A Phase II 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)
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Open
Phase: II
Principal Investigator: Ananth, Snegha
Contact Information:
Katie Bourret
kbourret@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06649812?term=NCT06649812&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVES:
I. To evaluate the complete response (CR) rate of ViPOR in relapsed/refractory (R/R):
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 relapsed/refractory (R/R):
Ia. CD10-negative activated B-cell (ABC) DLBCL; and Ib. CD10-negative non-ABC (i.e., 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 relapsed/refractory (R/R):
IIa. CD10-negative ABC DLBCL; and IIb. CD10-negative non-ABC (i.e., 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).