NCT04094311 Study of Out of Specification for Tisagenlecleucel
| NCT ID | NCT04094311 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | B-cell Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-11-21 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2019-11-21 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT04094311 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 100 Years, studying B-cell Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04094311 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT04094311 currently recruiting?
Yes, NCT04094311 is actively recruiting participants. Contact the research team at Novartis.email@novartis.com for enrollment information.
Where is the NCT04094311 trial being conducted?
This trial is being conducted at Hamilton, Canada, Ottawa, Canada, Toronto, Canada, Toronto, Canada and 11 additional locations.
Who is sponsoring the NCT04094311 clinical trial?
NCT04094311 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 200 participants.
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