A Phase I/II study evaluating the safety and activity of Pegylated recombinant human Arginase (BCT-100) in Relapsed/refractory cancers of Children and young adults

niversity of Birmingham0 个研究点目标入组 49 人开始时间: 2018年3月27日最近更新: 2024年2月27日

适应症

试验速览

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38357205/ (added 15/02/2024)

•1. Aged 1- <25 years old at the time of study registration
•2. Histologically confirmed disease in one of the following four groups:
•2.1. Group 1 - Acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML)
•2.2. Group 2 - Neuroblastoma
•2.3. Group 3 - Sarcoma
•2.4. Group 4 - High grade glioma (as defined by 2016 WHO CNS classification)
•3. Radiological or laboratory evidence of disease progression (during or after completion of first line treatment) or any subsequent recurrence (biopsy at relapse is not mandated)
•4. Measurable bone marrow disease (group 1) or at least one evaluable radiological site of disease (group 2, 3 and 4)
•5. Adequate liver function defined as a total bilirubin =1.5x the upper limit of normal for age and ALT = 3x the upper limit of normal for age
•6. Documented negative pregnancy test for female patients of childbearing potential within 7 days of trial entry
•7. Sexually active patients must agree to use adequate and appropriate contraception while on study drug and for 12 months following treatment discontinuation
•8. Written informed consent given by patient and/or parents/legal representative

•1. Previous treatment with another therapeutic arginine-depleting drug (bacterial or human) or arginase inhibitor
•2. Presence of any >= CTCAE grade 3 clinically significant treatment-related toxicity from prior therapies
•3. Pregnant or lactating female
•4. Evidence of uncontrolled infection

发起方