A phase II trial to assess the activity of Gemtuzumab Ozogamicin Therapy in Haemophagocytic lymphohistiocytosis (HLH) or Macrophage activation syndrome (MAS) or relapsed/refractory solid tumours - GOTHAM

niversity of Birmingham0 个研究点目标入组 20 人开始时间: 2020年9月18日最近更新: 2020年11月23日

适应症

试验速览

暂无简介。

•Aged >1 year old at the time of trial entry
•Diagnosis of HLH or MAS disease primary, secondary or refractory to treatment at time of enrolment
•Histologically confirmed diagnosis of solid cancer with radiological or clinical evidence of disease progression (during or after completion of at least one previous treatment) or any subsequent recurrence (biopsy at relapse is not mandated)
•Must have adequate liver function (solid cancer patients only):
•o Total bilirubin = x2 upper limit of normal (ULN)
•o Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) = 2.5 x ULN
•Documented negative pregnancy test for female patients of childbearing potential within 7 days prior to trial entry
•Sexually active patients must agree to use 2 methods of adequate and appropriate contraception while on trial drug and for 4 months (male) and 7 months (female) following treatment discontinuation
•Written informed consent given by patient and/or parents/legal guardian
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 10
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 9
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•Evidence of sinusoidal obstruction syndrome (SOS) / veno-occlusive disease (VOD)
•Previous treatment with another CD33 targeting antibody or immunotoxin
•Hypersensitivity to Gemtuzumab Ozogamicin or to any of the excipients
•Pregnant or lactating female

发起方