Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma

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 lym

Trial Details

NCT ID
NCT04840602
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Non-Hodgkin Lymphoma Lymphoma
Interventions
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Computed Tomography
  • Ibrutinib
  • Positron Emission Tomography
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Irvine, California, United States|33.66946,-117.82311
  • Coral Gables, Florida, United States|25.72149,-80.26838
  • Coral Springs, Florida, United States|26.27119,-80.2706

Key Eligibility Criteria

  • Participants must have had a confirmed diagnosis of Waldenstrom's macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL). Participants must have m…
  • IgM Spike: ≥ 500 mg/dL (≥ 5 g/L)
  • Extramedullary disease: The manifestation of a lymphoid mass outside of the bone marrow, resulting in enlargement in extramedullary organs such as …
  • Testing to establish baseline disease status must be performed within 28 days prior to registration

For full eligibility, visit ClinicalTrials.gov.

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