A Prospective Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab (MOR00208) in Pediatric Patients with Relapsed or Refractory Acute B Lineage Leukemia - Anti-CD19-A

niversity Hospital Tuebingen0 个研究点目标入组 39 人开始时间: 2022年6月30日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Age < 18 years at enrollment
•oonly children = 3 years at enrollment will be enrolled prior to the identification of the recommended Phase II dose (maximum tolerated dose, MTD)
•B-lineage (CD19 positive) ALL (B, pro-B, pre-B or c-ALL)
•Patients must have either underwent a first allogeneic stem cell transplantation with newly emerging or persistent MRD load posttransplant or have received stem cell transplantation without having reached a sufficient molecular remission prior to transplant (defined as MRD =10E-4) irrespective of MRD after SCT or underwent a second or subsequent allogeneic stem cell transplantation irrespective of MRD after SCT
•Informed consent must be given by patients or legal representatives
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 39
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Frank relapse (>5% leukemic blasts)
•Philadelphia chromosome-positive (Ph+) ALL
•Ejection fraction <25% on echocardiography
•Cystatin C-clearance <40ml/min
•Liver function abnormalities with bilirubin >4 mg/dL and elevation of transaminases higher than 400 U/L
•Severe infection (HIV, Chronic active viral hepatitis), tests have to be conducted at screening
•Acute GvHD III-IV or extensive chronic GvHD
•The following immunosuppressive drugs (= 1 week of administration): steroids = 1mg/kg body weight, cytostatics (except intrathecal/intracerebroventricular application for CNS treatment)
•Application of other experimental therapy modalities in the last 4 weeks
•Significant psychiatric disabilities, uncontrolled seizure disorders or severe peripheral neuropathy/ leukencephalopathy
•Signs of autoimmune disease (i.e. idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia)
•Subjects that do not agree to refrain from donating blood while on study drug
•Concurrent severe or uncontrolled medical disease which by assessment of the treating physician could compromise participation in the study
•Women during pregnancy and lactation
•History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.

发起方

niversity Hospital Tuebingen