Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT06572618
Status:
RECRUITING
Last Update Posted:
2025-03-05
First Post:
2024-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nemtabrutinib With Rituximab for the Treatment of Patients With Mantle Cell Lymphoma
Sponsor:
City of Hope Medical Center
Organization:
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:
RECRUITING
Status Verified Date:
2025-03
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 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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-06740 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 23421 | OTHER | City of Hope Medical Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |