Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572618
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Nemtabrutinib With Rituximab for the Treatment of Patients With Mantle Cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study of BTK Inhibitor Nemtabrutinib in Combination With Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 phase II trial tests how well nemtabrutinib works with rituximab for the treatment of patients with mantle cell lymphoma Nemtabrutinib is in a class of medications called kinase inhibitors It blocks a protein called BTK which is present on B-cell a type of white blood cells cancers such as mantel cell lymphoma at abnormal levels This may help keep cancer cells from growing and spreading 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 Giving nemtabrutinib with rituximab may kill more cancer cells in patients with mantle cell lymphoma
Detailed Description:
PRIMARY OBJECITVE
I To evaluate the efficacy complete response rate of nemtabrutinib and rituximab Nem-R in patients with treatment-naïve mantle cell lymphoma MCL
SECONDARY OBJECITVES
I To evaluate objective response rate ORR median progression-free survival PFS overall survival OS and duration of response DOR
II To evaluate safety and tolerability of Nem-R in patients with treatment-naïve MCL
EXPLORATORY OBJECITVES
I To conduct preliminary assessment of the predictive value of minimal residual disease MRD in MCL treated with a novel regimen
II To explore immune cell populations in patients treated with Nem-R III To explore mechanisms of resistance to Nem-R therapy in MCL IV To estimate the second PFS after salvage therapy for patients who progress after Nem-R therapy
OUTLINE
INDUCTION Patients receive nemtabrutinib orally PO once per day QD on days 1-28 of each cycle and rituximab intravenously IV on days 1 8 15 and 22 of cycle 1 and on day 1 of subsequent cycles Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity
MAINTENANCE Patients receive nemtabrutinib PO QD on days 1-28 of each cycle and rituximab IV on day 1 of event numbered cycles Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity Patients may optionally continue to receive nemtabrutinib PO QD in the absence of disease progression or unacceptable toxicity
Patients undergo bone marrow biopsy during screening and may undergo throughout the trial and positron emission tomography-computed tomography PET-CT scan and blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days then every 3 months for the first 2 years and every 6 months for the third year for patients in remission at the end of treatment or every 6 months for patients who end response follow up
I To evaluate the efficacy complete response rate of nemtabrutinib and rituximab Nem-R in patients with treatment-naïve mantle cell lymphoma MCL
SECONDARY OBJECITVES
I To evaluate objective response rate ORR median progression-free survival PFS overall survival OS and duration of response DOR
II To evaluate safety and tolerability of Nem-R in patients with treatment-naïve MCL
EXPLORATORY OBJECITVES
I To conduct preliminary assessment of the predictive value of minimal residual disease MRD in MCL treated with a novel regimen
II To explore immune cell populations in patients treated with Nem-R III To explore mechanisms of resistance to Nem-R therapy in MCL IV To estimate the second PFS after salvage therapy for patients who progress after Nem-R therapy
OUTLINE
INDUCTION Patients receive nemtabrutinib orally PO once per day QD on days 1-28 of each cycle and rituximab intravenously IV on days 1 8 15 and 22 of cycle 1 and on day 1 of subsequent cycles Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity
MAINTENANCE Patients receive nemtabrutinib PO QD on days 1-28 of each cycle and rituximab IV on day 1 of event numbered cycles Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity Patients may optionally continue to receive nemtabrutinib PO QD in the absence of disease progression or unacceptable toxicity
Patients undergo bone marrow biopsy during screening and may undergo throughout the trial and positron emission tomography-computed tomography PET-CT scan and blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days then every 3 months for the first 2 years and every 6 months for the third year for patients in remission at the end of treatment or every 6 months for patients who end response follow up
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