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Completed
NCT03568461
Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
Conditions: Follicular Lymphoma
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 98
Sponsor: Novartis Pharmaceuticals
Location: City of Hope National Medical Center Duarte California
Summary
This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.
Eligibility Criteria
Inclusion Criteria:
* Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)
* Radiographically measurable disease at screening
Exclusion Criteria:
* Evidence of histologic transformation
* Follicular Lymphoma Grade 3B
* Prior anti-CD19 therapy
* Prior gene therapy
* Prior adoptive T cell therapy
* Prior allogeneic hematopoietic stem cell transplant
* Active CNS involvement by malignancy
Other protocol-defined Inclusion/Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT03568461). StuddyBuddy aggregates publicly available trial information.