Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction and Post-remission Chemotherapy in Older Patients With Acute Myeloid Leukaemia, and Feasibility of Allogeneic Transplantation for Patients From 60 to 65 Years Old
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 459
- 试验地点
- 32
- 主要终点
- Overall Survival
研究概览
简要总结
A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5 + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in complete remission (CR) will then receive a post-remission schedule with or without lomustine according to randomization. Patients from 60 to 65 years old will be proposed to reduced conditioning allogeneic transplantation after first consolidation.
详细描述
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Principal Objective: The primary objective of this study is to assess the ability of lomustine to increase the overall survival by adding lomustine to induction and post-remission chemotherapy.
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Secondary Objectives:
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To assess the ability of lomustine to increase the CR rate.
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To assess the ability of lomustine to increase the event-free survival.
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To evaluate the toxicity and side-effects of lomustine.
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To evaluate the feasibility of reduced conditioning allogeneic transplantation *between 60 and 65 years old.
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To evaluate prognostic factors.
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To evaluate QOL in elderly.
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Study design: Parallel
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Study plan:
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Induction therapy: Patients will be randomized to receive idarubicin (5d) plus cytarabine or the same drugs plus lomustine, the latter given at the dose of 200 mg/m2 orally at day 1.
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Consolidation therapy: After completing induction treatment, patients who are in complete remission will receive a course of consolidation therapy with idarubicin (3d) and subcutaneous cytarabine.
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Maintenance therapy: In all patients with persisting CR one month after completing consolidation: six courses of monthly combination chemotherapy (idarubicin (1d) and subcutaneous cytarabine) and then a continuous regimen of methotrexate and 6-mercaptopurine, for 6 months.
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Allogeneic transplantation: Patients between 60 and 65 years old with a full matched donor will receive after consolidation (if still in CR) an alloBMT with a reduced conditioning regimen of Fludarabine (3d) and TBI (2Gy).
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Number of subjects: 460
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 60 years and older with de novo AML and non-poor cytogenetic features.
- •Patients with no unfavourable cytogenetic (based on GOELAMS-BGMT criteria)
- •Performance status and Sorror score < 3 .
- •Signed and dated informed consent.
排除标准
- •Acute promyelocytic leukemia.
- •Patients with myeloproliferative syndromes prior to diagnosis of AML.
- •Patients who previously had myelodysplastic syndrome.
- •Positive serology for HIV.
- •Patients with unfavourable cytogenetic
- •Patients with an isolated medullary extra localization of their disease
研究组 & 干预措施
1
Patients will be treated by adding lomustine to chemotherapy
干预措施: Lomustine (Drug)
结局指标
主要结局
Overall Survival
时间窗: 1 year
次要结局
- Complete remission(1 year)
- Event-free survival(1 year)
- Prognostic factors(1 year)
- Quality of Life (QOL)(1 year)