Randomized controlled study to evaluate efficacy of dexamethasone versus prednisolone in induction phase in pediatric and adolescent acute lymphoblastic leukemia with respect to day 33 bone marrow minimal residual disease response

All India Institute of Medical Sciences Rishikesh1 个研究点分布在 1 个国家目标入组 160 人开始时间: 2022年10月1日最近更新: 2023年8月4日

试验速览

阶段: 不适用
状态: 已完成
发起方: All India Institute of Medical Sciences Rishikesh
入组人数: 160
试验地点: 1
主要终点: To compare bone marrow minimal residual disease (MRD) response by flowcytometry on day 33 of induction phase chemotherapy in the dexamethasone and prednisolone treatment groups

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The proposed study will compare the efficacy ofdexamethasone versus prednisolone on treatment outcomes with respect to Day 33 MinimalResidual Disease during induction phase chemotherapy in pediatric ALL at AIIMSRishikesh, in view of no published data on this theme in Indian pediatric ALLpatients

研究设计

研究类型: Interventional
分配方式: Permuted block randomization, fixed
盲法: Not Applicable

入排标准

年龄范围: 1.00 Year(s) 至 24.00 Year(s)（—）
性别: All

入选标准

•Newly diagnosed patients of acute lymphoblastic leukemia (both B-ALL & T-ALL), between 1 year to 24 years of age, of any gender, where informed consent of parent/guardian is available.

排除标准

•1.Infantile acute lymphoblastic leukemia (age < 1 year).
•2.Patients of lymphoblastic lymphoma (LBL).
•3.Relapsed cases of acute lymphoblastic leukemia.
•4.Patients who have received dexamethasone, prednisolone or any other chemotherapy within 4 weeks of enrollment in study.

结局指标

主要结局

To compare bone marrow minimal residual disease (MRD) response by flowcytometry on day 33 of induction phase chemotherapy in the dexamethasone and prednisolone treatment groups

时间窗: 0 days and 33 days

次要结局

To compare Day 33 bone marrow morphological response in the two treatment groups.(2. To compare Day 15 bone marrow morphological response & MRD status in the two treatment groups as per protocol.)

研究者

发起方

All India Institute of Medical Sciences Rishikesh

申办方类型

Government medical college

研究点 (1)

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