Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594939
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicenter Phase II Study of Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This single-arm interventional phase 2 study is designed to evaluate whether the inclusion of mosunetuzumab subcutaneous and polatuzumab vedotin Mosun-Pola to a split-dose CHP chemotherapy backbone will improve outcomes for elderly patients with a new diagnosis of diffuse large B-cell lymphoma
Detailed Description:
This trial combines two novel agents mosunetuzumab subcutatneous and polatuzumab vedotin Mosun-Pola with cytotoxic chemotherapy while allowing de-escalation in rapidly responding patients After completing the first two cycles of Mosun-Pola-SD-CHP therapy subjects will undergo an interim response assessment with positron emission tomography PET computed tomography CT and minimal residual disease MRD testing ClonoSEQ Adaptive Biotechnology prior to Cycle 3A Patients who are interim PET-negative and MRD-negative will be placed on an abbreviated treatment regimen where they will receive Mosun-Pola-SD-CHP therapy for only four cycles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None