ViPOR Therapy for B-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination treatment called ViPOR to evaluate its effectiveness for individuals with certain types of aggressive B-cell lymphoma, a form of blood cancer. The treatment combines several drugs that target cancer cells in various ways, such as blocking proteins that aid cancer cell growth or enhancing the immune system to attack cancer cells. The trial seeks patients whose cancer has returned or did not respond to previous treatments and who have specific genetic markers in their cancer. For those with relapsed or treatment-resistant B-cell lymphoma and the specified markers, this trial may be suitable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take warfarin or strong CYP3A inhibitors or inducers within 7 days before joining. Other medications might be allowed, but it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In earlier studies, researchers tested the ViPOR treatment, which includes the drugs venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid, for safety in people with B-cell lymphoma. Research has shown that ViPOR is generally well-tolerated. Some side effects were noted, but they were mostly manageable. For example, some patients experienced low blood cell counts, a common occurrence in cancer treatments, but these were monitored closely.
Reports from these studies also indicate that ViPOR could lead to long-lasting remissions in some patients, helping to prevent the cancer from returning for extended periods. The safety of ViPOR is under careful study, and while risks exist, the treatment has shown promise for those with difficult-to-treat lymphomas.12345Why do researchers think this study treatment might be promising for lymphoma?
Researchers are excited about ViPOR therapy for B-cell lymphoma because it combines several drugs that work together to target the cancer more effectively. Unlike traditional treatments that often focus on a single approach, ViPOR uses a mix of venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid, which work through different mechanisms. This multi-faceted attack aims to improve outcomes by hitting the cancer from multiple angles, potentially leading to better responses and fewer relapses. Additionally, the combination of oral and intravenous administration could enhance patient convenience and adherence.
What evidence suggests that ViPOR might be an effective treatment for B-cell lymphoma?
Research has shown that ViPOR therapy, which combines five drugs, may help treat relapsed or refractory CD10 negative diffuse large B-cell lymphoma (DLBCL). In this trial, participants will receive ViPOR therapy, including Venetoclax, which blocks a protein called BCL-2 that helps cancer cells survive. Another component, Ibrutinib, inhibits a protein called BTK, which aids B-cell cancers in growing and spreading. Obinutuzumab targets a protein called CD20 on cancer cells, assisting the immune system in destroying them. Studies have found that targeting these proteins can help control cancer growth. Early results suggest that using these drugs together can effectively attack multiple survival pathways of B-cell lymphomas.13567
Who Is on the Research Team?
Christopher J Melani
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
This trial is for adults with certain types of aggressive B-cell lymphoma that have not improved or returned after treatment. Eligible patients must have specific subtypes of the disease, such as CD10-negative DLBCL or high-grade B-cell lymphoma with MYC and BCL2 rearrangements, and should have previously undergone a regimen including anthracycline and anti-CD20 antibody. Pregnant individuals or those with primary mediastinal large B-cell lymphoma are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid (ViPOR) in cycles of 21 days for up to 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- ViPOR
Trial Overview
The ViPOR combination therapy being tested includes venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid®. This phase II trial aims to see if this mix can effectively treat relapsed/refractory aggressive B-cell lymphomas by targeting different aspects of cancer cell survival and immune system response.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive venetoclax PO QD on days 2-14, ibrutinib PO QD on days 1-14, prednisone PO QD on days 1-7, obinutuzumab IV on days 1 and 2, and 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, PET, CT and/or MRI and optional tumor biopsy and bone marrow aspiration and biopsy throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Study Details | NCT06649812 | Testing the Effectiveness of ...
ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 ...
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and ...
Objective: To learn if it is safe and effective to give polatuzumab along with venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide to people with ...
3.
ashpublications.org
ashpublications.org/blood/article/142/Supplement%201/434/499484/Phase-Ib-II-Study-of-Multi-Targeted-Therapy-withPhase Ib/II Study of Multi-Targeted Therapy with Venetoclax ...
We developed a 5-drug combination regimen (ViPOR) that targets DLBCL survival sustained by constitutive B-cell receptor (BCR) signaling ( ...
4.
blog-ecog-acrin.org
blog-ecog-acrin.org/now-enrolling-ea4231-for-patients-with-relapsed-or-refractory-b-cell-lymphoma/EA4231 for Patients with Aggressive B-cell Lymphoma
Trial EA4231 is evaluating a new drug combination for patients with B-cell lymphoma that has relapsed after remission or no longer responds ...
Study Details | NCT03223610 | Venetoclax, Ibrutinib ...
ViPOR targets major survival pathways in B-cell lymphomas including BCL-2 (apoptosis); BTK (B-cell receptor signaling and NFKB); Cereblon (NFKB) and CD20.
Combination Targeted Therapy in Relapsed Diffuse Large B ...
Conclusions: Treatment with ViPOR was associated with durable remissions in patients with specific molecular DLBCL subtypes and was associated ...
B-Cell Lymphoma Trial EA4231 Home Page
This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse ...
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