Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-30 @ 7:02 PM
Study NCT ID:
NCT06723457
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2024-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epcoritamab and Lenalidomide in Treating Patients With Refractory or Relapsed Immunodeficiency-Related Large B-Cell Lymphoma
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
A Phase II Study of Combination Epcoritamab-Lenalidomide in Patients With Refractory/Relapsed Immunodeficiency-Related Large B-Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2025-08
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 the combination of epcoritamab and lenalidomide work in treating patients with immunodeficiency-related large B-cell lymphoma that does not respond to treatment (refractory) or that has come back after a period of improvement (relapsed). Epcoritamab is an immunotherapy that engages T-cells in the immune system to help redirect their killing effects against lymphoma cells. Lenalidomide can modulate the immune system to enhance killing effects of lymphoma by the immune system as well. Giving patients a combination of epcoritamab and lenalidomide may work better in treating refractory or relapsed immunodeficiency-related large B-cell lymphoma.
Detailed Description:
PRIMARY OBJECTIVE:
I. To evaluate the six-month best response of complete response (CR) rate for the combination of epcoritamab-lenalidomide in chemotherapy ineligible patients with primary refractory or relapsed immunodeficiency-related large B-cell lymphoma.
SECONDARY OBJECTIVES:
I. To evaluate the objective response rate (ORR), partial response (PR) and CR rates at 3 (cycle \[C\] 4 day \[D\]1), 6 (C7D1), 12 (30 days post C12), 18 and 24 months for patients on combination epcoritamab-lenalidomide.
II. To assess duration of response (DoR) at 6 (C7D1),12 (30 days post D12), 18 and 24 months for patients on combination epcoritamab-lenalidomide.
III. To assess progression free survival (PFS) with 12,18 and 24 months of follow-up for patients on combination epcoritamab-lenalidomide.
IV. To assess overall survival (OS) with 12, 8 and 24 months of follow-up for patients on combination epcoritamab-lenalidomide.
V. To assess the safety and toxicity of combination epcoritamab-lenalidomide.
EXPLORATORY OBJECTIVES:
I. To assess changes in immune-cell subsets with utilization of epcoritamab-lenalidomide.
II. To evaluate T cell polyfunctionality with the administration of combination epcoritamab-lenalidomide over time.
III. To gain more insights into the phenotype and functional state of different circulating immune cell subsets.
IV. To measure disease-specific symptoms and/or treatment-related concerns in patients treated with combination therapy using Functional Assessment of Cancer Therapy - Lymphoma (FACTLym) European Organization for Research and Treatment of Cancer (EORTC) and Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires.
OUTLINE:
Patients will receive epcoritamab subcutaneously (SC) weekly during cycle 1 and on days 1, 8, 15, and 22 of cycles 2-3, and day 1 of cycles 4-12. Patients will also receive lenalidomide orally (PO) on days 1-21 of each cycle. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients will undergo positron emission tomography (PET)/computed tomography (CT) and collection of blood samples throughout the study and may undergo magnetic resonance imaging (MRI) during screening.
After completion of study treatment, patients will be followed up at 30 days, then at 12, 18 and 24 months.
I. To evaluate the six-month best response of complete response (CR) rate for the combination of epcoritamab-lenalidomide in chemotherapy ineligible patients with primary refractory or relapsed immunodeficiency-related large B-cell lymphoma.
SECONDARY OBJECTIVES:
I. To evaluate the objective response rate (ORR), partial response (PR) and CR rates at 3 (cycle \[C\] 4 day \[D\]1), 6 (C7D1), 12 (30 days post C12), 18 and 24 months for patients on combination epcoritamab-lenalidomide.
II. To assess duration of response (DoR) at 6 (C7D1),12 (30 days post D12), 18 and 24 months for patients on combination epcoritamab-lenalidomide.
III. To assess progression free survival (PFS) with 12,18 and 24 months of follow-up for patients on combination epcoritamab-lenalidomide.
IV. To assess overall survival (OS) with 12, 8 and 24 months of follow-up for patients on combination epcoritamab-lenalidomide.
V. To assess the safety and toxicity of combination epcoritamab-lenalidomide.
EXPLORATORY OBJECTIVES:
I. To assess changes in immune-cell subsets with utilization of epcoritamab-lenalidomide.
II. To evaluate T cell polyfunctionality with the administration of combination epcoritamab-lenalidomide over time.
III. To gain more insights into the phenotype and functional state of different circulating immune cell subsets.
IV. To measure disease-specific symptoms and/or treatment-related concerns in patients treated with combination therapy using Functional Assessment of Cancer Therapy - Lymphoma (FACTLym) European Organization for Research and Treatment of Cancer (EORTC) and Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires.
OUTLINE:
Patients will receive epcoritamab subcutaneously (SC) weekly during cycle 1 and on days 1, 8, 15, and 22 of cycles 2-3, and day 1 of cycles 4-12. Patients will also receive lenalidomide orally (PO) on days 1-21 of each cycle. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients will undergo positron emission tomography (PET)/computed tomography (CT) and collection of blood samples throughout the study and may undergo magnetic resonance imaging (MRI) during screening.
After completion of study treatment, patients will be followed up at 30 days, then at 12, 18 and 24 months.
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-2024-09812 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| STU00222751 | None | None | View | |
| NU 24H07 | OTHER | Northwestern University | View | |
| P30CA060553 | NIH | None | https://reporter.nih.gov/quic… | View |