Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-17
Brief Title:
Pirtobrutinib in Combination With Rituximab in Newly Diagnosed Marginal Zone Lymphoma RPirto in Newly Diagnosed MZL
Sponsor:
Narendranath Epperla
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study of Pirtobrutinib in Combination With Rituximab in Newly Diagnosed Marginal Zone Lymphoma A Risk Adapted Approach
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
The purpose of this clinical trial is to learn if the drugs Pirtobrutinib and Rituximab are effective for the treatment of newly diagnosed marginal zone lymphoma
Detailed Description:
PRIMARY OBJECTIVE
I To assess the efficacy of the combination of pirtobrutinib and rituximab based on overall response rate ORR at the end of cycle C 6
SECONDARY OBJECTIVES
I Complete response CR rate at end of C6 II Duration of response DOR III Median and 2-year progression-free survival PFS IV Median and 2-year overall survival OS
EXPLORATORY OBJECTIVES
I To determine the rate of undetectable minimal residual disease uMRD at end of C6 and C12
II To characterize BTK and PLCG2 gene mutations concurrently activated oncogenic pathways and the pharmacodynamic response to treatment from peripheral bone marrow andor tumorlymph node biopsies before and during treatment and after disease progression PD in select patients
OUTLINE
Patients receive pirtobrutinib orally PO once daily QD on days 1-28 and rituximab intravenously IV on day 1 of each cycle Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity After 6 cycles patients with a CR receive pirtobrutinib for an additional 6 cycles and patients with partial response PR or stable disease SD receive pirtobrutinib and rituximab for an additional 6 cycles Patients who then achieve a CR after cycle 12 may continue pirtobrutinib for an additional 6 cycles Patients with a PR or SD after cycle 12 may continue pirtobrutinib until PD Patients also undergo blood sample collection computed tomography CT or positron emission tomography PETCT and PET throughout the study Patients may also undergo tissue biopsy at screening and relapse
After completion of study treatment patients are followed up at 30 days every 3 months up to disease progression or next anticancer treatment then every 6 months
I To assess the efficacy of the combination of pirtobrutinib and rituximab based on overall response rate ORR at the end of cycle C 6
SECONDARY OBJECTIVES
I Complete response CR rate at end of C6 II Duration of response DOR III Median and 2-year progression-free survival PFS IV Median and 2-year overall survival OS
EXPLORATORY OBJECTIVES
I To determine the rate of undetectable minimal residual disease uMRD at end of C6 and C12
II To characterize BTK and PLCG2 gene mutations concurrently activated oncogenic pathways and the pharmacodynamic response to treatment from peripheral bone marrow andor tumorlymph node biopsies before and during treatment and after disease progression PD in select patients
OUTLINE
Patients receive pirtobrutinib orally PO once daily QD on days 1-28 and rituximab intravenously IV on day 1 of each cycle Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity After 6 cycles patients with a CR receive pirtobrutinib for an additional 6 cycles and patients with partial response PR or stable disease SD receive pirtobrutinib and rituximab for an additional 6 cycles Patients who then achieve a CR after cycle 12 may continue pirtobrutinib for an additional 6 cycles Patients with a PR or SD after cycle 12 may continue pirtobrutinib until PD Patients also undergo blood sample collection computed tomography CT or positron emission tomography PETCT and PET throughout the study Patients may also undergo tissue biopsy at screening and relapse
After completion of study treatment patients are followed up at 30 days every 3 months up to disease progression or next anticancer treatment then every 6 months
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03049 | REGISTRY | CTRP Clinical Trial Reporting Program | None |