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

niversitaetsklinikum Tuebingen AöR0 个研究点目标入组 20 人开始时间: 2024年7月2日最近更新: 2024年8月21日

试验速览

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•Age >=3 to <18 years, B-lineage (CD19 positive) ALL (B, pro-B, pre-B or c-ALL), Refractory to standard treatment or with relapsed disease, Patients must have either underwent a first allogeneic stem cell transplantation with newly emerging or persistent MRD MRD =10E-4) irrespective of MRD after SCT or underwent a second or subsequent allogeneic stem cell transplantation irrespective of MRD after SCT load posttransplant or have received stem cell transplantation without having reached a sufficient molecular remission prior to transplant (defined as, Informed consent must be given by patients or legal representatives

•Frank relapse (>5% leukemic blasts), 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., 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

发起方

niversitaetsklinikum Tuebingen AöR