This study is in progress, not accepting new patients

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

a study on Lymphoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Charalambos Andreadis

Description

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.

Official 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

Details

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.

Keywords

Follicular Lymphoma, Refractory or relapsed Follicular Lymphoma, Refractory, Relapsed, CTL019, Tisagenlecleucel, Chimeric antigen receptor, CAR19, CAR-T, Lymphoma

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • 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.

Locations

  • UCSF Medical Center .
    San Francisco California 94143 United States
  • City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr1
    Duarte California 91010 3000 United States

Lead Scientist at UCSF

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT03568461
Phase
Phase 2 Lymphoma Research Study
Study Type
Interventional
Participants
About 98 people participating
Last Updated