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

Novartis

Status and phase: Active, not recruiting; Phase 2

Conditions: Follicular Lymphoma

Treatments: Biological: tisagenlecleucel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03568461

CCTL019E2202

2017-004385-94 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 1 patient group

CTL019

Experimental group

Description:

All patients who received tisagenlecleucel infusion.

Treatment:

Biological: tisagenlecleucel