Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma

This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.

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.

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03568461.

University of Chicago Comprehensive Cancer Center

Status: Temporarily closed to accrual

Name Not Available

This single-arm, open label study had the following sequential phases: Screening,

Pretreatment, Treatment and Follow-up. In the Pre-treatment phase, the patient could

undergo bridging therapy (optional) and lymphodepleting (LD) chemotherapy. Treatment and

Follow-up Phase included tisagenlecleucel infusion, and safety and efficacy follow-up for

at least 24 months. For all the patients who received tisagenlecleucel infusion,

additional survival follow-up was to be performed to determine survival status every 3

months.

Trial PhasePhase II

Trial Typetreatment

Lead OrganizationNovartis Pharmaceuticals Corporation

Description