Ignite Creation Date:
2024-05-06 @ 2:07 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04224493
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2019-12-12
Brief Title:
A Study to Assess the Efficacy Safety Pharmacodynamics and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With RelapsedRefractory Follicular Lymphoma
Sponsor:
Epizyme Inc
Organization:
Ipsen
Study Overview
Official Title:
Symphony-1 A Phase 1b3 Double-Blind Randomized Active-Controlled 3-Stage Biomarker Adaptive Study Of Tazemetostat Or Placebo In Combination With Lenalidomide Plus Rituximab In Subjects With RelapsedRefractory Follicular Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-09
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:
SYMPHONY-1
Brief Summary:
The participants of this study would have relapsedrefractory follicular lymphoma
Follicular lymphoma is a type of blood cancer It is referred to as relapsed when the disease has come back after a period of improvement after that follows a treatment regimen and refractory when treatment no longer works
Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated known as tolerability It is also designed to establish a recommended study drug dosage for stage 2 and 3 Stage 1 of the study is completed
Stages 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo dummy drug in combination with other drug treatment
Follicular lymphoma is a type of blood cancer It is referred to as relapsed when the disease has come back after a period of improvement after that follows a treatment regimen and refractory when treatment no longer works
Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated known as tolerability It is also designed to establish a recommended study drug dosage for stage 2 and 3 Stage 1 of the study is completed
Stages 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo dummy drug in combination with other drug treatment
Detailed Description:
Stage 1 is a safety run-in phase was designed to evaluate the safety of the combination of tazemetostat and R2 as well as to establish the RP3D for Stage 2 which is now completed
Stage 2 is an efficacy and safety phase for an assessment of the FL population with the enhancer of zeste homolog 2 EZH2 gain-of-function GOF mutation EZH2 mutant-type MT and without the EZH2 GOF mutation EZH2 wild-type WT In Stage 2 EZH2 WT and EZH2 MT patients will be randomly assigned in a 11 ratio to tazemetostat R2 or placebo R2 There will be 1 futility interim analysis IA and 1 efficacy IA for WT population and 1 efficacy IA for MT population
Stage 3 is a long-term follow-up of patients for assessment of response and overall survival All patients will be followed for survival until 5 years post last patient enrolled in the study
Stage 2 is an efficacy and safety phase for an assessment of the FL population with the enhancer of zeste homolog 2 EZH2 gain-of-function GOF mutation EZH2 mutant-type MT and without the EZH2 GOF mutation EZH2 wild-type WT In Stage 2 EZH2 WT and EZH2 MT patients will be randomly assigned in a 11 ratio to tazemetostat R2 or placebo R2 There will be 1 futility interim analysis IA and 1 efficacy IA for WT population and 1 efficacy IA for MT population
Stage 3 is a long-term follow-up of patients for assessment of response and overall survival All patients will be followed for survival until 5 years post last patient enrolled in the study
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 |
|---|---|---|---|
| 2024-510690-16-00 | CTIS | None | None |
| 2019-003333-42 | EUDRACT_NUMBER | None | None |