ALTERNATING 2'-DCF AND RECOMBINANT LEUKOCYTE A IFN IN HAIRY CELL LEUKEMIA

交替 2-DCF 和重组白细胞 A 干扰素治疗毛细胞白血病

• 批准号: 3853299
• 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/3853299
• 关键词: antileukemic agent; antineoplastic antibiotics; antineoplastics; biopsy; blood cell count; bone marrow exam; clinical trials; combination chemotherapy; deoxycoformycin; drug adverse effect; hairy cell leukemia; human subject; human therapy evaluation; human tissue; interferons; longitudinal human study; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy; neoplasm /cancer remission /regression; antileukemic agent; antineoplastic antibiotics; antineoplastics; biopsy; blood cell count; bone marrow exam; clinical trials; combination chemotherapy; deoxycoformycin; drug adverse effect; hairy cell leukemia; human subject; human therapy evaluation; human tissue; interferons; longitudinal human study; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy; neoplasm /cancer remission /regression

We administered deoxycoformycin (dCF) and interferon-alpha (IFN-alpha) sequentially to patients with hairy cell leukemia in an attempt to improve the response rate and duration observed in earlier studies using each drug alone. Further rationale for this study included the observation that IFN-alpha resistant patients were nearly uniformally responsive to second line dCF. As there was some overlapping toxicity, we decided to administer the drugs sequentially rather than concurrently. In this study, we evaluated patients for response by performing bilateral iliac crest bone marrow biopsies and aspirates since the peripheral blood normalizes rapidly after either IFN-alpha or dCF treatment but disease becomes patchy in the bone marrow and might be missed if only unilateral bone marrow biopsies had been performed. Other studies using IFN-alpha or dCF alone used unilateral marrow examinations in evaluating response. Using these more relaxed criteria of response, authors had published high rates of complete remission to dCF. Of 15 patients entered in our study, 14 are evaluable for response with one patient having diffuse osteosclerosis not being evaluable for marrow response. All patients had rapid normalization of peripheral blood counts and all 14 marrow-evaluable patients were found to have very small numbers (less than 5% of the total marrow cellularity) of residual hairy cells at the completion of treatment. With a median follow-up now of 49 months, no patient has had an increase in the number of hairy cells in the bone marrow or any change in the peripheral blood. Although the initial response rate to the combination of dCF and interferon appears to be no better than that observed with dCF alone, the response duration may be longer. These patients continue to be followed for determination of response duration.

我们给管理脱氧霉素（DCF）和干扰素-Alpha（IFN-Alpha） 依次与毛细胞白血病患者进行 提高使用先前研究中观察到的响应率和持续时间 每种药物。 这项研究的进一步理由包括 观察到IFN-Alpha耐药患者几乎均匀 响应第二行DCF。 由于有一些重叠的毒性， 我们决定依次管理药物 同时。 在这项研究中，我们通过 进行双侧iLiac Crest骨髓活检和抽吸 由于外周血在IFN-Alpha或 DCF治疗，但疾病在骨髓中变斑，可能是 如果只进行了单方面的骨髓活检，则错过了。 单独使用IFN-Alpha或DCF的其他研究使用单侧骨髓 评估反应的考试。 使用这些更轻松的标准 作者的回应，已经发布了高度缓解率 DCF。 在我们研究中输入的15名患者中，可以评估14例 一名患有弥漫性骨硬化的患者无法评估 骨髓反应。 所有患者的外围均快速归一化 血液计数和所有14位可评估的患者均具有 非常小的数字（少于总骨髓细胞的5％） 治疗完成时残留的毛细胞。 中间 现在49个月的后续次跟进，没有病人的数量增加 骨髓中的毛细胞或外周血的任何变化。 虽然对DCF和 干扰素似乎并不比单独观察到的干扰素更好 响应持续时间可能更长。 这些患者继续是 随后确定响应持续时间。