A Phase II Prospective Study of High-dose Myeloablative Therapy, With Stem Cell Devices Support in Elderly Patients (≥65 and ≤ 75 Years) With Relapsed Aggressive Non-Hodgkin Lymphoma or Resistant to First Line Therapy
试验速览
- 阶段
- 2 期
- 入组人数
- 135
- 试验地点
- 27
- 主要终点
- Event free survival EFS
研究概览
简要总结
A phase II prospective, non-randomized study. The study aim is to evaluate the feasibility and activity of high-dose therapy with stem cell in elderly patients with aggressive lymphoma relapsed FIT or resistant to first line therapy.
详细描述
The study aim is to evaluate the toxicity and activity of a therapeutic approach to high doses with support of peripheral blood stem cells (PBSC) in patients aged ≥ 65 and ≤75 years, chemosensitive relapsed or refractory to therapy first line in terms of event free survival (EFS) and treatment related mortality (TRM)
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
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of NHL
- •relapse and refractory pts
- •age ≥ 65 and ≤75
- •ECOG performance status <2
- •FIT patients (Instrumental Activity of Daily Living (IADL)=8, Activity of Daily Living (ADL)=6, Cumulative Illness Rating Scale (CIRS) =0 SCORE=3-4, <5 SCORE=2 )
- •evaluable disease
- •no RT since 3 week
- •absolute neutrophil count >= 1500/mm3 and platelets >= 100.000/106L
- •Creatinin <= 1.5 mg/dL and clearance >40 ml/min/24 h
- •bilirubins < =2 mg/dL
- •forced expiratory volume >50% - arterial pressure O2 >70 mmHg
- •no other neoplastic disease
- •Life expectancy> 3 months
- •signed informed consent
排除标准
- •HBV+ - HCV+ - HIV+
- •NSC involvement - medullar infiltration > 20%
- •other chemotherapy or radiotherapy
- •cardiac disease
- •alteration of liver and kidney function
- •infections
- •demented patient
- •no compliance and depressed pts
- •Frail and Unfit pts
研究组 & 干预措施
R-DHAP/R-ICE
High-dose myeloablative therapy (R-DHAP or R-ICE) and conditioning therapy (BEAM or FEAM) in elderly patients with relapsed NHL or resistant to firs line therapy
干预措施: R-DHAP/R-ICE (Drug)
结局指标
主要结局
Event free survival EFS
时间窗: 36 months
Evaluate the toxicity and activity of a therapeutic approach to high doses with stem cell support device (PBSC) in patients aged ≥ 65 and ≤75 years, chemosensitive relapsed or refractory to 1st line therapy in terms of EFS.
Treatment related mortality TRM
时间窗: 100 days from the high doses
Evaluate the toxicity and activity of a therapeutic approach to high doses with stem cell support device (PBSC) in patients aged ≥ 65 and ≤75 years, chemosensitive relapsed or refractory to 1st line therapy in terms of TRM.
次要结局
- Complete Remission (CR) rate(48 months (at the end of therapy))
- Overall Survival (OS)(48 months (at the end of therapy))
- Immunologic evaluation(54 months)
- Adverse events incidence evaluation (grade III or IV)(48 months (at the end of therapy))
- Quality of Life (QoL)(54 months)