A Phase IIIb Study of the Safety and Efficacy of Tisagenlecleucel Out of Specification for Commercial Release in Patients Who Are Consistent With the Label Indication

ovartis Pharma. K.K.0 个研究点目标入组 200 人开始时间: 2019年10月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Patients eligible for inclusion in this study must meet all of the following criteria:
•1. Signed informed consent/assent must be obtained for this study prior to
•participation in the study.
•2. Patients for whom the final manufactured tisagenlecleucel product does not meet
•the commercial release specifications.
•3. Not excluded from commercial manufacturing under the Health Authority-approved
•tisagenlecleucel prescribing information for their respective country/region.
•4. OOS material has not been deemed to pose an undue safety risk to the patient.
•5. Patient is suffering from a serious or life-threatening disease or condition.
•6. Repeat leukapheresis is not clinically appropriate per the investigator assessment.

•For Part 1, Patients meeting any of the following criteria are not eligible for inclusion in this study.
•1. Human immunodeficience virus (HIV) positive patients.
•2. Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus
•3. Patients with primary central nervous system (CNS) lymphoma.
•4. History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel.
•5. Uncontrolled active infection or inflammation.
•6. Any medical condition identified by the investigator that may impact the assessment of the safety or efficacy outcomes in relation to study treatment.
•7. Pregnant or nursing (lactating) women.
•For Part 2, exclusion criteria are not set; however, administration should be performed in accordance with the latest versions of the package insert of Kymriah.

发起方

ovartis Pharma. K.K.