Study of Out of Specification for Tisagenlecleucel
B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma
About this trial
This is an interventional treatment trial for B-cell Acute Lymphoblastic Leukemia focused on measuring out of specification, tisagenlecleucel, acute lymphoblastic leukemia, large B-cell lymphoma, relapsed/refractory, pediatric, young adult patients
Eligibility Criteria
Key inclusion criteria:
- Signed informed consent/assent must be obtained for this study prior to participation in the study.
- Patients for whom the final manufactured tisagenlecleucel product does not meet the commercial release specifications.
- Not excluded from commercial manufacturing under the Health Authority-approved tisagenlecleucel prescribing information for their respective country/region.
- OOS material has not been deemed to pose an undue safety risk to the patient.
- Patient is suffering from a serious or life-threatening disease or condition.
- Repeat leukapheresis is not clinically appropriate per the investigator assessment.
Key exclusion criteria:
For part 1, patients meeting any of the following criteria are not eligible for inclusion in this study:
- Human immunodeficience virus (HIV) positive patients.
- Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
- Patients with primary central nervous system (CNS) lymphoma.
- History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel.
- Uncontrolled active infection or inflammation.
- Any medical condition identified by the investigator that may impact the assessment of the safety or efficacy outcomes in relation to study treatment.
- 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 CTL019.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group A: pALL
Group B: r/r LBCL
Group C: r/r NHL
Pediatric/young adult patients with r/r pALL who meet the indication in the Health Authority-approved CTL019 package insert in the respective country/region whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient.
Adult patients with r/r LBCL including DLBCL not otherwise specified, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, that is consistent with the Health Authority-approved indication in the package insert for CTL019 in the respective country/region whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient.
Adult patients with r/r NHL in consistent with the Health Authority approved indication in the package insert for CTL019 in Japan whose final manufactured product is OOS for commercial release, but it is considered that the benefit-risk profile may remain favorable and the usual expected benefits of infusing such a product outweigh the potential risks for the patient.