NCT00784537已完成2 期
Early Salvage With High Dose Chemotherapy and Stem Cell Transplantation in Advanced Stage Hodgkin's Lymphoma Patients With Positive PET After Two Courses of ABVD (PET-2 Positive) and Comparison of RT Versus no RT in PET-2 Negative Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 27
- 主要终点
- To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue.
研究概览
简要总结
The purpose of this study is to define an improvement in patients:
- To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue
- To analyse if patients achieving early complete response (PET-2 negative), can be spared the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned six courses of ABVD. To answer this question, PET-2 negative patients will be randomized between radiotherapy versus no radiotherapy at the end of ABVD therapy.
详细描述
This study is composed by two phases:
- A phase II multi-centre study evaluating in patients with advanced stage Hodgkin lymphoma the efficacy of an early salvage treatment with high-dose chemotherapy followed by stem cell transplantation in patients FDG-PET positive after two courses of ABVD (PET-2 positive).
- A phase III randomised study comparing the efficacy of radiotherapy to the areas of initial bulky disease versus no further therapy in PET-2 negative patients in complete remission (PET-6 negative) at the end of six courses of ABVD.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed Hodgkin's lymphoma of the classical type (nodular lymphocyte predominance excluded).
- •Stage IIB-IV.
- •No prior therapy for Hodgkin's lymphoma
- •Written informed consent.
- •ECOG performance status grades 0-3 (see Appendix E).
- •FDG-PET scan before the initiation of treatment.
排除标准
- •Prior therapy for Hodgkin's lymphoma.
- •Age less than 18 or more than
- •Other concomitant or prior malignancies, except basal cell skin carcinoma, or adequately treated carcinoma in situ of the cervix, or any cancer in complete remission for more than 5 years.
- •HIV infection.
- •Pregnancy or breast-feeding.
- •Renal failure (creatinine ≥2 times the normal value), liver failure (AST/ALT or bilirubine ≥ 2.5 times the normal value) or heart failure (NYHA class ≥ 2 or FEV < 45%).
研究组 & 干预措施
Arm A
Other
Two courses of ABVD. Early restaging with FDG-PET scan (PET-2)
The subsequent treatment will be as it follows:
- PET-2 positive patients will be high-dose salvage treatment;
- PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses).
The following restaging procedures are planned as it follows:
- Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan.
- Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6).
PET-6 negative patients will be randomized to first arm:
No radiotherapy.
干预措施: ABVD (Drug)
Arm B
Other
Two courses of ABVD. Early restaging with FDG-PET scan (PET-2)
The subsequent treatment will be as it follows:
- PET-2 positive patients will be high-dose salvage treatment;
- PET-2 negative patients will be treated with four additional courses of ABVD (for a total of six courses).
The following restaging procedures are planned as it follows:
- Optional: Whole body CT scan after the fourth course of ABVD; no therapy change will be made according to CT scan.
- Mandatory: Whole body CT and FDG-PET scans after the sixth course of ABVD (PET-6).
PET-6 negative patients will be randomized to second arm:
Adjuvant radiotherapy (30 Gy) on sites of initial bulky disease.
干预措施: ABVD and Radiotherapy (Drug)
结局指标
主要结局
To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue.
时间窗: 4 years
次要结局
- To analyse if patients achieving early complete response (PET-2 negative), can be spared the adjuvant radiotherapy on areas of initial bulky disease, at the end of the planned six courses of ABVD.(4 years)
研究者
研究点 (27)
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