Angiolillo Anne L, Yu Alice L, Reaman Gregory, Ingle Ashish M, Secola Rita, Adamson Peter C
Division of Oncology, Children's National Medical Center, Washington, District of Columbia 20010, USA.
Pediatr Blood Cancer. 2009 Dec;53(6):978-83. doi: 10.1002/pbc.22209.
Despite the increasing cure rates for children with acute lymphoblastic leukemia (ALL), patients who relapse continue to have poor prognosis. The Children's Oncology Group (COG) conducted a limited institution Phase II trial of Campath-1H, a monoclonal antibody that targets CD52 on leukemic cells, in children with relapsed or refractory ALL.
From October 2005 to December 2006, 13 eligible patients were enrolled on the COG phase II study of Campath-1H (ADVL0222). Campath-1H was initially administered as an intravenous infusion over 2 hr, five times per week for 1 week, then three times per week for three additional weeks. Patients with stable disease or better on day 29 could continue on to combination therapy with Campath-1H, methotrexate, and 6-mercaptopurine for two additional cycles.
One of 13 patients enrolled had a complete response to Campath-1H and 4 had stable disease. Dose limiting toxicity occurred in two out of nine fully evaluable patients (Grade IV pain and Grade III allergic reaction/hypersensitivity). No patients received combination therapy. Serum Campath-1H concentrations appeared to be somewhat lower in children with ALL compared with adult patients with chronic lymphocytic leukemia.
Although a single complete response was observed, activity of single agent Campath-1H appears limited. Our study does not support future single agent evaluation of Campath-1H in children with relapsed ALL.
尽管急性淋巴细胞白血病（ALL）患儿的治愈率不断提高，但复发患者的预后仍然很差。儿童肿瘤学组（COG）对Campath-1H进行了一项机构有限的II期试验，Campath-1H是一种靶向白血病细胞上CD52的单克隆抗体，用于复发或难治性ALL患儿。
2005年10月至2006年12月，13名符合条件的患者参加了COG关于Campath-1H的II期研究（ADVL0222）。Campath-1H最初以静脉输注的方式给药，持续2小时，每周5次，共1周，然后每周3次，再持续3周。在第29天病情稳定或好转的患者可以继续接受Campath-1H、甲氨蝶呤和6-巯基嘌呤的联合治疗，再进行两个周期。
13名入组患者中有1名对Campath-1H完全缓解，4名病情稳定。9名可进行全面评估的患者中有2名出现剂量限制性毒性（IV级疼痛和III级过敏反应/超敏反应）。没有患者接受联合治疗。与成人慢性淋巴细胞白血病患者相比，ALL患儿的血清Campath-1H浓度似乎略低。
尽管观察到1例完全缓解，但单药Campath-1H的活性似乎有限。我们的研究不支持未来对复发ALL患儿进行Campath-1H单药评估。
