Phase II Study of ViPOR Combination Therapy for Adults With Relapsed or Refractory Aggressive CD10-Negative Diffuse Large B-Cell and High-Grade B-Cell Lymphomas

What this Trial Is About

Researchers are evaluating a combination targeted therapy called ViPOR for patients with relapsed or refractory aggressive B-cell lymphoma, specifically CD10-negative diffuse large B-cell lymphoma DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements. This phase II trial aims to measure how well ViPOR works in treating these lymphomas by assessing complete response rates and other clinical outcomes. The study also explores molecular and genetic factors that may influence treatment response or resistance using advanced gene-expression profiling and sequencing techniques. Participants receive a combination of venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide Revlimid in 21-day cycles for up to six cycles, provided the disease does not progress or toxicity becomes unacceptable. Venetoclax, ibrutinib, prednisone, and lenalidomide are given orally on specific days of each cycle, while obinutuzumab is administered intravenously on the first two days. Throughout the study, patients undergo blood sample collection, PET scans, CT or MRI imaging, and may optionally have tumor biopsies and bone marrow aspiration and biopsy. During the study, participants are closely monitored with imaging and laboratory tests to evaluate treatment response and safety. After completing treatment, follow-up visits occur every six months for two years, then yearly for years three to five, and continued survival monitoring for up to ten years from registration. Researchers measure outcomes such as complete response rate, overall response, duration of response, progression-free survival, and overall survival, while also tracking adverse effects associated with the therapy.

Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma