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Lymphoplasmacytic LymphomaCancerProcedureDrugBiologicalPhase 2

What this study is

This phase II trial studies the effects of venetoclax and rituximab in comparison to ibrutinib and rituximab or zanubrutinib in treating patients with previously untreated Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. 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. Zanubrutinib, a type of tyrosine kinase inhibitor, blocks a protein called BTK, which may help keep cancer cells from growing. Giving venetoclax and rituximab may work better in treating patients with previously untreated Waldenstrom's macroglobulinemia than ibrutinib with rituximab or zanubrutinib alone.

What's being tested

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo blood sample collection

  • Bone Marrow Aspiration

    Intervention · PROCEDURE

  • Bone Marrow Biopsy

    Intervention · PROCEDURE

  • Computed Tomography

    Intervention · PROCEDURE

    Undergo CT or PET/CT

  • Ibrutinib

    Intervention · DRUG

  • Positron Emission Tomography

    Intervention · PROCEDURE

    Undergo PET/CT

  • Rituximab

    Intervention · BIOLOGICAL

    Given IV

  • Venetoclax

    Intervention · DRUG

  • Zanubrutinib

    Intervention · DRUG

Both Bone Marrow Aspiration and Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

All of Ibrutinib, Venetoclax, Zanubrutinib

Given PO

Study details

Official title
A Phase II Randomized Study Comparing BTK Inhibitors (Ibrutinib Plus Rituximab or Zanubrutinib Alone) vs. BCL-2 Inhibitor (Venetoclax) and Rituximab in Previously Untreated Waldenström's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)
Sponsor
National Cancer Institute (NCI)
Conditions
Lymphoplasmacytic Lymphoma · Waldenstrom Macroglobulinemia
Enrolling
92 people
Starts
2022-01-05
Est. completion
2028-03-31
Design
Open-label, randomized, crossover, Phase 2
Record
View on ClinicalTrials.gov ↗