POG 9421--STANDARD VS HIGH DOSE ARA-C INDUCTION FOLLOWED BY CYCLOSPORINE

POG 9421--标准与高剂量 ARA-C 诱导（随后使用环孢素）

• 批准号: 6120826
• 负责人: HOLCOMBE GRIER
• 金额: $ 3.04万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6120826
• 关键词: acute myelogenous leukemia; blood disorder chemotherapy; bone marrow transplantation; child (0-11); clinical research; combination chemotherapy; cyclosporines; cytogenetics; cytosine arabinoside; dosage; gene induction /repression; homologous transplantation; human genetic material tag; human subject; human therapy evaluation; multidrug resistance; neoplasm /cancer chemotherapy; neoplasm /cancer remission /regression; pediatric neoplasm /cancer; phenotype; prognosis

This is a Pediatric Oncology Group (POG) Phase III acute myelogeneous leukemia (AML) study. The study will investigate whether the use of cyclosporine and high dose Ara-C in induction improves outcome in childhood AML, and whether reversal of the multidrug resistance (MDR) phenotype using cyclosporine during remission improves survival. Specific Aims: 1) Determine the effect of high dose vs standard dose Ara-C induction on Cancer remission and event free survival (EFS) in childhood AML 2) Compare the EFS in childhood AML after 3 cycles of consolidation with or without the MDR modulator, Cyclosporine A. 3) Compare the EFS between patients genetically randomized between allogeneic BMT and chemotherapy. 4) Evaluate the impact on EFS of various clinical and laboratory factors such as cytogenetics and MDR expression.

这是儿科肿瘤学组 (POG) III 期急性骨髓性 白血病（AML）研究。该研究将调查是否使用 环孢素和高剂量 Ara-C 诱导可改善预后 儿童 AML 以及是否逆转多药耐药性 (MDR) 缓解期间使用环孢素的表型可提高生存率。 具体目标： 1) 确定高剂量与标准剂量 Ara-C 诱导的效果 儿童 AML 的癌症缓解和无事件生存 (EFS) 2) 比较 3 个巩固周期后儿童 AML 的 EFS 与 或不使用 MDR 调节剂环孢菌素 A。 3) 比较基因随机化患者之间的 EFS 同种异体 BMT 和化疗。 4) 评估各种临床和实验室因素对EFS的影响 例如细胞遗传学和 MDR 表达。