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临床试验/CTRI/2024/11/076407
CTRI/2024/11/076407招募中不适用

Immunotherapy in Children and Adolescents with Hodgkin Lymphoma Real World Data

CanKids KidsCan6 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月20日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
6
主要终点
response of various immunotherapeutic agents in children and adolescents with HL in India

研究概览

简要总结

The outcomes of Hodgkin lymphoma in children and adolescents who receive optimal treatment approach in excess of 90% in patients with early stage disease and 80% in patients with advanced stage disease. Nevertheless, 10-20% patients either have refractory disease or have a recurrence.  A significant proportion of them can be effectively salvaged with further chemotherapy/ immunotherapy including high dose chemotherapy with stem cell rescue.

The management of Hodgkin Lymphoma is currently undergoing a major paradigm shift with increasing role of immunotherapy especially for patients with relapsed/ refractory disease but also in frontline setting primarily with the specific purpose of improving outcomes with limited toxicity both in the short and long-term.  The precise place of immunotherapy (anti CD30 monoclonal antibody and PDL1 blockade) in children is being defined in prospective collaborative studies by various consortia.

These novel agents, however, come at a considerable cost and our it is unclear whether there will be novel toxicities that may emerge with increasing cumulative experience. In low-middle-income countries, these modalities are largely reserved for relapsed/refractory disease frequently in off-label settings. For e.g., nivolumomab is currently licensed for post ASCT relapse but economic considerations mean that it may be used in pre-transplant settings as well to achieve response and allow for ASCT to be done. Experience at individual centers is limited. It is therefore, vital that we understand and collate real world data especially the  response rates documented in various clinical settings and the adverse events observed as we work towards identifying optimal strategies in our settings for all patients.

This simple retrospective study aims to capture the above.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Year(s) 至 21.00 Year(s)(—)
性别
All

入选标准

  • Children aged between 0-21 years who has received agents Brentuximab, Nivolumomab, Pembroluzimab from January 2018- December 2023
  • Full Records and follow-up should be available.

排除标准

  • Full records unavailable.
  • Follow-up details unavailable.

结局指标

主要结局

response of various immunotherapeutic agents in children and adolescents with HL in India

时间窗: 2 Years

次要结局

  • To document the challenges in terms of response evaluation to these agents(1 Years)

研究者

发起方
CanKids KidsCan
申办方类型
Other [Social Sector (NGO)]
责任方
Principal Investigator
主要研究者

Dr Amita Mahajan

Indraprastha Apollo Hospitals

研究点 (6)

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