Ignite Creation Date:
2024-05-06 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05994235
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-08-08
Brief Title:
Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
A Phase II Trial of Tazemetostat Plus Mosunetuzumab in Untreated Follicular Lymphoma
Status:
RECRUITING
Status Verified Date:
2023-11
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:
The goal of this study is to learn about the safety and effectiveness of the combination of tazemetostat pills in combination with mosunetuzumab injections for people with follicular lymphoma who havent received treatment before The investigators hypothesize that tazemetostat with mosunetuzumab has the potential to increase the efficacy of the product without compromising the safety
Tazemetostat is a drug that inhibits EZH2 an enzyme known to drive the development of B-cell lymphomas and inhibiting it appears to have many effects that slow down lymphoma growth and enhance the immune systems ability to fight it Tazemetostat is FDA-approved in previously treated follicular lymphoma and currently undergoing study in other lymphomas
Mosunetuzumab is a bispecific antibody therapy that is a therapeutic strategy that uses the immune system to fight lymphoma called immunotherapy Bispecific antibodies have two ends one attaches to T cells in the immune system and the other attaches to lymphoma cells helping guide our immune system to attack the cancer Mosunetuzumab has been studied in follicular lymphoma that has previously been treated with positive results Mosunetuzumab is approved by the FDA to be given intravenously directly into a vein but is not yet approved by the FDA is not yet approved as an injection under the skin which is how it is given in this study They have not yet been studied in combination
Tazemetostat is a drug that inhibits EZH2 an enzyme known to drive the development of B-cell lymphomas and inhibiting it appears to have many effects that slow down lymphoma growth and enhance the immune systems ability to fight it Tazemetostat is FDA-approved in previously treated follicular lymphoma and currently undergoing study in other lymphomas
Mosunetuzumab is a bispecific antibody therapy that is a therapeutic strategy that uses the immune system to fight lymphoma called immunotherapy Bispecific antibodies have two ends one attaches to T cells in the immune system and the other attaches to lymphoma cells helping guide our immune system to attack the cancer Mosunetuzumab has been studied in follicular lymphoma that has previously been treated with positive results Mosunetuzumab is approved by the FDA to be given intravenously directly into a vein but is not yet approved by the FDA is not yet approved as an injection under the skin which is how it is given in this study They have not yet been studied in combination
Detailed Description:
This is a phase II open-label study Fifty patients with previously untreated follicular lymphoma will be enrolled and treated with standard dosing of subcutaneous mosunetuzumab and with oral tazemetostat by mouth twice daily at standard dosing 800 mg twice daily beginning at the same time as mosunetuzumab initiation Mosunetuzumab and tazemetostat will be given in 28-day cycles for up to 12 cycles Response assessments by PETCT will occur at 12 weeks post-mosunetuzumab and again at 30 and 48 weeks for those with an ongoing response to treatment Treatment with steroids tocilizumab growth factors tumor lysis prophylaxis and antibiotics may be used as per standard of care at our institution Dose modifications are permitted for toxicity There will be a follow-up visit after 2 years from starting 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 |
|---|---|---|---|
| 22-10025285 | OTHER | WCM IRB | None |