NCT00317408Unknown不适用
Treatment Protocol for Relapsed Anaplastic Large Cell Lymphoma of Childhood and Adolescence
European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma192 个研究点 分布在 5 个国家目标入组 96 人开始时间: 2004年4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
- 96
- 试验地点
- 192
- 主要终点
- Event-free survival as measured by the Kaplan-Meier method
研究概览
简要总结
RATIONALE: Giving combination chemotherapy and total-body irradiation before a peripheral stem cell transplant that uses the patient's or a donor's stem cells, helps stop both the growth of cancer cells and the patient's immune system from rejecting the stem cells. When the stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy and total-body irradiation followed by a stem cell transplant may be an effective treatment for anaplastic large cell lymphoma.
PURPOSE: This clinical trial is studying how well combination chemotherapy followed by stem cell transplant works in treating young patients with progressive or relapsed anaplastic large cell lymphoma.
详细描述
OBJECTIVES:
Primary
- Improve the probability of event-free survival in children and adolescents with early progression of anaplastic large cell lymphoma (ALCL) and/or relapse of ALCL with CD3-positive immunophenotype treated with reinduction combination chemotherapy followed by allogeneic or autologous stem cell transplantation.
- Determine whether a conditioning regimen comprising carmustine, etoposide phosphate, cytarabine, and melphalan (BEAM) (without total body irradiation) for autologous stem cell transplantation is an effective treatment for patients with relapsed CD3-negative ALCL occurring after the intensive phase of treatment.
- Determine the impact of vinblastine in patients with late relapse of CD3-negative ALCL who have not received vinblastine during frontline therapy.
Secondary
- Determine overall survival and treatment-related mortality in patients treated with these regimens.
- Determine acute and long-term toxicity in patients treated with these regimens.
- Determine the rate of acute and chronic graft-vs-host disease in patients treated with allogeneic stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 anaplastic large cell lymphoma (ALCL)
- •Progressive disease OR first relapse
- •No second or subsequent relapse of ALCL
- •Slides available for national central pathology review
- •Availability of 1 of the following (for allogeneic stem cell transplantation only):
- •HLA-identical matched sibling donor
- •10/10 HLA-matched nonsibling donor (related or unrelated)
- •9/10 HLA-matched nonsibling donor (1-antigen-mismatched related or unrelated donor)
- •< 9/10 HLA-mismatched donor (related or unrelated)
- •Stem cells may be obtained from unmanipulated bone marrow or peripheral blood stem cells after filgrastim (G-CSF) stimulation
- •PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Adequate hepatic, renal, and cardiac function
- •No HIV infection or AIDS
- •No severe immunodeficiency
- •No other prior malignancy
- •No pre-existing disease or condition prohibiting study treatment
- •PRIOR CONCURRENT THERAPY:
- •At least 2 months since prior chemotherapy or radiotherapy
- •No significant pretreatment for first relapse
- •No prior organ transplantation
- •No concurrent participation in another clinical trial
排除标准
- 未提供
结局指标
主要结局
Event-free survival as measured by the Kaplan-Meier method
次要结局
- Acute and long term toxicity
- Proportion of patients who are treated on protocol among all patients who meet the inclusion criteria
- Overall survival
- Rate of acute and chronic graft-vs-host disease in patients with allogeneic stem cell transplantation
- Treatment related mortality
研究者
研究点 (192)
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