Phase II multicenter study of human CD52 antibody in previously treated chronic lymphocytic leukemia. European Study Group of CAMPATH-1H Treatment in Chronic Lymphocytic Leukemia.
Phase II multicenter study of human CD52 antibody in previously treated chronic lymphocytic leukemia. European Study Group of CAMPATH-1H Treatment in Chronic Lymphocytic Leukemia.
复制标题
人 CD52 抗体在既往治疗的慢性淋巴细胞白血病中的 II 期多中心研究。
DOI：
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发表时间：
1997
影响因子：
45.3
通讯作者：
H. Mellstedt
中科院分区：
文献类型：
--
作者：
A. Österborg;M. Dyer;D. Bunjes;G. Pangalis;Y. Bastion;D. Catovsky;H. Mellstedt
目的
CAMPATH-1 H是一种人免疫球蛋白G1（IgG 1）抗CD 52单克隆抗体（MA B b），可与几乎所有B和T细胞淋巴瘤和白血病结合。我们报告了一项多中心II期试验的结果，该试验在既往接受过化疗的慢性淋巴细胞白血病（CLL）患者中使用CAMPATH-1H。
材料和方法
29名在初始应答后复发（n = 8）或化疗难治性（n = 21）的患者接受了CAMPATH-1H治疗，每周3次，每次30 mg，每次2小时，静脉（IV）输注，最长持续12周。
结果
11例患者（38%）达到部分缓解（PR），1例（4%）达到完全缓解（CR）（缓解率，42%; 95%置信区间[CI]，23%至61%）。8例复发患者中有3例（38%）和21例难治性患者中有9例（43%）对CAMPATH-1H治疗有反应。29例患者中有28例（97%）的CLL细胞从血液中迅速消除。36%的患者骨髓CR，32%的患者脾肿大完全消退。仅2例患者（7%）淋巴结病正常化。中位缓解持续时间为12个月（范围：6至25+）。分别有3名（10%）和2名（7%）患者发生了世界卫生组织（WHO）IV级中性粒细胞减少和血小板减少。在继续CAMPATH-1H治疗期间，大多数有反应的患者的中性粒细胞减少症和血小板减少症均恢复。所有患者均出现淋巴细胞减少症（< 0.5 × 10（9）/L）。2例患者有机会性感染，4例有细菌性败血症。
结论
CAMPATH-1H在晚期和化疗耐药CLL患者中具有显著活性。在血液、骨髓和脾脏中观察到最明显的影响。优先清除血液可能允许收获未污染的造血干细胞用于高剂量化疗方案。
PURPOSE
CAMPATH-1H is a human immunoglobulin G1 (IgG1) anti-CD52 monoclonal antibody (MAb) that binds to nearly all B- and T-cell lymphomas and leukemias. We report the results of a multicenter phase II trial that used CAMPATH-1H in previously chemotherapy-treated patients with chronic lymphocytic leukemia (CLL).
MATERIALS AND METHODS
Twenty-nine patients who had relapsed after an initial response (n = 8) or were refractory (n = 21) to chemotherapy were treated with CAMPATH-1H administered as a 30-mg 2-hour intravenous (IV) infusion thrice weekly for a maximum period of 12 weeks.
RESULTS
Eleven patients (38%) achieved a partial remission (PR) and one (4%) a complete remission (CR) (response rate, 42%; 95% confidence interval [CI], 23% to 61%). Three of eight patients (38%) with a relapse and nine of 21 refractory patients (43%) responded to CAMPATH-1H therapy. CLL cells were rapidly eliminated from blood in 28 of 29 patients (97%). CR in the bone marrow was obtained in 36% and splenomegaly resolved completely in 32%. Lymphadenopathy was normalized in only two patients (7%). The median response duration was 12 months (range, 6 to 25+). World Health Organization (WHO) grade IV neutropenia and thrombocytopenia developed in three (10%) and two patients (7%), respectively. Neutropenia and thrombocytopenia recovered in most responding patients during continued CAMPATH-1H treatment. Lymphopenia (< 0.5 x 10(9)/L) occurred in all patients. Two patients had opportunistic infections and four had bacterial septicemia.
CONCLUSION
CAMPATH-1H had significant activity in patients with advanced and chemotherapy-resistant CLL. The most pronounced effects were noted in blood, bone marrow, and spleen. Preferential clearance of blood may allow harvesting of uncontaminated blood stem cells for use in high-dose chemotherapy protocols.
氟达拉滨：一种对慢性淋巴细胞白血病具有主要活性的新药。
影响因子：
20.3
作者：
Keating,MJ;Kantarjian,H;Talpaz,M;Redman,J;Koller,C;Barlogie,B;Velasquez,W;Plunkett,W;Freireich,EJ;McCredie,KB
通讯作者：
McCredie,KB