Phase III Prospective Randomized Double-Blind Placebo-Controlled Trial of Plerixafor Plus Granulocyte Colony-Stimulating Factor Compared With Placebo Plus Granulocyte Colony-Stimulating Factor for Autologous Stem-Cell Mobilization and Transplantation for Patients With Non-Hodgkin's Lymphoma
Phase III Prospective Randomized Double-Blind Placebo-Controlled Trial of Plerixafor Plus Granulocyte Colony-Stimulating Factor Compared With Placebo Plus Granulocyte Colony-Stimulating Factor for Autologous Stem-Cell Mobilization and Transplantation for Patients With Non-Hodgkin's Lymphoma
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DOI：
10.1200/jco.2008.20.7209
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发表时间：
2009-10-01
影响因子：
45.3
通讯作者：
Calandra, Gary
中科院分区：
文献类型：
--
作者：
DiPersio, John F.;Micallef, Ivana N.;Calandra, Gary
本研究评价CXCR4拮抗剂普利沙福(AMD3100)动员造血干细胞用于非霍奇金淋巴瘤(NHL)患者自体干细胞移植的安全性和有效性。首次或第二次完全或部分缓解需要自体造血干细胞移植的非霍奇金淋巴瘤患者符合条件。患者每日皮下注射粒细胞集落刺激因子(G-CSF)10微克/公斤，最多8天。从第4天晚上开始，每天持续4天，患者接受普利沙福(240微克/公斤)或安慰剂皮下注射。从第5天开始，患者开始每天分离最多4天，直到收集到~gt；=5×10(6)C D34+细胞/公斤。主要终点是在4天或更少的时间内采集<5×10(6)CD34+细胞/公斤的患者的百分比。结果这份报告提供了所有患者(n=298)12个月的随访数据。普利沙福组150名患者中有89名(59%)和安慰剂组148名患者中有29名(20%)达到了主要终点(P<；.001)。普利沙福组135例(90%)和安慰剂组82例(55%)在初次动员后接受了移植。两组植入的中位时间相似。普利沙福相关不良反应最常见的是胃肠道功能紊乱和注射部位反应。结论普利沙福和G-CSF耐受性良好，导致非霍奇金淋巴瘤患者在较少的采集日内达到最佳CD34(+)细胞移植目标的比例显著高于单独使用G-CSF。
PurposeThis study evaluates the safety and efficacy of plerixafor (AMD3100), a CXCR4 antagonist, in mobilizing hematopoietic stem cells for autologous stem-cell transplantation in non-Hodgkin's lymphoma (NHL) patients.Patients and MethodsThis is a phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study. Patients with non-Hodgkin's lymphoma requiring an autologous hematopoietic stem-cell transplantation in first or second complete or partial remission were eligible. Patients received granulocyte colony-stimulating factor (G-CSF; 10 mu g/kg) subcutaneously daily for up to 8 days. Beginning on evening of day 4 and continuing daily for up to 4 days, patients received either plerixafor (240 mu g/kg) or placebo subcutaneously. Starting on day 5, patients began daily apheresis for up to 4 days or until >= 5 X 10(6)C D34+ cells/kg were collected. The primary end point was the percentage of patients who collected >= 5 X 10(6) CD34+ cells/kg in 4 or fewer apheresis days.ResultsThis report presents all data for all patients (n = 298) through 12 months follow-up. Eighty-nine (59%) of 150 patients in the plerixafor group and 29 (20%) of 148 patients in the placebo group met the primary end point (P < .001). One hundred thirty-five patients (90%) in plerixafor group and 82 patients (55%) in placebo group underwent transplantation after initial mobilization. Median time to engraftment was similar in both groups. The most common plerixafor-associated adverse events were GI disorders and injection site reactions.ConclusionPlerixafor and G-CSF were well tolerated and resulted in a significantly higher proportion of patients with non-Hodgkin's lymphoma achieving the optimal CD34(+) cell target for transplantation in fewer apheresis days, compared with G-CSF alone.