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Clinical Trial 19720

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#:

Phase: Phase II
Prinicipal Investigator:

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Overview

Study Title

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

Summary

This study is to determine the efficacy and safety of tisagenlecleucel in adult patients with refractory or relapsed follicular lymphoma

Objective

Evaluate the efficacy of tisagenlecleucel therapy as measured by complete response rate determined by Independent Review Committee in the full analysis set based on Lugano 2014 classification response criteria

Treatments

Therapies

Medications

Tisagenlecleucel ()

Inclusion Criteria

  • Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)
  • Radiographically measurable disease at screening
  • Other criteria may apply

  • 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 criteria may apply

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