Evaluating safety of tisagenlecleucel that doesn't meet specifications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase IIIb study aims to assess the safety and efficacy of tisagenlecleucel (CTL019) in pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia and adult patients with relapsed/refractory diffuse large B-cell lymphoma. The study is single-arm and open-label, focusing on patients whose manufactured tisagenlecleucel product does not meet commercial release specifications. Participants will receive a single infusion of CTL019 and will be monitored for safety and efficacy over specified follow-up periods. The study is conducted across multiple Novartis investigative sites in Ontario, Canada.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novartis Investigative Site
  Nagoya, Aichi-ken, Japan Recruiting
• Novartis Investigative Site
  Nagoya, Aichi-ken, Japan Recruiting
• Novartis Investigative Site
  Tōon, Ehime, Japan Recruiting
• Novartis Investigative Site
  Gifu, Gifu, Japan Recruiting
• Novartis Investigative Site
  Sapporo, Hokkaido, Japan Recruiting
• Novartis Investigative Site
  Sapporo, Hokkaido, Japan Recruiting

+5 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: Novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.