2024-518316-39-00招募中3 期
Ruxolitinib for childhood ALL in Poland (Rux-cALL-Pol 2020 trial) - Single-arm interventional study with ruxolitinib and AIEOP-BFM 2017 Poland or AIEOP-BFM 2017 standard of care chemotherapy in children with acute lymphoblastic leukemia and confirmed activation of JAK/STAT pathway.
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 15
- 主要终点
- Proportion of patients with MRD(-) at TP2.
研究概览
简要总结
Compare the rate of MRD(-) at TP2 in ruxolitinib + Consol. IB ext. to appropriate external control.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed ALL treated according to AIEOP-BFM 2017 Poland or AIEOP-BFM 2017 standard of care protocol.
- •Confirmed genetic lesion causing activation of JAK-STAT pathway (CRLF2, JAK2, EPOR, or CRLF2 expression on leukemic cells`surface).
- •Stratification as early high risk: - no complete remission on day 33 OR - positivity for KMT2A-AFF1 OR - positivity for TCF3-HLF OR o hypodiploidy <45 chromosomes OR - FCM-MRD in bone marrow on day 15 ≥ 10% and not ETV6-RUNX1 positive OR - IKZF1plus and PCR-MRD at TP1 positive or inconclusive and not positive for ETV6-RUNX1, TCF3-PBX1 or KMT2A rearr. other than KMT2A-AFF1 OR - PCR-MRD at TP1 ≥ 5x10-4 OR -age < 1 year and any KMT2A rearrangement
排除标准
- •ALL classified as a standard or intermediate risk (SR, MR).
- •Early high risk (eHR) ALL without genetic lesions within CRLF2, JAK2, EPOR, or CRLF2 expression on leukemic cells.
- •Participation in another clinical trial except for ad-on trials within the scope of supportive care approved by the sponsor
- •Other condition (either pre-existing or related to leukemia biology as present at diagnosis) or circumstances that significantly conflict with the treatment according to the protocol
结局指标
主要结局
Proportion of patients with MRD(-) at TP2.
Proportion of patients with MRD(-) at TP2.
次要结局
- Frequency and grading of adverse events in Consol. IB ext. phase (number, percentage, number per patient-days, number per each grade of significance).
- Incidence of treatment-related adverse and severe adverse events.
研究者
Wojciech Młynarski
Scientific
Medical University Of Lodz
研究点 (15)
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