Ignite Creation Date:
2024-05-06 @ 4:02 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04842877
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2021-04-07
Brief Title:
Study of Valemetostat Tosylate as a Single Agent in Patients With RelapseRefractory B-cell Lymphoma
Sponsor:
The Lymphoma Academic Research Organisation
Organization:
The Lymphoma Academic Research Organisation
Study Overview
Official Title:
A Phase II Open-label Study Evaluating Valemetostat Tosylate as a Single Agent in Patients With RelapseRefractory B-cell Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
This is a multicenter prospective single arm non-randomized open-label phase 2 clinical study to evaluate safety and efficacy of valemetostat tosylate DS-3201b in patients with relapsed or refractory B cell lymphoma with 6 cohorts of patients including 2 biology-driven cohorts Up to 141 patients will be enrolled in 6 different cohorts 40 patients with aggressive B-cell lymphoma 41 with follicular lymphoma FL 20 with Mantle Cell Lymphoma MCL and 20 with other indolent lymphomas and 20 patients with Hodgkin lymphoma HL FL patients with EZH2 mutant gain of function mutations will be enrolled in the cohort 2bis At least 8 aggressive B-cell lymphoma patients with EZH2 mutant will be enrolled in the cohort 1 The primary endpoint is the overall response rate ORR determined by investigator assessment
Detailed Description:
Each cycle consists of 28 days Valemetostat tosylate DS-3201b is given continuously at 200 mg once daily QD The total duration is expected to be approximately 3 years assuming an expected enrollment duration of 2 years and a minimum duration of valemetostat tosylate DS- 3201b administration of 12 cycles of 28 days for the last enrolled patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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