PHASE II EFFICACY STUDY OF ROFERON A (RO22-8181/002) IN HAIRY CELL LEUKEMIA

ROFERON A (RO22-8181/002) 治疗毛细胞白血病的 II 期疗效研究

• 批准号: 3853307
• 负责人: J W SMITH
• 金额: --
• 依托单位: DIVISION OF CANCER TREATMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3853307
• 关键词: antiidiotype antibody; antileukemic agent; antineoplastics; biological response modifiers; blood cell count; drug administration rate /duration; drug adverse effect; drug resistance; hairy cell leukemia; human subject; human therapy evaluation; human tissue; interferons; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy; neoplasm /cancer remission /regression

This study began as an efficacy study of interferon Alpha-2a in patients with hairy cell leukemia. It was observed that most patients responded to interferon, but that very few complete responses were being obtained. Studies being done elsewhere confirmed the low complete remission rate. Once interferon was stopped, nearly uniformly disease progression requiring reinstitution of therapy was observed. There appear to be very few if any patients who will not require further therapy after receiving 12 or 18 months of continuous interferon treatment. Because of these findings, we opted to administer interferon continuously to patients who were initially responsive to this drug. of the 53 evaluable patients (of the 56 entered on this study), there was one complete remission, 40 partial remissions, 2 minor responses, 9 patients with stable disease and only 1 patient with disease progression. In the last year, one of the patients with a minor response has now obtained a partial remission. Thirty-two patients continue to receive interferon without interruption with a median duration of continuous interferon treatment of 6.5 years. Twenty-one patients discontinued interferon for a variety of reasons, the most common being the development of acquired interferon resistance in association with interferon antibodies. The resistance to interferon was manifested early, in the first 18 months of treatment. An important finding in this study is the continued slow, but significant, hematologic improvement in absolute granulocyte and platelet counts beyond 18 months of therapy, thereby indicating that prolonged treatment results in continued benefit rather than the production of antibodies with subsequent development of interferon resistance. Although it is clear from this study that hairy cell leukemia can be controlled in the long-term with interferon, longer follow-up will be necessary to determine if continuous therapy with interferon is better than intermittent therapy.

这项研究开始于干扰素α-2a在患者中的疗效研究， 患有毛细胞白血病 据观察，大多数患者 干扰素，但获得的完全反应很少。 在其他地方进行的研究证实了完全缓解率低。 一旦停止干扰素治疗， 观察到需要重新开始治疗。 似乎有 很少有患者在治疗后不需要进一步治疗， 接受12或18个月的连续干扰素治疗。 因为 在这些发现中，我们选择持续给予干扰素， 最初对这种药物有反应的患者。在53个可评价的 患者（在本研究的56例患者中），有1例完成了 缓解，40例部分缓解，2例轻微缓解，9例 病情稳定，仅1例患者出现疾病进展。 在过去 一年来，其中一名轻微反应的患者现在已经获得了 部分缓解 32名患者继续接受干扰素治疗 无中断，持续干扰素的中位持续时间 治疗6.5年。 21例患者停用干扰素， 各种原因，最常见的是后天的发展， 与干扰素抗体相关的干扰素抗性。 的 对干扰素的耐药性在早期表现出来，在前18个月， 治疗 这项研究的一个重要发现是， 但在绝对粒细胞和 血小板计数超过18个月的治疗，从而表明， 延长治疗会持续获益，而不是 产生抗体，随后产生干扰素 阻力 虽然这项研究清楚地表明， 白血病可以用干扰素长期控制， 有必要进行随访，以确定持续治疗是否 干扰素比间歇疗法好。