NCT00475280已完成2 期
"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients. GIMEMA Protocol LAL1104. EudraCT Code 2005-002156-17
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 32
- 主要终点
- Overall survival in Ph negative ALL patients stratified according to a geriatric assessment
研究概览
简要总结
This study aims at considering clinical heterogeneity of patients based on a "geriatric assessment" without taking into account the real age of the subject. This will allow physicians to adapt therapy according to three different groups of patients: frail, fit and intermediate and to evaluate the efficacy and feasibility of a therapy adapted to the different categories of patients.
详细描述
Treatment:
- Frail patients:
- Pretreatment with PDN
- Induction with Vinblastine and PDN
- Maintenance with MTX, 6-MP, VBL and PDN
- Fit patients:
- Pretreatment with PDN
- Induction with VCR, DNR and PDN
- Consolidation with MTX, ARA-C and G-CSF
- Autologous transplantation
- Maintenance with MTX, 6-MP, VCR, and PDN
- Intermediate patients:
- Pretreatment with PDN
- Induction with VCR, DNR and PDN
- Consolidation with MTX, ARA-C and G-CSF
- A second cycle of consolidation therapy
- Maintenance with MTX, 6-MP, VCR, and PDN
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 60 years old
- •Cytomorphologic and immunophenotypic diagnosis of ALL (all FAB groups except L3 and all immunophenotypes except SmIg+ B-ALL)
- •Signed informed consent
排除标准
- •Age <= 60 years old
- •Refuse to sign informed consent
研究组 & 干预措施
Geriatric assessment
Other
干预措施: Geriatric assessment adapted therapy (Procedure)
Geriatric assessment
Other
干预措施: Stem cells autotransplantation (Procedure)
结局指标
主要结局
Overall survival in Ph negative ALL patients stratified according to a geriatric assessment
时间窗: at 6 months from diagnosis for the Frail group of pts and at 2 years from diagnosis for the Fit and Intermediate group of patients
次要结局
- Complete Response rate(After induction therapy)
- Stem cell autotransplant feasibility(At 6 months from diagnosis)
- Incidence of adult ALL(At diagnosis)
- Evaluation of molecular, cytogenetics and immunophenotype heterogeneity in ph negative ALL patients >60(At diagnosis and during follow-up)
- Disease free survival(During follow-up)
研究者
研究点 (32)
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