Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649812
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Testing the Effectiveness of a Combination Targeted Therapy ViPOR for Patients With Relapsed andor Refractory Aggressive B-cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study of Venetoclax Ibrutinib Prednisone Obinutuzumab and Revlimid ViPOR in Relapsed or Refractory CD10-Negative Diffuse-Large B-Cell Lymphoma DLBCL and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements HGBCL-DH-BCL2
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:
This phase II trial tests how well venetoclax ibrutinib prednisone obinutuzumab and Revlimid ViPOR works in treating patients with CD10 negative diffuse large B-cell lymphoma DLBCL and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement relapsed andor that has not responded to previous treatment refractory Venetoclax is in a class of medications called B-cell lymphoma-2 BCL-2 inhibitors It may stop the growth of cancer cells by blocking Bcl-2 a protein needed for cancer cell survival Ibrutinib is in a class of medications called kinase inhibitors It blocks a protein called BTK which is present on B-cell a type of white blood cells cancers at abnormal levels This may help keep cancer cells from growing and spreading Anti-inflammatory drugs such as prednisone lower the bodys immune response and are used with other drugs in the treatment of some types of cancer Obinutuzumab a monoclonal antibody binds to a protein called CD20 which is found on B cells and some types of leukemia and lymphoma cells Obinutuzumab may block CD20 and help the immune system kill cancer cells Revlimid a type of anti-angiogenesis agent and a type of immunomodulating agent may help the immune system kill abnormal blood cells or cancer cells It may also prevent the growth of new blood vessels that cancers need to grow ViPOR may be an effective treatment option for patients with relapsed andor refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the complete response CR rate of ViPOR in relapsedrefractory RR
Ia CD10-negative DLBCL and Ib CD10-positive or negative high-grade B-cell lymphoma HGBCL with MYC and BCL2 with or without BCL6 translocations HGBCL-double hit DH-BCL2
SECONDARY OBJECTIVES
I To evaluate the complete response CR rate of ViPOR in relapsedrefractory RR
Ia CD10-negative activated B-cell ABC DLBCL and Ib CD10-negative non-ABC ie unclassified or germinal center B-cell GCB DLBCL
II To evaluate the overall response rate ORR duration of response DOR event-free survival EFS time to progression TTP progression-free survival PFS overall survival OS and the safety toxicity profile of ViPOR in relapsedrefractory RR
IIa CD10-negative ABC DLBCL and IIb CD10-negative non-ABC ie unclassified or GCB DLBCL and IIc CD10-positive or negative HGBCL-DH-BCL2
EXPLORATORY OBJECTIVES
I To assess response and outcome to ViPOR based on molecular DLBCL subtype by cell-of-origin COO testing using Lymph2Cx gene-expression profiling GEP
II To assess response and outcome to ViPOR based on genetic DLBCL subtype by LymphGen classification using whole exome sequencing WES whole genome sequencing WGS and ribonucleic acid RNA-sequencing RNA-seq
III To determine other molecular correlates of response or resistance to ViPOR therapy
IV To determine early molecular correlates of response or resistance as well as the rate of complete molecular remission as determined by assays for circulating-tumor deoxyribonucleic acid DNA ctDNA
OUTLINE
Patients receive venetoclax orally PO once daily QD on days 2-14 ibrutinib PO QD on days 1-14 prednisone PO QD on days 1-7 obinutuzumab intravenously IV on days 1 and 2 and lenalidomide Revlimid PO QD on days 1-14 of each cycle Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection positron emission tomography PET computed tomography CT andor magnetic resonance imaging MRI and optional tumor biopsy and bone marrow aspiration and biopsy throughout the study
After completion of study treatment patients are followed up every 6 months for 2 years yearly during years 3-5 and then for survival for up to 10 years from the date of registration
I To evaluate the complete response CR rate of ViPOR in relapsedrefractory RR
Ia CD10-negative DLBCL and Ib CD10-positive or negative high-grade B-cell lymphoma HGBCL with MYC and BCL2 with or without BCL6 translocations HGBCL-double hit DH-BCL2
SECONDARY OBJECTIVES
I To evaluate the complete response CR rate of ViPOR in relapsedrefractory RR
Ia CD10-negative activated B-cell ABC DLBCL and Ib CD10-negative non-ABC ie unclassified or germinal center B-cell GCB DLBCL
II To evaluate the overall response rate ORR duration of response DOR event-free survival EFS time to progression TTP progression-free survival PFS overall survival OS and the safety toxicity profile of ViPOR in relapsedrefractory RR
IIa CD10-negative ABC DLBCL and IIb CD10-negative non-ABC ie unclassified or GCB DLBCL and IIc CD10-positive or negative HGBCL-DH-BCL2
EXPLORATORY OBJECTIVES
I To assess response and outcome to ViPOR based on molecular DLBCL subtype by cell-of-origin COO testing using Lymph2Cx gene-expression profiling GEP
II To assess response and outcome to ViPOR based on genetic DLBCL subtype by LymphGen classification using whole exome sequencing WES whole genome sequencing WGS and ribonucleic acid RNA-sequencing RNA-seq
III To determine other molecular correlates of response or resistance to ViPOR therapy
IV To determine early molecular correlates of response or resistance as well as the rate of complete molecular remission as determined by assays for circulating-tumor deoxyribonucleic acid DNA ctDNA
OUTLINE
Patients receive venetoclax orally PO once daily QD on days 2-14 ibrutinib PO QD on days 1-14 prednisone PO QD on days 1-7 obinutuzumab intravenously IV on days 1 and 2 and lenalidomide Revlimid PO QD on days 1-14 of each cycle Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection positron emission tomography PET computed tomography CT andor magnetic resonance imaging MRI and optional tumor biopsy and bone marrow aspiration and biopsy throughout the study
After completion of study treatment patients are followed up every 6 months for 2 years yearly during years 3-5 and then for survival for up to 10 years from the date of registration
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