Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06238648
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2024-01-05
Brief Title:
Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy
Sponsor:
Academic and Community Cancer Research United
Organization:
Academic and Community Cancer Research United
Study Overview
Official Title:
Multicenter Randomized Phase II Study of Epcoritamab for Patients With Aggressive B-Cell Lymphomas Achieving a Partial Response After CD19-Directed CAR-T Therapy
Status:
RECRUITING
Status Verified Date:
2024-09
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 compares epcoritamab to standard practice observation for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell CAR-T therapy Epcoritamab is a bispecific antibody It works by simultaneously attaching to a molecule called CD20 on cancerous B-cells and a molecule called CD3 on effector T-cells which are a type of immune cell When epcoritamab binds to CD20 and CD3 it brings the two cells together and activates the T-cells to kill the cancerous B-cells Epcoritamab may increase a patients chances of achieving complete remission after CD19-directed CAR-T therapy compared to standard observation
Detailed Description:
PRIMARY OBJECTIVE
I To compare complete response CR rate using the Lugano 2014 criteria for patients receiving epcoritamab versus observation alone in patients with aggressive B-cell lymphomas who achieved partial response PR post CAR-T therapy
SECONDARY OBJECTIVES
I To compare the progression free survival PFS of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T
II To compare event free survival EFS in patients who receive epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T
III To compare the overall survival OS of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T
IV To compare the duration of response DOR of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T
V To compare the duration of complete response DoCR of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T
VI To compare the time to response TTR of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T
VII To compare the objective response rate ORR of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T
VIII To assess the safety and tolerability of epcoritamab post CAR-T in patients with aggressive B-cell lymphomas
EXPLORATORY OBJECTIVE
I To assess outcomes based on CAR-T line of therapy and costimulatory domain of CAR-T construct
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive epcoritamab subcutaneously SC on days 1 8 15 and 22 of cycles 1-3 days 1 and 15 of cycles 4-9 and day 1 of cycles 10-12 Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo magnetic resonance imaging MRI at screening undergo positron emission tomography PETcomputed tomography CT and collection of blood samples throughout the trial and undergo biopsy at screening and end of treatment Patients may undergo CT or MRI during follow up
ARM B Patients undergo observation per standard care Patients also undergo MRI at screening undergo PETCT and collection of blood samples throughout the trial and undergo biopsy at screening and end of treatment Patients may undergo CT or MRI during follow up
After completion of study treatment patients are followed up every 90 days for 1 year and then every 180 days for up to 5 years post-registration
I To compare complete response CR rate using the Lugano 2014 criteria for patients receiving epcoritamab versus observation alone in patients with aggressive B-cell lymphomas who achieved partial response PR post CAR-T therapy
SECONDARY OBJECTIVES
I To compare the progression free survival PFS of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T
II To compare event free survival EFS in patients who receive epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T
III To compare the overall survival OS of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T
IV To compare the duration of response DOR of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T
V To compare the duration of complete response DoCR of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T
VI To compare the time to response TTR of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T
VII To compare the objective response rate ORR of epcoritamab determined by Lugano 2014 versus observation alone in patients with aggressive B-cell lymphomas post CAR-T
VIII To assess the safety and tolerability of epcoritamab post CAR-T in patients with aggressive B-cell lymphomas
EXPLORATORY OBJECTIVE
I To assess outcomes based on CAR-T line of therapy and costimulatory domain of CAR-T construct
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive epcoritamab subcutaneously SC on days 1 8 15 and 22 of cycles 1-3 days 1 and 15 of cycles 4-9 and day 1 of cycles 10-12 Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo magnetic resonance imaging MRI at screening undergo positron emission tomography PETcomputed tomography CT and collection of blood samples throughout the trial and undergo biopsy at screening and end of treatment Patients may undergo CT or MRI during follow up
ARM B Patients undergo observation per standard care Patients also undergo MRI at screening undergo PETCT and collection of blood samples throughout the trial and undergo biopsy at screening and end of treatment Patients may undergo CT or MRI during follow up
After completion of study treatment patients are followed up every 90 days for 1 year and then every 180 days for up to 5 years post-registration
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 |
|---|---|---|---|
| NCI-2023-10170 | REGISTRY | None | None |
| ACCRU-LY-2201 | OTHER | None | None |
| P30CA015083 | NIH | Academic and Community Cancer Research United | httpsreporternihgovquickSearchP30CA015083 |