ICiCLe-ALL-24 – The Indian Collaborative Childhood Leukaemia Randomised Trial for Children and Adolescents with Acute Lymphoblastic Leukaemia 2024
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 2,567
- 试验地点
- 6
- 主要终点
- Event free survival between the R1 and R2 randomisation arms.
研究概览
简要总结
Rationale/ gaps in existing knowledge:
Acute lymphoblastic leukemia (ALL) is the most common childhood cancer, with an estimated 15,000 children diagnosed in India annually. While the outcome for ALL is ~90% in high-income nations, Indian outcomes are suboptimal. The ICiCle ALL-14 (Indian Childhood CollaborativeLeukemia group) trial, carried out between 2016-2022, standardized the treatment of ALL in India and improved the outcomes of childhood ALL. While much improved as compared to historical Indian data, outcomes are lower than international data. Additionally, relapse rates from the trial are higher than the expected. The ICICLE ALL-24 trial will further optimize the treatment of childhood ALL with the end goal of improving the OS and EFS and decreasing the relapse rate. To this end, improvement in risk stratification of ALL will be done, and treatment strategy will be further refined among the various sub-groups of ALL.
Novelty: -
In the trial, newer genetic risk stratification strategies will be used to refine the pre-existing risk stratification in ALL including cytogenetic markers: IKZF1del, Philadelphia-like; TCF3::HLF1; Hypodiploidy; iAMP21, and MEF2D. More sensitive assessments for MRD will be developed and used during this study. Novel treatment modifications and adaptations will be assessed in this trial, including, 1. non-randomized modification of high-dose methotrexate (HDMTX) into 2 blocks of 2-cycles each, as compared to serial administration of 4-cycles over 8-weeks, 2. randomized comparison between high-dose methotrexate (HDMTX) versus Capizzi methotrexate (CMTX) in non-standard risk (SR)-ALL, and 3. Randomization between dexamethasone and prednisolone during induction. The end-goal is a reduction in relapse rate while reducing toxicity.
Objectives:
-
To improve the outcome of children with ALL in India with enhanced risk-stratification using novel genetic criteria and improved measurable residual disease assessment.
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To assess whether the use of dexamethasone instead of prednisolone in induction may lead to better EFS, and decreased intramedullary relapses without an increase in toxicity.
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To assess whether in the Indian context, CMTX may be a better option than HDMTX for ALL.
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To assess the efficacy of split-administration of HDMTX.
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
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly diagnosed pediatric acute lymphoblastic leukemia or lymphoblastic lymphoma.
排除标准
- •Age less than 1 year
- •Age more than 18 years
- •Mature B-ALL
- •Down Syndrome
- •Mixed Phenotype Acute Leukaemia.
结局指标
主要结局
Event free survival between the R1 and R2 randomisation arms.
时间窗: 3 years and 5 years from inclusion in study.
次要结局
- Event free survival in comparison to T-ALL cohort in ICiCLe-14 historical cohort.
- Overall survival, cummulative incidence of death, cummulative incidence of relapse and toxicity between the randomised arms and non randomised arms with historcial arms.(3 years and 5 years from inclusion in study.)
研究者
Venkatraman Radhakrishnan
Cancer Institute (W.I.A)