NCT01376427Unknown不适用
PROTOCOL TREATMENT for Acute Lymphoblastic Leukemia Ph '(BCR / ABL) POSITIVE PATIENTS AGED> 55 YEARS
PETHEMA Foundation1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy in terms of response rate
研究概览
简要总结
This study proposes to provide adequate treatment and is based on current scientific evidence for elderly patients with ALL Bcr / Abl positive.
To determine whether low-dose chemotherapy associated with imatinib or dasatinib has acceptable tolerability in elderly patients.
To determine whether this association can increase the rate and quality of referrals to the results of the literature of imatinib as monotherapy for elderly patients
详细描述
Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day EV for 5 days (-5 to -1).
Intrathecal treatment (diagnosis and prophylactic / therapeutic) -5 days:
Methotrexate 12 mg
Systemic treatment:
- Imatinib 400 mg daily and continuous VO.
- Vincristine (VCR) 1 mg (absolute dose) EV 1, 8, 15 and 22.
- Dexamethasone (DEX): 10 mg/m2 EV, IM or PO days 1-2, 8-9 days 15-16, 22-23. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'positive (Bcr / Abl positive) and previously untreated
排除标准
- •Other LAL negative for t (9; 22) and Bcr / Abl.
- •biphenotypic acute leukemias or bilinear with t (9; 22).
- •blast crisis of chronic myeloid leukemia progression during or after polychemotherapy treatment (including allo-BMT) or with inhibitors of tyrosine kinases.
- •The criteria for exclusion from treatment (but not patient record) any of the following
- •General condition affected (grades 3 and 4 WHO scale), not attributable to the LAL.
- •Lack of consent by the patient to use their clinical d
结局指标
主要结局
Efficacy in terms of response rate
时间窗: 5 years
次要结局
- Number of Participants with Adverse Events treated with chemotherapy and dasatinib combination(1 year)
研究者
研究点 (1)
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