Study of Out of Specification for Tisagenlecleucel

  • STATUS
    Recruiting
  • End date
    May 19, 2022
  • participants needed
    42
  • sponsor
    Novartis Pharmaceuticals
Updated on 24 September 2021
Investigator
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (7.5 mi away) Contact
+27 other location
lymphoma
leukemia
leukapheresis
follicular lymphoma
b-cell lymphoma

Summary

This study will evaluate the safety of tisagenlecleucel that is out of specification( OOS) for release as commercial product.

Specifically, this study will evaluate the safety of tisagenlecleucel in pediatric/young adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (pALL) and adult patients with r/r large B-cell lymphoma (LBCL) including diffuse large B-cell lymphoma (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 product information for tisagenlecleucel in the respective country/region. In addition to safety, key efficacy of tisagenlecleucel that is out of specification (OOS) for commercial release will also be evaluated.

Description

Patients whose final manufactured tisagenlecleucel batches do not meet the approved local commercial release specifications are eligible for inclusion.Each case will be individually assessed for the expected benefit risk profile prior to release to the patient. Following the infusion of OOS tisagenlecleucel, the patient will be followed for 3 months on this study.

Details
Condition Diffuse Large B-Cell Lymphoma, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, diffuse large cell lymphoma, diffuse large b cell lymphoma, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia
Treatment Tisagenlecleucel
Clinical Study IdentifierNCT04094311
SponsorNovartis Pharmaceuticals
Last Modified on24 September 2021

Eligibility

Yes No Not Sure

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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