Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06357676
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-02
Brief Title:
Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Phase IbII Study Evaluating the Clinical Activity of Glofitamab Plus Ibrutinib GLIB With Obinutuzumab Pretreatment in Previously Untreated Mantle Cell Lymphoma in Patients 65 or Ages 18-64 With High-Risk Features
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 IBII trial tests the safety side effects and effectiveness of glofitamab plus ibrutinib with obinutuzumab for the treatment of patients with mantle cell lymphoma MCL Glofitamab is in a class of medications called bispecific monoclonal antibodies It works by killing cancer cells A monoclonal antibody is a type of protein that can bind to certain targets in the body such as molecules that cause the body to make an immune response antigens In the body glofitamab binds to a receptor called CD3 on T-cells a type of immune cells and a receptor called CD20 on B-cells a receptor that is often over-expressed on the surface of cancerous B-cells When glofitamab binds to CD3 and CD20 receptors it causes an immune response against the CD20-expressing cancerous B-cells Ibrutinib is in a class of medications called kinase inhibitors It works by blocking the action of the abnormal protein that signals cancer cells to multiply This helps stop the spread of cancer cells Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread Glofitamab plus ibrutinib with obinutuzumab may be safe tolerable andor effective in treating patients with MCL
Detailed Description:
PRIMARY OBJECTIVES
I Determine the safety and tolerability of treatment with glofitamab and ibrutinib GLIB for previously untreated MCL in patients with high risk or age 65 yrs Phase Ib I Determine the efficacy of treatment with GLIB for previously untreated MCL in patients with high risk or age 65 yrs Phase II
SECONDARY OBJECTIVES
I Assess the overall acute toxicity and tolerability of treatment with GLIB II Assess the preliminary efficacy of treatment with GLIB based on clinical response
III Assess survival in the absence of progressive disease recurrence of disease or death due to any cause after treatment with GLIB
IV Assess the duration of clinical response and complete response to treatment with GLIB
EXPLORATORY OBJECTIVES
I Evaluate response to treatment evaluated as minimal residual disease MRD II Evaluate the differential impact of treatment on T cell populations in the tumor microenvironment
OUTLINE
Patients receive ibrutinib orally PO once daily QD on days 1-21 of cycles 1-17 Cycles repeat every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity Patients receive glofitamab intravenously IV over 2-4 hours on days 8 and 15 of cycle 2 and then on day 1 of cycles 3-13 Cycles repeat every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity Patients also receive obinutuzumab IV over 4 hours at least 7 days and 24 hours prior to first dose of glofitamab Additionally patients undergo echocardiography during screening bone marrow biopsy on study and computed tomography CT scans fludeoxyglucose F-18 FDG positron emission tomography PETcomputed tomography CT scans or magnetic resonance imaging MRI and blood sample collection throughout the study
After completion of study treatments patients are followed up every 3 months for up to 2 years
I Determine the safety and tolerability of treatment with glofitamab and ibrutinib GLIB for previously untreated MCL in patients with high risk or age 65 yrs Phase Ib I Determine the efficacy of treatment with GLIB for previously untreated MCL in patients with high risk or age 65 yrs Phase II
SECONDARY OBJECTIVES
I Assess the overall acute toxicity and tolerability of treatment with GLIB II Assess the preliminary efficacy of treatment with GLIB based on clinical response
III Assess survival in the absence of progressive disease recurrence of disease or death due to any cause after treatment with GLIB
IV Assess the duration of clinical response and complete response to treatment with GLIB
EXPLORATORY OBJECTIVES
I Evaluate response to treatment evaluated as minimal residual disease MRD II Evaluate the differential impact of treatment on T cell populations in the tumor microenvironment
OUTLINE
Patients receive ibrutinib orally PO once daily QD on days 1-21 of cycles 1-17 Cycles repeat every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity Patients receive glofitamab intravenously IV over 2-4 hours on days 8 and 15 of cycle 2 and then on day 1 of cycles 3-13 Cycles repeat every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity Patients also receive obinutuzumab IV over 4 hours at least 7 days and 24 hours prior to first dose of glofitamab Additionally patients undergo echocardiography during screening bone marrow biopsy on study and computed tomography CT scans fludeoxyglucose F-18 FDG positron emission tomography PETcomputed tomography CT scans or magnetic resonance imaging MRI and blood sample collection throughout the study
After completion of study treatments patients are followed up every 3 months for up to 2 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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01208 | REGISTRY | None | None |
| STUDY00025355 | OTHER | OHSU Knight Cancer Institute | None |