JPRN-jRCT1080224903
Recruiting
Phase 3
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 sites200 target enrollmentOctober 1, 2019
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Pediatric/young adult patients with r/r pALL and adult patients with r/r LBCL (including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma) for Part 1, and r/r ALL and r/r NHL for Part 2.
- Sponsor
- ovartis Pharma. K.K.
- Enrollment
- 200
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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