跳至主要内容
临床试验/CTRI/2025/01/079435
CTRI/2025/01/079435尚未招募不适用

Correlation of adverse prognostic factors with survival outcomes in paediatric Precursor-B Lymphoblastic Leukemias: a single centre experience

NA1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2025年2月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
NA
入组人数
800
试验地点
1
主要终点
To study the prognostic factors in B-LBLs on the basis of age TLC baseline immunophenotype ploidy status genetic features and CNS disease and classify them into standard and high risk subtypes AND

研究概览

简要总结

Successful treatment of paediatric Precursor-B Lymphoblastic Leukemias (B-LBL) relies on assigning patients to appropriate risk groups. Modern protocols use a combination of age, white cell count (WCC), CNS involvement, immunophenotype, genetics and treatment response to assign patients to different treatment pathways which determines chemo-intensity, randomisations offered and eligibility for transplant or CAR-T. The primary aim of this retrospective observational study is to study the prognostic factors in B-LBLs on the basis of age, TLC, baseline immunophenotype, ploidy status, genetic features and CNS disease and classify them into standard and high risk subtypes and to study their correlation with EOI MRD status and survival outcomes (3 year-RFS and OS). This study will involve approximately 800 newly diagnosed adult (<15 years) patients of B-LBL. This will help in understanding the prognostic impact of the immunophenotypic patterns and the genetic profile of our BLBL patients, and may guide in deciding the targeted chemotherapy in selected cases.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Newly diagnosed patients of pediatric BLBL enrolled between July 2020 to June2023.

排除标准

  • Patients with relapsed disease or partially-treated from outside Those who refuse to give consent for the study.
  • Those who were lost to follow-up without completing chemotherapy.

结局指标

主要结局

To study the prognostic factors in B-LBLs on the basis of age TLC baseline immunophenotype ploidy status genetic features and CNS disease and classify them into standard and high risk subtypes AND

时间窗: MRD Day 28 and 72 of chemotherapy RFS 1 year RFS 3 year OS at last follow up

To study their correlation with EOI MRD status and survival outcomes 3 year RFS and OS

时间窗: MRD Day 28 and 72 of chemotherapy RFS 1 year RFS 3 year OS at last follow up

次要结局

未报告次要终点

研究者

发起方
NA
申办方类型
Other [na]
责任方
Principal Investigator
主要研究者

DR NEHA SINGH

TATA MEMORIAL CENTRE

研究点 (1)

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