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A phase II Japanese trial of fludarabine, cyclophosphamide and rituximab for previously untreated chronic lymphocytic leukemia.

日本一项氟达拉滨、环磷酰胺和利妥昔单抗治疗既往未经治疗的慢性淋巴细胞白血病的II期试验。

  • 影响因子:2.04
  • DOI:10.1093/jjco/hyaa215
  • 作者列表:"Izutsu K","Kinoshita T","Takizawa J","Fukuhara S","Yamamoto G","Ohashi Y","Suzumiya J","Tobinai K
  • 发表时间:2021-03-03
Abstract

OBJECTIVE:Fludarabine, cyclophosphamide and rituximab (FCR) is the standard regimen for fit patients with untreated CD20-positive chronic lymphocytic leukemia (CLL). However, this combination is unavailable in Japan because rituximab is not approved for CLL. We investigated the efficacy and safety of FCR in this single-arm, multicenter study designed as a bridging study to the CLL8 study by the German CLL Study Group. METHODS:The study enrolled previously untreated patients with CLL of Binet stage B or C with active disease. Patients with a Cumulative Illness Rating Scale score of ≤6 and creatinine clearance of ≥70 ml/min were eligible. Patients received 6 cycles of FCR every 28 days and were followed for up to 1 year. RESULTS:Seven patients were enrolled. The best overall response rate according to the 1996 NCI-WG Guidelines, the primary endpoint of the study, was 71.4% (95% confidence interval, 29.0-96.3%), with one patient achieving complete response. No deaths or progression occurred during follow-up. The main adverse event was hematotoxicity. CD4-positive T-cell count decreased in all patients; most patients showed no reduction in serum immunoglobulin G. CONCLUSION:Although the number of patients was limited, FCR appears to be effective with manageable toxicity for treatment-naïve fit Japanese patients with CD20-positive CLL. CLINICAL TRIAL NUMBER:JapicCTI-132285.

摘要

目的: 氟达拉滨、环磷酰胺和利妥昔单抗 (FCR) 是治疗CD20-positive慢性淋巴细胞白血病 (CLL) 的标准方案。然而,该组合在日本不可用,因为利妥昔单抗未被批准用于CLL。我们在这项由德国CLL研究组设计为CLL8研究的桥接研究的单臂多中心研究中调查了FCR的疗效和安全性。 方法: 本研究纳入了既往未经治疗的Binet B期或C期CLL患者,并伴有活动性疾病。累积病情评定量表评分 ≤ 6分、肌酐清除率 ≥ 70毫升/min的患者符合入选条件。患者每28天接受6个周期的FCR,随访长达1年。 结果: 7例患者入选。根据1996 nci-wg指南 (研究的主要终点),最佳总体缓解率为71.4% (95% 置信区间,29.0-96.3%),1例患者达到完全缓解。随访期间未发生死亡或进展。主要不良事件为血液毒性。所有患者中CD4-positive的T细胞计数降低; 大多数患者显示血清免疫球蛋白G没有降低。 结论: 尽管患者数量有限,但FCR似乎对CD20-positive CLL的日本初治患者有效,毒性可控。 临床试验编号: JapicCTI-132285。

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