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: 3874527
• 负责人: R G STEIS
• 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/3874527
• 关键词: antiidiotype antibody; antileukemic agent; antineoplastics; biological response modifiers; drug administration rate /duration; drug adverse effect; hairy cell leukemia; human subject; human therapy evaluation; human tissue; immunotherapy; interferons; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy

This study began as an efficacy study of interferon alfa-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 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, 34 partial remissions, 3 minor responses, 9 patients with stable disease and only 1 patient with disease progression. Thirty-two patients continue to receive interferon without interruption with a median duration of continuous interferon treatment of 60 months. Twenty-one patients discontinued interferon for a variety of reasons the most common of which being the development of acquired interferon resistance in association with interferon antibodies. Although it is clear from this study that the disease can be controlled in the long-term with interferon, longer follow-up will be necessary to determine if this form of therapy is better than intermittent therapy with interferon.

这项研究始于干扰素α-2a对患者的疗效研究。 患有毛细胞白血病。据观察，大多数患者对 干扰素，但获得的完全应答很少。 在其他地方进行的研究证实了低的完全缓解率。 一旦干扰素停止，几乎一致的疾病进展需要 观察治疗改制情况。如果有的话，似乎也很少。 在12或18个月后不需要进一步治疗的患者 持续的干扰素治疗。由于这些发现，我们选择了 对最初感染的患者持续使用干扰素 对这种药物有反应。在53名可评估的患者中(56名进入 在这项研究中)，完全缓解1例，部分缓解34例，3例 轻微反应，9例病情稳定，仅1例 疾病的发展。32名患者继续接受干扰素治疗 无中断，持续时间中位数为干扰素 治疗60个月。21例患者停用干扰素一年 原因多种多样，其中最常见的是 获得性干扰素抵抗与干扰素抗体相关。 尽管从这项研究中可以清楚地看出，这种疾病可以在 长期使用干扰素，需要较长时间的随访 确定这种形式的治疗是否比间歇治疗更好 干扰素。