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

  • Interventional
  • Active
  • NCT03568461
Eligibility Details Visit Clinicaltrials.gov

A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel (CTL019) 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.

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT03568461

IRB#IRB18-1230

Lead SponsorNovartis Pharmaceuticals

Lead PhysicianPeter Riedell

Collaborator(s)N/A

EligibilityAll
18 Years and up
Active