%), with a CR rate of 58.6% (90% CI, 41.7‐74.1%). At a median follow‐up of 20.9 months, the 2‐year PFS rate was 46.8% (90% CI, 30.7‐61.5%) and the 2‐year overall survival rate was 63.2% (90% CI, 45.8‐76.3%). The most frequently observed grade 4 adverse events were neutropenia (63.6%), thrombocytopenia (57.6%), and lymphocytopenia (39.4%). Dose‐adjusted GDP‐R is a promising salvage regimen for ASCT‐ineligible elderly patients with relapsed DLBCL after rituximab‐containing chemotherapy and warrants further investigation