ViPOR Therapy for B-Cell Lymphoma

Recruiting at 57 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Warfarin, Strong CYP3A inhibitors

Disqualifiers: Pregnancy, Primary CNS DLBCL, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

120 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 3 5 6 7}

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

Patient must have measurable disease

Patient must not be pregnant and must follow specific pregnancy testing and contraception guidelines

Patient must meet specific laboratory criteria including ANC, hemoglobin, platelets, bilirubin, AST/ALT, creatinine levels

Exclusion Criteria

I do not have a primary brain lymphoma diagnosis.

I haven't had certain cancer treatments recently.

I haven't had graft-versus-host disease or taken immunosuppressants in the last 28 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid (ViPOR) in cycles of 21 days for up to 6 cycles

18 weeks

Regular visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

2 years with additional yearly follow-ups up to 10 years

Every 6 months for 2 years, then yearly

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?

Group I: Treatment (ViPOR) Experimental Treatment 12 Interventions

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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06649812

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 ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCT04739813

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-with

Phase 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03223610

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.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38899693/

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 ...

7. ecog-acrin.org ecog-acrin.org/clinical-trials/ea4231-b-cell-lymphoma/

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 ...