Department of Leukemia, The University of Texas M. D. Anderson Cancer Center, Houston, TX, USA.
Blood. 2011 Oct 6;118(14):3818-23. doi: 10.1182/blood-2011-04-351502. Epub 2011 Aug 5.
We conducted this study to determine the feasibility and safety of cladribine followed by rituximab in patients with hairy cell leukemia including the vari-ant form (HCLv). Cladribine 5.6 mg/m² given IV over 2 hours daily for 5 days was followed ∼ 1 month later with rituximab 375 mg/m² IV weekly for 8 weeks. Responses were recorded and BM minimal residual disease (MRD) was evaluated after the completion of rituximab. Thirty-six patients have been treated including 5 with HCLv. Median age was 57 years (range, 37-89). All patients (100%) have achieved complete response (CR), defined as presence of no hairy cells in BM and blood with normalization of counts (absolute neutrophil count [ANC]> 1.5 × 10⁹/L, hemoglobin [Hgb] > 12.0 g/dL, platelets [PLT] > 100 × 10⁹/L), as well as resolution of splenomegaly. There were no grade 3 or 4 nonhematologic adverse events directly related to the treatment. Only 1 patient (with HCLv) has relapsed; median CR duration has not been reached (range,1+-63+ months). Three patients with HCLv died including 1 with relapsed disease and 2 from unrelated malignancies. Median survival duration has not been reached (range, 2+-64+ months). Treatment with cladribine followed by rituximab is effective tk;4and may increase CR rate. This study was registered at www.clinicaltrials.gov as NCT00412594.
我们进行这项研究，旨在确定克拉屈滨联合利妥昔单抗在包括变异型（HCLv）在内的毛细胞白血病患者中的可行性和安全性。克拉屈滨 5.6mg/m² 静脉滴注，每日 2 小时，连用 5 天，约 1 个月后给予利妥昔单抗 375mg/m² 静脉滴注，每周 1 次，连用 8 周。记录反应，并用完成利妥昔单抗后评估骨髓微小残留病（MRD）。共治疗了 36 例患者，其中 5 例为 HCLv。中位年龄为 57 岁（范围，37-89）。所有患者（100%）均达到完全缓解（CR），定义为骨髓和血液中无毛细胞，计数正常（绝对中性粒细胞计数[ANC]＞1.5×10⁹/L，血红蛋白[Hgb]＞12.0g/dL，血小板[PLT]＞100×10⁹/L），以及脾肿大消退。无与治疗直接相关的 3 级或 4 级非血液学不良事件。仅 1 例（HCLv）患者复发；CR 持续时间未达到（范围，1+-63+个月）。3 例 HCLv 患者死亡，其中 1 例疾病复发，2 例死于非相关恶性肿瘤。中位生存时间未达到（范围，2+-64+个月）。克拉屈滨联合利妥昔单抗治疗有效，可能增加 CR 率。该研究在 www.clinicaltrials.gov 上注册为 NCT00412594。
