Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06068881
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-09-29
Brief Title:
A Study to Assess Efficacy and Safety of Oral Tazemetostat in Adult Participants With RelapsedRefractory Follicular Lymphoma That Does Not Have an EZH2 Gain-of-function Genetic Mutation
Sponsor:
Epizyme Inc
Organization:
Ipsen
Study Overview
Official Title:
A Phase 2 Open-label Single-Arm Clinical Trial to Investigate the Efficacy and Safety of Oral Tazemetostat for the Treatment of Adult Participants Age 18 and Over With RelapsedRefractory Follicular Lymphoma Lacking the EZH2 Gain-of-Function GOF Mutation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mandolin
Brief Summary:
The purpose of this research study is to learn about the effectiveness and safety of the study drug tazemetostat in adults with relapsedrefractory follicular lymphoma whose tumours do not have an EZH2 gain-of-function genetic mutation Follicular lymphoma is a blood cancer It affects white blood cells called lymphocytes White blood cells normally help to fight infections but when you have follicular lymphoma the blood cells can form tumours in your body Relapsedrefractory follicular lymphoma means the disease has either not improved or is getting worse progressing during or after previous treatment
Tazemetostat already has approval in the United States for the treatment of adult patients with relapsedrefractory follicular lymphoma with or without the EZH2 mutation who have no satisfactory alternative treatment options
This study is being conducted to better understand the effectiveness in patients whose tumours do not have an EZH2 gain-of-function genetic mutation and who previously received therapies commonly used in the US in your body
Relapsedrefractory follicular lymphoma means the disease has either not improved or is getting worse progressing during or after previous treatment
Tazemetostat already has approval in the United States for the treatment of adult patients with relapsedrefractory follicular lymphoma with or without the EZH2 gain-of-function mutation who have no satisfactory alternative treatment options This study is being conducted to better understand the effectiveness in patients whose tumours do not have an EZH2 genetic mutation and who previously received therapies commonly used in the US
In this study all participants will receive the study drug It will be taken by mouth orally as a tablet twice daily The sizes and number of tumours according to scan results will be collected as well as results of safety tests such as physical examinations and laboratory tests
The study consists of 4 periods
Screening period may take up to 4 weeks and require at least 1 visit
Treatment period will require 2 visits for each of the first 2 months followed by 1 visit every month for the remainder of the first 12 months followed by 1 visit every 3 months except for women of childbearing potential WOCBP who will continue to have a pregnancy testing every month until unacceptable toxicity disease progression or the start of new systemic anticancer therapy whichever is first
Safety follow-up period will last for 1 month after the last dose of tazemetostat and it will end with 1 visit or telephone call
Long-term follow-up period is only for participants who stop taking tazemetostat while their disease continues to respond this period will last until disease progression start of new cancer treatment or death from any cause whichever is first and will require a visit every 3 months
Tazemetostat will be provided to participants who tolerate it for as long as their disease does not progress
Participants may be transferred to another study or program after about 2 years for continued treatment with tazemetostat or for long-term follow-up Patients may withdraw consent to participate at any time
Tazemetostat already has approval in the United States for the treatment of adult patients with relapsedrefractory follicular lymphoma with or without the EZH2 mutation who have no satisfactory alternative treatment options
This study is being conducted to better understand the effectiveness in patients whose tumours do not have an EZH2 gain-of-function genetic mutation and who previously received therapies commonly used in the US in your body
Relapsedrefractory follicular lymphoma means the disease has either not improved or is getting worse progressing during or after previous treatment
Tazemetostat already has approval in the United States for the treatment of adult patients with relapsedrefractory follicular lymphoma with or without the EZH2 gain-of-function mutation who have no satisfactory alternative treatment options This study is being conducted to better understand the effectiveness in patients whose tumours do not have an EZH2 genetic mutation and who previously received therapies commonly used in the US
In this study all participants will receive the study drug It will be taken by mouth orally as a tablet twice daily The sizes and number of tumours according to scan results will be collected as well as results of safety tests such as physical examinations and laboratory tests
The study consists of 4 periods
Screening period may take up to 4 weeks and require at least 1 visit
Treatment period will require 2 visits for each of the first 2 months followed by 1 visit every month for the remainder of the first 12 months followed by 1 visit every 3 months except for women of childbearing potential WOCBP who will continue to have a pregnancy testing every month until unacceptable toxicity disease progression or the start of new systemic anticancer therapy whichever is first
Safety follow-up period will last for 1 month after the last dose of tazemetostat and it will end with 1 visit or telephone call
Long-term follow-up period is only for participants who stop taking tazemetostat while their disease continues to respond this period will last until disease progression start of new cancer treatment or death from any cause whichever is first and will require a visit every 3 months
Tazemetostat will be provided to participants who tolerate it for as long as their disease does not progress
Participants may be transferred to another study or program after about 2 years for continued treatment with tazemetostat or for long-term follow-up Patients may withdraw consent to participate at any time
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508131-32-00 | OTHER | Epizyme | None |