Study of Tazemetostat in Adults With Follicular Lymphoma Previously Treated With at Least Two Therapies

Ipsen

Status: Begins enrollment in 3 months

Conditions: Follicular Lymphoma

Study type: Observational

Funder types: Industry

Identifiers

NCT07282548

CLIN-60200-456

Details and patient eligibility

About

This study aims to evaluate how well the effectiveness of the medicine Tazemetostat works in adults with relapsed/refractory follicular lymphoma, a slow-growing type of blood cancer that affects a kind of white blood cell called lymphocytes.

All participants will receive Tazemetostat as prescribed by their doctor in the routine clinical practice.

The study will observe how participants respond to the treatment, how long the response lasts, and monitor safety, side effects and how well participants tolerate the treatment.

Full description

The results will be analyzed based on whether or not participants have a mutation in the Enhancer of zeste homolog 2 (EZH2) gene (known as EZH2 wild-type).

Enrollment: 63 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18 years or older
• Histologically confirmed follicular lymphoma grades 1, 2, or 3A
• At least two prior lines of systemic therapy
• Prescribed tazemetostat according to United States prescribing information (USPI)
• Known or planned EZH2 mutation status
• Signed informed consent

Exclusion criteria

• Grade 3B or transformed follicular lymphoma
• Other hematologic malignancies
• Use of strong/moderate Cytochrome P450 (CYP3A) inhibitors
• Pregnant or breastfeeding
• Participation in another investigational program

Trial design

63 participants in 1 patient group

Tazemetostat Monotherapy Group

Description:

Participants with relapsed or refractory follicular lymphoma (grades 1, 2, or 3A) who have received at least two prior lines of systemic therapy and are prescribed tazemetostat monotherapy in accordance with the approved U.S. Prescribing Information. Tazemetostat is administered orally at 800 mg twice daily, as per routine clinical practice. Treatment continues until disease progression, unacceptable toxicity, or other discontinuation criteria are met.