Phase II trial of subcutaneous anti-CD52 monoclonal antibody alemtuzumab (Campath-1H) as first-line treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL)
Phase II trial of subcutaneous anti-CD52 monoclonal antibody alemtuzumab (Campath-1H) as first-line treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL)
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DOI：
10.1182/blood-2002-01-0159
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发表时间：
2002-08-01
期刊：
影响因子：
20.3
通讯作者：
Österborg, A
中科院分区：
文献类型：
--
作者：
Lundin, J;Kimby, E;Österborg, A
这项11期研究在41例症状性B细胞慢性淋巴细胞白血病（B-CLL）患者中确定了Alemtuzumab（一种人源化抗CD 52单克隆抗体）作为一线治疗皮下给药的疗效和安全性，治疗期为18周。从第2周至第3周开始，每周皮下注射3次。38例可评价患者（意向治疗人群的81%）的总体缓解率（OR）为87%（95% CI，76%-98%;完全缓解[CR]，19%;部分缓解[PR]，68%）。95%的患者在21天的中位时间内从血液中清除了CLL细胞。66%的患者骨髓中达到CR或结节性PR，大多数患者在治疗18周后达到这一水平。在淋巴结中实现了87%的OR（29% CR）。尚未达到至治疗失败的中位时间（18+个月;范围，8-44+个月）。在90%的患者中观察到一过性注射部位皮肤反应。僵硬、皮疹、恶心、呼吸困难和低血压罕见或不存在。21%的患者发生一过性IV级中性粒细胞减少症。感染是罕见的，但10%的患者发生巨细胞病毒（CMV）再激活。这些患者对静脉注射更昔洛韦反应迅速。1例患者对复方新诺明预防性治疗过敏，发生卡氏肺孢子虫肺炎。Alemtuzumab作为B-CLL患者的一线治疗非常有效。延长治疗对最大骨髓应答很重要。皮下给药引起很少的“第一次剂量”流感样症状，并可能减少医疗保健费用相比，静脉输液。(C)2002年，美国血液学会。
This phase 11 study determined the efficacy and safety of alemtuzumab, a humanized anti-CD52 monoclonal antibody, delivered subcutaneously as first-line therapy, over a prolonged treatment period of 18 weeks in 41 patients with symptomatic B-cell chronic lymphocytic leukemia (B-CLL). Injections were administered subcutaneously 3 times per week, from week 2 to 3 onward. An overall response rate (OR) of 87% (95% Cl, 76%-98%; complete remission [CR], 19%; partial remission [PR], 68%) was achieved in 38 evaluable patients (81% of intent-to-treat population). CLL cells were cleared from blood in 95% patients in a median time of 21 days. CR or nodular PR in the bone marrow was achieved in 66% of the patients and most patients achieved this after 18 weeks of treatment. An 87% OR (29% CR) was achieved in the lymph nodes. The median time to treatment failure has not yet been reached (18+ months; range, 8-44+ months). Transient injection site skin reactions were seen in 90% of patients. Rigor, rash, nausea, dyspnea, and hypotension were rare or absent. Transient grade IV neutropenia developed in 21% of the patients. Infections were rare, but 10% patients developed cytomegalovirus (CMV) reactivation. These patients rapidly responded to intravenous ganciclovir. One patient, allergic to cotrimoxazole prophylaxis, developed Pneumocystis carinii pneumonia. Alemtuzumab is highly effective as first-line treatment in patients with B-CLL. Prolonged treatment is important for maximal bone marrow response. Subcutaneous administration induced very few "first-dose" flulike symptoms and may reduce health care costs in comparison with the intravenous infusions. (C) 2002 by The American Society of Hematology.