Department of Internal Medicine-Hematology and Oncology, University Hospital Brno, Brno, Czech Republic; Central European Institute of Technology (CEITEC), Masaryk University Brno, Brno, Czech Republic.
Am J Hematol. 2015 May;90(5):417-21. doi: 10.1002/ajh.23964. Epub 2015 Apr 1.
The treatment of relapsed/refractory chronic lymphocytic leukemia (CLL) remains a challenging clinical issue. An important treatment option is the use of high-dose corticosteroids. The purpose of this clinical trial was to determine the efficacy and toxicity of an ofatumumab-dexamethasone (O-Dex) combination in relapsed or refractory CLL. The trial was an open-label, multicenter, nonrandomized, Phase II study. The O-Dex regimen consisted of intravenous ofatumumab (Cycle 1: 300 mg on day 1, 2,000 mg on days 8, 15, and 22; Cycles 2-6: 1,000 mg on days 1, 8, 15, and 22) and oral dexamethasone (40 mg on days 1-4 and 15-18; Cycles 1-6). The O-Dex regimen was given until best response, or a maximum of six cycles. Thirty-three patients (pts) were recruited. Twenty-four (73%) pts completed at least three cycles of therapy. The remaining nine pts were prematurely discontinued owing to Grade 3/4 infections (seven pts), disease progression (one pt), or uncontrollable diabetes mellitus (one pt). Overall response rates/complete remissions (ORR/CR) were achieved in 22/5 pts (67/15%). The median progression-free survival (PFS) was 10 months. In pts with p53 defects (n = 8), ORR/CR were achieved in 5/2 pts (63/25%) with a median PFS of 10.5 months. The median overall survival (OS) was 34 months. The Grades 3-5 infectious toxicity in 33% of pts represented the most frequent side effect during the treatment period. In conclusion, the O-Dex regimen shows a relatively high ORR and CR with promising findings for PFS and OS. The study was registered at www.clinicaltrials.gov (NCT01310101).
复发/难治性慢性淋巴细胞白血病 (CLL) 的治疗仍然是一个具有挑战性的临床问题。一种重要的治疗选择是使用高剂量皮质类固醇。本临床试验的目的是确定奥法木单抗-地塞米松 (O-Dex) 联合治疗复发或难治性 CLL 的疗效和毒性。该试验为开放标签、多中心、非随机、II 期研究。O-Dex 方案包括静脉注射奥法木单抗（第 1 周期：第 1、2 天 300mg，第 8、15 和 22 天 2000mg；第 2-6 周期：第 1、8、15 和 22 天 1000mg）和口服地塞米松（第 1-4 天和第 15-18 天 40mg；第 1-6 周期）。O-Dex 方案一直用到最佳反应或最多 6 个周期。共招募了 33 名患者（pts）。24 名（73%）pts 至少完成了三个周期的治疗。其余 9 名 pts 因 3/4 级感染（7 名 pts）、疾病进展（1 名 pts）或无法控制的糖尿病（1 名 pts）提前停药。5 名/5 名（67/15%）pts 达到总缓解率/完全缓解率（ORR/CR）。中位无进展生存期（PFS）为 10 个月。在有 p53 缺陷的 pts 中（n=8），2 名/2 名（63/25%）达到 ORR/CR，中位 PFS 为 10.5 个月。中位总生存期（OS）为 34 个月。33%的 pts 出现 3-5 级感染毒性，是治疗期间最常见的副作用。总之，O-Dex 方案显示出相对较高的 ORR 和 CR，并有希望改善 PFS 和 OS。该研究在 www.clinicaltrials.gov（NCT01310101）注册。
