Comparison of alternate-week versus continuous steroid therapy during induction in acute lymphoblastic leukemia: A study on efficacy and toxicity outcome
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- To compare the rate of complete
研究概览
简要总结
This is a prospective, interventional study designed to compare alternate week versus continuous steroid therapy during induction in patients with acute lymphoblastic leukemia. Steroids are an essential component of induction chemotherapy but are associated with significant toxicity. The study aims to determine whether alternate week steroid administration provides similar efficacy with reduced toxicity compared to continuous steroid therapy. Patients will be randomized into two groups, one receiving continuous steroids and the other receiving alternate week steroids during induction. Outcomes assessed will include remission status, minimal residual disease, treatment related toxicities, and supportive care requirements. The results are expected to provide evidence for optimizing steroid scheduling to improve both safety and efficacy in the management of acute lymphoblastic leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly diagnosed B-ALL and T-ALL ECOG 0-2 and fit to start therapy.
排除标准
- 未提供
结局指标
主要结局
To compare the rate of complete
时间窗: To compare the rate of complete | remission (CR), including measurable | residual disease (MRD) negativity, at the end of induction (Day 29- 35) between patients receiving intermittent versus | continuous steroid therapy. | To assess the rate of early | mortality (induction deaths) in each | treatment group. | Patients will be assessed at the end of induction (4 weeks).
remission (CR), including measurable
时间窗: To compare the rate of complete | remission (CR), including measurable | residual disease (MRD) negativity, at the end of induction (Day 29- 35) between patients receiving intermittent versus | continuous steroid therapy. | To assess the rate of early | mortality (induction deaths) in each | treatment group. | Patients will be assessed at the end of induction (4 weeks).
residual disease (MRD) negativity, at the end of induction (Day 29- 35) between patients receiving intermittent versus
时间窗: To compare the rate of complete | remission (CR), including measurable | residual disease (MRD) negativity, at the end of induction (Day 29- 35) between patients receiving intermittent versus | continuous steroid therapy. | To assess the rate of early | mortality (induction deaths) in each | treatment group. | Patients will be assessed at the end of induction (4 weeks).
continuous steroid therapy.
时间窗: To compare the rate of complete | remission (CR), including measurable | residual disease (MRD) negativity, at the end of induction (Day 29- 35) between patients receiving intermittent versus | continuous steroid therapy. | To assess the rate of early | mortality (induction deaths) in each | treatment group. | Patients will be assessed at the end of induction (4 weeks).
To assess the rate of early
时间窗: To compare the rate of complete | remission (CR), including measurable | residual disease (MRD) negativity, at the end of induction (Day 29- 35) between patients receiving intermittent versus | continuous steroid therapy. | To assess the rate of early | mortality (induction deaths) in each | treatment group. | Patients will be assessed at the end of induction (4 weeks).
mortality (induction deaths) in each
时间窗: To compare the rate of complete | remission (CR), including measurable | residual disease (MRD) negativity, at the end of induction (Day 29- 35) between patients receiving intermittent versus | continuous steroid therapy. | To assess the rate of early | mortality (induction deaths) in each | treatment group. | Patients will be assessed at the end of induction (4 weeks).
treatment group.
时间窗: To compare the rate of complete | remission (CR), including measurable | residual disease (MRD) negativity, at the end of induction (Day 29- 35) between patients receiving intermittent versus | continuous steroid therapy. | To assess the rate of early | mortality (induction deaths) in each | treatment group. | Patients will be assessed at the end of induction (4 weeks).
次要结局
- To compare the incidence of(induction-related infections (bacterial,)
- To assess and compare the(frequency of steroid-related complications in both groups.)
- To evaluate leukemia-free(survival and overall survival at 6 months)
研究者
Abirami
All India institute of medical sciences, New Delhi