Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337318
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-27
Brief Title:
Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase III Study of Mosunetuzumab vs Rituximab for Low Tumor Burden Follicular Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-08
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 III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden Rituximab is a monoclonal antibody It binds to a protein called CD20 which is found on B cells a type of white blood cell and some types of cancer cells This may help the immune system kill cancer cells Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden
Detailed Description:
PRIMARY OBJECTIVES
I To compare the 3-year milestone progression free survival PFS probabilities in participants with previously untreated low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm
II To compare progression free survival PFS in participants with previously untreated low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm
SECONDARY OBJECTIVES
I To compare overall survival OS between participants randomized to rituximab versus mosunetuzumab
II To compare overall response rates at the Week 40 assessment between participants randomized to rituximab versus mosunetuzumab
III To compare event free survival EFS between participants randomized to rituximab versus mosunetuzumab
IV To compare the frequency and severity of toxicities between participants randomized to rituximab versus mosunetuzumab
V To compare the restricted chance of longer PFS 2-6 years between participants randomized to rituximab versus mosunetuzumab
BANKING OBJECTIVE
I To bank specimens for future correlative studies
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive rituximab intravenously IV on day 1 of cycle 1 and receive rituximab and hyaluronidase subcutaneously SC on days 8 15 and 22 of cycle 1 and SC on day 1 of subsequent cycles Cycles repeat every 56 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT scan andor positron emission tomography PETCT and blood sample collection on study and during follow up
ARM II Patients receive mosunetuzumab SC on days 1 8 and 15 of cycle 1 and on day 1 of subsequent cycles Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity Patients undergo CT scan andor PETCT and blood sample collection on study and during follow up
After completion of study treatment patients are followed up every 6 months for 5 years and then yearly for a total of 10 years
I To compare the 3-year milestone progression free survival PFS probabilities in participants with previously untreated low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm
II To compare progression free survival PFS in participants with previously untreated low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm
SECONDARY OBJECTIVES
I To compare overall survival OS between participants randomized to rituximab versus mosunetuzumab
II To compare overall response rates at the Week 40 assessment between participants randomized to rituximab versus mosunetuzumab
III To compare event free survival EFS between participants randomized to rituximab versus mosunetuzumab
IV To compare the frequency and severity of toxicities between participants randomized to rituximab versus mosunetuzumab
V To compare the restricted chance of longer PFS 2-6 years between participants randomized to rituximab versus mosunetuzumab
BANKING OBJECTIVE
I To bank specimens for future correlative studies
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive rituximab intravenously IV on day 1 of cycle 1 and receive rituximab and hyaluronidase subcutaneously SC on days 8 15 and 22 of cycle 1 and SC on day 1 of subsequent cycles Cycles repeat every 56 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT scan andor positron emission tomography PETCT and blood sample collection on study and during follow up
ARM II Patients receive mosunetuzumab SC on days 1 8 and 15 of cycle 1 and on day 1 of subsequent cycles Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity Patients undergo CT scan andor PETCT and blood sample collection on study and during follow up
After completion of study treatment patients are followed up every 6 months for 5 years and then yearly for a total of 10 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 |
|---|---|---|---|
| U10CA180888 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180888 |
| NCI-2024-02361 | REGISTRY | None | None |
| S2308 | OTHER | None | None |
| S2308 | OTHER | None | None |