Study of Out of Specification for Tisagenlecleucel
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 200
Summary
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Diffuse Large B Cell Lymphoma
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Phase IIIB StudyMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
Patients whose final manufactured tisagenlecleucel batches do not meet the approved local commercial release specifications are eligible for inclusion.Each case will be individually assessed for the expected benefit risk profile prior to release to the patient. Following the infusion of OOS tisagenl...
Patients whose final manufactured tisagenlecleucel batches do not meet the approved local commercial release specifications are eligible for inclusion.Each case will be individually assessed for the expected benefit risk profile prior to release to the patient. Following the infusion of OOS tisagenlecleucel, the patient will be followed for 3 months on this study.
Tracking Information
- NCT #
- NCT04094311
- Collaborators
- Not Provided
- Investigators
- Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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