NCT00275106终止3 期
Treatment Protocol for T-Cell and B-Precursor Cell Lymphoblastic Lymphoma of the European Inter-group Co-operation on Childhood Non-Hodgkin-Lymphoma (EICNHL)
Children's Cancer and Leukaemia Group43 个研究点 分布在 3 个国家目标入组 600 人开始时间: 2004年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 600
- 试验地点
- 43
- 主要终点
- Conditional event-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as prednisolone and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known whether prednisolone is more effective than dexamethasone when given together with combination chemotherapy in treating lymphoblastic lymphoma.
PURPOSE: This phase III randomized clinical trial is studying prednisolone to see how well it works compared to dexamethasone when given together with combination chemotherapy in treating young patients with newly diagnosed lymphoblastic lymphoma.
详细描述
OBJECTIVES:
Primary
- Compare the event-free survival of young patients with newly diagnosed lymphoblastic lymphoma treated with induction prednisolone vs dexamethasone.
- Compare the safety of standard maintenance treatment over 18 months vs 24 months in these patients.
Secondary
- Determine prognostic factors highly predicative for treatment failure in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed lymphoblastic lymphoma (LBL)
- •Stage I-IV disease
- •T-cell LBL, precursor B-cell LBL, or LBL with an unknown immunophenotype
- •PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •No known HIV or AIDS infection
- •No severe immunodeficiency
- •No other prior malignancy
- •No prior disease that would preclude treatment with chemotherapy
- •PRIOR CONCURRENT THERAPY:
- •More than 2 months since prior systemic corticosteroids for a duration of > 8 days
- •No prior chemotherapy
- •No prior radiotherapy
- •No prior organ transplant
- •No trimethoprim-sulfamethoxazole 6 days before or during methotrexate therapy
- •No concurrent participation in another clinical trial
排除标准
- 未提供
结局指标
主要结局
Conditional event-free survival
次要结局
- Overall survival
- Acute and long-term toxicity
- Non-lymphoma-related deaths and early deaths (excluding deaths occurring after second line treatment for failure or relapse)
研究者
研究点 (43)
Loading locations...
相似试验
已完成
3 期
Combination Chemotherapy in Treating Patients With Multiple MyelomaMultiple Myeloma and Plasma Cell NeoplasmNCT00002678NCIC Clinical Trials Group595
已完成
3 期
Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmNCT00477971Mayo Clinic89
终止
1 期
Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer PatientsAdenocarcinoma of the ProstateRecurrent Prostate CancerStage I Prostate CancerStage III Prostate CancerStage IV Prostate CancerProstate CancerNCT00879619John P. Fruehauf4
终止
2 期
Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate CancerProstate CancerNCT00348816The University of Texas Health Science Center at San Antonio21
Unknown
3 期
Combination Chemotherapy Plus Steroid Therapy in Treating Children With Acute Lymphoblastic Leukemia or Lymphoblastic Non-Hodgkin's LymphomaLymphomaLeukemiaNCT00003728European Organisation for Research and Treatment of Cancer - EORTC1,500