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临床试验/NCT01665001
NCT01665001Unknown2 期

Optimization of the Treatment of Adults With Precursor Lymphoid Neoplasms With Adjustment of the Type and Intensity of the Therapy for Age, Status of Minimal Residual Disease, Genetic and Phenotypic Features

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年8月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
200
试验地点
2
主要终点
Overall survival

研究概览

简要总结

The primary goal of this study by The Polish Adult Leukemia Group (PALG) is to verify if individual therapeutic approach taking into account biological and phenotypic differences as well as response at the level of minimal residual disease is associated with improved outcome of adults with precursor lymphoid neoplasms

详细描述

Between 1997-2010 the PALG run three prospective studies. In the most recent PLAG 5-2007 protocol attempts have been made to individualize treatment. In particular, stratification to high and standard risk group was based on both conventional clinical criteria and the level of MRD after induction and consolidation. Patients with unsatisfactory response were referred for allogeneic hematopoietic stem cell transplantation (alloHSCT). Interim analysis showed significant improvement compared to previous PALG 4-2002 protocol with regard to both overall survival and leukemia-free survival. The reasons of failure were relapses and non-relapse mortality (NRM) associated with alloHSCT.

In the current protocol we intend to further adjust the therapy for individual patients needs. We assume that this way we will be able to reduce the risk of relapse and NRM and improve the cure rate. All patients will receive multiagent induction and consolidation chemotherapy. The type and intensity of the therapy, as well as indications for allogeneic and autologous HSCT will depend on age, status of MRD, immunophenotype and the presence of BCR/ABL fusion gene.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • New diagnosis of PLN according to WHO 2008 classification
  • Age ≥18 years
  • Biological status allowing administration of induction therapy
  • Informed patient consent form signed

排除标准

  • Pregnancy
  • Psychiatric diseases
  • History of other malignancies
  • HIV infection
  • Active hepatitis
  • Hypersensitivity to drugs used in induction

结局指标

主要结局

Overall survival

时间窗: three years

次要结局

  • Leukemia-free survival(three years)

研究者

发起方
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice
申办方类型
Other
责任方
Sponsor

研究点 (2)

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