Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536049
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase IbII Trial of Epcoritamab Plus Ibrutinib in Patients With RelapsedRefractory Aggressive B-Cell Non-Hodgkin Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 evaluates the safety optimal dose and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back relapsed or responded to previous treatment refractory Epcoritamab a bispecific antibody binds to two different types of receptors proteins present on the cell surface at the same time The two receptors that epcoritamab binds to are called CD3 and CD20 CD3 is found on T cells which are important cells of the immune system that help fight cancer and infections CD20 is found on the surface of most types of aggressive B-cell non-Hodgkin lymphoma cells By binding to both CD3 and CD20 epcoritamab brings the two cells close together so the T cells can fight and kill the lymphoma B cells Ibrutinib a Brutons tyrosine kinase BTK inhibitor binds to a protein on B cells a type of white blood cell from which the lymphoma developed By doing this it decreases the ability of the lymphoma B cells to survive and grow Ibrutinib may also improve the health or fitness of T cells thus making epcoritamab safer andor more effective
Detailed Description:
PRIMARY OBJECTIVES
I Determine the recommended phase II dose RP2D and safety of epcoritamab plus ibrutinib
II Determine the rate and severity of cytokine release syndrome CRS
SECONDARY OBJECTIVES
I Determine the complete response CR rate Lugano 2014 after cycle 12 or the last dose of treatment if stopped earlier
II Determine the overall response rate ORR CR partial response PR Lugano 2014 progression-free survival PFS duration of response DOR and overall survival OS of patients treated at the RP2D
III Determine the best ORR and CR rate Lugano 2014
EXPLORATORY OBJECTIVES
I Characterize cytokine profile following ibrutinib and epcoritamab and explore whether levels of cytokine production correlate with both the appearance of CRS and ORR
II Analyze peripheral blood mononuclear cells collected pre-ibrutinib pre-epcoritamab and throughout treatment using spectral flow cytometry to assess the effect of ibrutinib on T-cell numbers and function
III Examine tumor samples attained before starting treatment and at relapse and explore aspects of the microenvironment that may contribute to epcoritamab failure
IV Measure circulating tumor deoxyribonucleic acid DNA ctDNA to correlate its presence with response by positron emission tomography PET imaging and track the emergence of treatment-resistant clones
OUTLINE
Patients receive ibrutinib orally PO once daily QD on days -7 to 28 of cycle 1 and on days 1 to 28 of remaining cycles as well as epcoritamab subcutaneously SC on days 1 8 15 and 22 of cycles 1-3 days 1 and 15 of cycles 4-9 and on day 1 of remaining cycles Treatment repeats every 28 days for up to 6 cycles of ibrutinib and up to 12 cycles of epcoritamab in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection computed tomography CT and PETCT throughout the study Patients may also undergo bone marrow aspiration and biopsy on study
After completion of study treatment patients are followed up every 3 months for 2 years then every 6 months for up to 5 years
I Determine the recommended phase II dose RP2D and safety of epcoritamab plus ibrutinib
II Determine the rate and severity of cytokine release syndrome CRS
SECONDARY OBJECTIVES
I Determine the complete response CR rate Lugano 2014 after cycle 12 or the last dose of treatment if stopped earlier
II Determine the overall response rate ORR CR partial response PR Lugano 2014 progression-free survival PFS duration of response DOR and overall survival OS of patients treated at the RP2D
III Determine the best ORR and CR rate Lugano 2014
EXPLORATORY OBJECTIVES
I Characterize cytokine profile following ibrutinib and epcoritamab and explore whether levels of cytokine production correlate with both the appearance of CRS and ORR
II Analyze peripheral blood mononuclear cells collected pre-ibrutinib pre-epcoritamab and throughout treatment using spectral flow cytometry to assess the effect of ibrutinib on T-cell numbers and function
III Examine tumor samples attained before starting treatment and at relapse and explore aspects of the microenvironment that may contribute to epcoritamab failure
IV Measure circulating tumor deoxyribonucleic acid DNA ctDNA to correlate its presence with response by positron emission tomography PET imaging and track the emergence of treatment-resistant clones
OUTLINE
Patients receive ibrutinib orally PO once daily QD on days -7 to 28 of cycle 1 and on days 1 to 28 of remaining cycles as well as epcoritamab subcutaneously SC on days 1 8 15 and 22 of cycles 1-3 days 1 and 15 of cycles 4-9 and on day 1 of remaining cycles Treatment repeats every 28 days for up to 6 cycles of ibrutinib and up to 12 cycles of epcoritamab in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection computed tomography CT and PETCT throughout the study Patients may also undergo bone marrow aspiration and biopsy on study
After completion of study treatment patients are followed up every 3 months for 2 years then every 6 months for up to 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None