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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-12

Study Completion Date

2025-05-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Follicular Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CTL019

All patients who received tisagenlecleucel infusion.

Group Type EXPERIMENTAL

tisagenlecleucel

Intervention Type BIOLOGICAL

Tisagenlecleucel is single infusion.

Interventions

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tisagenlecleucel

Tisagenlecleucel is single infusion.

Intervention Type BIOLOGICAL

Other Intervention Names

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CTL019

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No