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Taking peoplePhase 3

Tests tisagenlecleucel in patients with leukemia or lymphoma

Tests tisagenlecleucel, a cell therapy, in patients with B-cell leukemia or lymphoma.

Plain-language title generated from the registry record
Registry title: Study of Out of Specification for Tisagenlecleucel

Key facts

Where
Hamilton, Montreal, Ottawa, Québec, and Toronto, CanadaSee the 5 sites
Phase
Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for patients with B-cell acute lymphoblastic leukemia or diffuse large B-cell lymphoma whose tisagenlecleucel (CTL019) cell product did not meet the commercial release specifications.

Age
0 to 100 years
Sex
All sexes can join.
Disease stage
A serious or life-threatening disease within the approved label for tisagenlecleucel.
Earlier treatment
The final tisagenlecleucel product made for the patient did not meet commercial release specifications. Repeating leukapheresis (collecting white blood cells again) is not clinically appropriate per the investigator.

Main reasons for not taking part

  • HIV-positive (Part 1)
  • Active hepatitis B or hepatitis C virus replication (Part 1)
  • Primary central nervous system lymphoma (Part 1)
  • Uncontrolled active infection or inflammation (Part 1)
  • Pregnant or nursing women (Part 1)

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 0 and 100 years old?

Source: NCT04094311, who can take part

Where in Canada

  • Hamilton, OntarioHospital not named in the registryContact: Novartis PharmaceuticalsNo longer taking part
  • Montreal, QuebecHospital not named in the registryContact: Novartis PharmaceuticalsNo longer taking part
  • Ottawa, OntarioHospital not named in the registryContact: Novartis PharmaceuticalsNo longer taking part
  • Québec, QuebecHospital not named in the registryContact: Novartis PharmaceuticalsNo longer taking part
  • Toronto, OntarioHospital not named in the registryContact: Novartis PharmaceuticalsNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Novartis Pharmaceuticals
Trial code
NCT04094311
Record updated
15 September 2026
Original description
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 CTL019 in the patients treated within the approved label by Japan Health Authority in Part 2. Only for Part 1, in addition to safety, key efficacy of CTL019 will also be evaluated.Read full original descriptionShow less

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

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 CTL019 in the patients treated within the approved label by Japan Health Authority in Part 2. Only for Part 1, in addition to safety, key efficacy of CTL019 will also be evaluated.

Inclusion: 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: Human immunodeficience virus (HIV) positive patients; Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus (HCV); 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; For part 1, patients meeting any of the following criteria are not eligible for inclusion in this study:; Patients with primary central nervous system (CNS) lymphoma; 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.

ClinicalTrials.gov NCT04094311