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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy Procedure — PROCEDURE
  Undergo optional tumor biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspiration and biopsy
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow aspiration and biopsy
• Computed Tomography — PROCEDURE
  Undergo CT
• Ibrutinib — DRUG
  Given PO
• Lenalidomide — DRUG
  Given PO
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Obinutuzumab — BIOLOGICAL
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo PET
• Prednisone — DRUG
  Given PO
• Venetoclax — DRUG
  Given PO

Study Details

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.

Key Dates

First listed

Oct 21, 2024

Start date

Oct 7, 2025

Status verified

Aug 2026

Primary completion

Sep 1, 2028

Completion

Sep 1, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (ViPOR)
  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.

Primary Outcome Measure

Complete response (CR) rate (CD10-negative diffuse large B cell lymphoma [DLBCL] and high grade B-cell lymphoma with MYC and BCL2 with or without BCL6 rearrangements [HGBCL-DH-BCL2]) [ Time Frame: Up to 5 years ]

Locations (96)

Find similar trials in Tucson, AZ

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