Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 960
- 试验地点
- 311
- 主要终点
- Proportion of patients with identification of a priori specified genomic and immunophenotypic targets who enroll on a sub-trial
研究概览
简要总结
This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.
详细描述
PRIMARY OBJECTIVES:
I. To utilize clinical and biological characteristics of acute leukemias to screen for patient eligibility for available phase I/II Pediatric Acute Leukemia (PedAL) sub-trials.
II. To maintain a longitudinal and comprehensive registry, as well as a specimen bank, from relapse in children and young adults with acute leukemias.
OUTLINE:
Patients undergo collection of blood and/or bone marrow samples at baseline, end of treatment cycle(s), and at relapse/refractory disease status (if applicable).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be less than 22 years of age at the time of study enrollment
- •Patient must have one of the following at the time of study enrollment:
- •Patient has known or suspected relapsed/refractory (including primary refractory) AML as defined in protocol
- •This includes isolated myeloid sarcoma
- •Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS)
- •Patient has known or suspected relapsed ALL as defined in protocol that meets one of the following criteria:
- •Second or greater B-ALL medullary relapse, excluding KMT2Ar
- •Any first or greater B-ALL medullary relapse involving KMT2Ar
- •Any first or greater T-ALL medullary relapse with or without KMT2Ar
- •Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia (MPAL) as defined in protocol
- •Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment-related AML (t-AML)
- •Patient has known or suspected de novo or relapsed/refractory (including primary refractory) myelodysplastic syndrome (MDS) or treatment-related myelodysplastic syndrome (t-MDS)
- •Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse.
- •Patient has known or suspected de novo or relapsed/refractory (including primary refractory) juvenile myelomonocytic leukemia (JMML)
- •Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse.
- •All patients and/or their parents or legal guardians must sign a written informed consent
- •All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
排除标准
- 未提供
研究组 & 干预措施
Screening (biospecimen collection)
Patients undergo collection of blood and/or bone marrow samples at baseline, end of treatment cycle(s), and at relapse/refractory disease status (if applicable).
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
Proportion of patients with identification of a priori specified genomic and immunophenotypic targets who enroll on a sub-trial
时间窗: Up to 5 years
The proportion will be calculated as the percent of eligible patients who are identified to have an a priori specified genomic or immunophenotypic target and who enroll on at least one of the sub-trials. The corresponding confidence interval will be constructed.
Maintain a longitudinal and comprehensive registry, as well as specimen bank of children and young adults with acute leukemias
时间窗: Up to 5 years
The number of patients with at least one specimen submitted to the bank will be reported.
次要结局
未报告次要终点