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

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) and/or 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 body's 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 and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.

Conditions

• High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements
• Recurrent Diffuse Large B-Cell Lymphoma
• Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
• Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
• Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
• Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified
• Recurrent T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
• Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
• Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
• Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified
• Refractory T-Cell/Histiocyte-Rich Large B-Cell Lymphoma

Interventions

PROCEDURE

Biopsy Procedure

Undergo optional tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Ibrutinib

Given PO

DRUG

Lenalidomide

Given PO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Obinutuzumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET

DRUG

Prednisone

Given PO

DRUG

Venetoclax

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Christopher J Melani · ECOG-ACRIN Cancer Research Group

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-07

Primary Completion

2027-09-01

Completion

2027-09-01

FDA Drug

Yes

Countries

• United States

Study Locations