Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453044
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-30
Brief Title:
Mosunetuzumab and Polatuzumab Vedotin for the Treatment of Patients with Relapsed or Refractory Grade 1-3a Follicular Lymphoma
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Phase 2 Study of Mosunetuzumab with Polatuzumab Vedotin in Patients 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:
None
Brief Summary:
This phase II trial tests how well mosunetuzumab and polatuzumab vedotin works in treating patients with grade 1-3a follicular lymphoma that has come back after a period of improvement relapsed or that has not responded to previous treatment refractory Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread Polatuzumab vedotin is a monoclonal antibody polatuzumab linked to a toxic agent called vedotin Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them Giving mosunetuzumab and polatuzumab vedotin may kill more cancer cells in patients with relapsed or refractory grade 1-3a follicular lymphoma
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate the safety and tolerability of mosunetuzumab plus polatuzumab vedotin in patients with relapsedrefractory RR follicular lymphoma FL Safety lead-in II Estimate the complete response CR rate to mosunetuzumab plus polatuzumab vedotin in RR FL patients Phase II
SECONDARY OBJECTIVES
I Estimate the overall response rate ORR time to first CR time to best response duration of response DOR duration of response among CR DORC progression-free survival PFS overall survival OS and quality of life QOL in RR FL patients treated with mosunetuzumab plus polatuzumab vedotin
II Evaluate the toxicity of mosunetuzumab plus polatuzumab vedotin for RR FL III Examine the use of tocilizumab for cytokine release syndrome CRS in RR FL patients treated with mosunetuzumab plus polatuzumab vedotin
EXPLORATORY OBJECTIVES
I Assess baseline and on-treatment biomarkers and evaluate association with anti-tumor activity and safety
II Examine the type and incidence of CD20 gene mutations downregulation at relapse in RR FL patients treated with mosunetuzumab plus polatuzumab vedotin
OUTLINE
Patients receive polatuzumab vedotin intravenously IV over 30-90 minutes on day 1 of each cycle Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients also receive mosunetuzumab subcutaneously SC on days 1 8 and 15 of cycle 1 and day 1 of remaining cycles Cycles repeat every 21 days for up to 8-17 cycles in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection and computed tomography CT positron emission tomography PETCT or magnetic resonance imaging MRI throughout the study
After completion of study treatment patients are followed up at 30 days and then for 3 years
I Evaluate the safety and tolerability of mosunetuzumab plus polatuzumab vedotin in patients with relapsedrefractory RR follicular lymphoma FL Safety lead-in II Estimate the complete response CR rate to mosunetuzumab plus polatuzumab vedotin in RR FL patients Phase II
SECONDARY OBJECTIVES
I Estimate the overall response rate ORR time to first CR time to best response duration of response DOR duration of response among CR DORC progression-free survival PFS overall survival OS and quality of life QOL in RR FL patients treated with mosunetuzumab plus polatuzumab vedotin
II Evaluate the toxicity of mosunetuzumab plus polatuzumab vedotin for RR FL III Examine the use of tocilizumab for cytokine release syndrome CRS in RR FL patients treated with mosunetuzumab plus polatuzumab vedotin
EXPLORATORY OBJECTIVES
I Assess baseline and on-treatment biomarkers and evaluate association with anti-tumor activity and safety
II Examine the type and incidence of CD20 gene mutations downregulation at relapse in RR FL patients treated with mosunetuzumab plus polatuzumab vedotin
OUTLINE
Patients receive polatuzumab vedotin intravenously IV over 30-90 minutes on day 1 of each cycle Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients also receive mosunetuzumab subcutaneously SC on days 1 8 and 15 of cycle 1 and day 1 of remaining cycles Cycles repeat every 21 days for up to 8-17 cycles in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection and computed tomography CT positron emission tomography PETCT or magnetic resonance imaging MRI throughout the study
After completion of study treatment patients are followed up at 30 days and then for 3 years
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA033572 | NIH | City of Hope Medical Center | httpsreporternihgovquickSearchP30CA033572 |
| NCI-2024-04429 | REGISTRY | None | None |
| 23003 | OTHER | None | None |