EFFICACY STUDY OF RECOMBINANT LEUKOCYTE A IFN IN HAIRY CELL LEUKEMIA

重组白细胞A干扰素治疗毛细胞白血病的疗效研究

• 批准号: 3939598
• 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/3939598
• 关键词: antileukemic agent; antineoplastics; drug adverse effect; hairy cell leukemia; human subject; human therapy evaluation; human tissue; immunotherapy; interferons; neoplasm /cancer chemotherapy

This study is an old but ongoing study evaluating the efficacy of recombinant alpha interferon in patients with hairy cell leukemia. Fifty-six patients have been admitted to this study and of these 43 continue on therapy. The overall initial response rate was 92 percent of 54 patients evaluable for response. There have been 2 complete responses, 33 partial responses, 15 minor responses, and 4 patients did not respond. Two patients are not evaluable for hematologic response. One received only a single dose of interferon prior to the discovery of a malignant glioma, and the second patient is not evaluable for hematologic response because she was treated for painful bony involvement proven to be due to hairy cells. One patient who did not respond at 3 million units daily was dose escalated to 6 million units daily and subsequently had a minor response which is ongoing. Seven patients who responded initially ultimately had disease progression. Six of these were treated with higher doses of interferon and 3 have responded. The response in these 3 patients however has been limited and transient. Forty-three responding patients continue to respond. Toxicity has been minimal and acceptable. The most common side effect has been minor fatigue which in no way has been limiting.

这项研究是一项古老但正在进行的研究，评估 重组α干扰素在毛细胞白血病患者中的应用。 56名患者被纳入这项研究，其中 43人继续接受治疗。总体初步应答率为92 54名患者中有5%的患者可评估疗效。已经有2次了 完整回复，33个部分回复，15个次要回复，以及 4例无反应。两名患者不能进行评估 血液学反应。其中一人只接受了一剂 在发现恶性胶质瘤之前使用干扰素，以及 第二个患者的血液学反应是不可评估的，因为 她因疼痛的骨质牵连而接受治疗，证实是由于 毛细胞。一名患者在300万单位时没有反应 每天的剂量增加到每天600万个单位，随后 有一个轻微的反应，正在进行中。七名患者 最初的反应最终是疾病的进展。其中六个 这些人接受了更高剂量的干扰素治疗，其中3人 有回应。然而，这3名患者的反应是 有限的和短暂的。43名有反应的患者继续 来回应。 毒性很小，可以接受。最常见的 副作用是轻微的疲劳，而这绝不是 限制。