PHASE II EFFICACY STUDY OF ROFERON A IN HAIRY CELL LEUKEMIA

Roferon A 治疗毛细胞白血病的 II 期疗效研究

• 批准号: 2464506
• 负责人: J E JANIK
• 金额: --
• 依托单位: DIVISION OF CLINICAL SCIENCES - NCI
• 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/2464506
• 关键词: clinical research; drug administration rate /duration; hairy cell leukemia; human subject; human therapy evaluation; interferon alpha; neoplasm /cancer immunotherapy

This study began as an efficacy study of IFN-2alpha in pts. with hairy cell leukemia. It was observed that most pts. responded to IFN, but that very few complete responses were being obtained. Studies being done elsewhere confirmed the low complete remission rate. Once IFN was stopped, nearly uniformly disease progression requiring reinstitution of therapy was observed. There appear to be very few if any pts. who will not require treatment. Because of these findings, we opted to administer IFN continuously to pts. who were initially responsive to this drug. Of the 53 evaluable pts. (of the 56 entered on this study), there was 1 complete remission, 41 partial remissions, 1 minor response, 9 pts. with stable disease and only 1 pt. with disease progression. 14 pts. continue to receive IFN without interruption with a median duration of continuous IFN treatment of 9.2 years. 34 pts. discontinued IFN for a variety of reasons, the most common being the development of acquired IFN resistance in association with IFN antibodies. The resistance to IFN was manifested early, in the first 18 months of treatment, except in 2 cases. 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 IFN resistance. Although it is clear from this study that hairy cell leukemia can be controlled in the long-term with IFN, longer follow-up will be necessary to determine if continuous therapy with IFN is better than intermittent therapy.

本研究开始时为患者中IFN-2 α的疗效研究。与毛茸茸的 细胞白血病 据观察，大多数患者。对干扰素有反应，但 得到的完整答复很少。 正在进行的研究 其他地方证实了完全缓解率低。 一旦IFN 停止，几乎一致的疾病进展，需要重新开始 治疗观察。 患者似乎很少（如果有）。谁将 不需要治疗。 由于这些发现，我们选择管理 持续给予患者IFN。最初对这种药物有反应的人 的 53名可评价患者。(of 56人参加了这项研究），有1人 完全缓解，41例部分缓解，1例轻微缓解，9例患者。与 病情稳定，仅1例患者。疾病进展。 14分。继续 不间断地接受IFN，中位持续时间为 干扰素治疗9.2年。 34例患者。中断干扰素治疗各种 原因，最常见的是获得性IFN抗性的发展 与IFN抗体联合。 对干扰素的耐药表现为 早期，在治疗的前18个月，2例病例除外。 一个 这项研究的一个重要发现是， 绝对粒细胞和血小板计数的血液学改善超过 18个月的治疗，从而表明延长治疗的结果 在持续的利益，而不是生产抗体， 随后产生IFN抗性。 虽然从这一点可以清楚地看出， 研究表明，毛细胞白血病可以长期控制， IFN，需要更长时间的随访，以确定是否继续治疗 干扰素治疗优于间歇治疗。