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

  • Interventional
  • Recruiting
  • 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.

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

At a Glance

National Government IDNCT03568461

IRB#IRB18-1230

Lead SponsorNovartis Pharmaceuticals

Lead PhysicianPeter Riedell

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting