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

NCT ID: NCT07282548

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-06-30

Study Completion Date

2031-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Follicular Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tazemetostat Monotherapy Group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Central Contacts

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Ipsen Clinical Study Enquiries

Role: CONTACT

See email

Other Identifiers

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CLIN-60200-456

Identifier Type: -

Identifier Source: org_study_id

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