Study of Out of Specification for Tisagenlecleucel
- 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.
- Registration Number
- JPRN-jRCT1080224903
- Lead Sponsor
- ovartis Pharma. K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- 200
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
(HCV).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety<br>Evaluate the safety of final manufactured tisagenlecleucel product that is OOS for commercial release in patients with r/r pALL (Group A) and r/r LBCL (Group B) for Part 1, and r/r pALL (Group A) and r/r NHL (Group C) for Part 2.
- Secondary Outcome Measures
Name Time Method Efficacy<br>Evaluate the efficacy of final manufactured tisagenlecleucel product that is OOS for commercial release in patients with r/r pALL (Group A) and r/r LBCL (Group B), as measured by the best overall response/remission rate within 3 months post infusion (Efficacy evaluation is performed only for Part 1).