Status:
RECRUITING
Study of Out of Specification for Tisagenlecleucel
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
B-cell Acute Lymphoblastic Leukemia
Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
Up to 100 years
Phase:
PHASE3
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 patient...
Detailed Description
This is a single-arm, open-label, multicenter, interventional Phase IIIb study in pediatric/young adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (pALL) and adult pat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04094311
Start Date
November 21 2019
End Date
March 31 2026
Last Update
May 6 2025
Active Locations (53)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Hamilton, Ontario, Canada, L8V 5C2
2
Novartis Investigative Site
Ottawa, Ontario, Canada, K1H 8L6
3
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 1X8
4
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9