Study of Out of Specification for Tisagenlecleucel (NCT04094311) | Clinical Trial Compass
RecruitingPhase 3
Study of Out of Specification for Tisagenlecleucel
Canada, Japan200 participantsStarted 2019-11-21
Plain-language 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 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.
Who can participate
Age range
0 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 CTL0…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants with Adverse Events (AEs)
Timeframe: From Screening up to 3 months for Part 1 and 1 day for Part 2