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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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 203 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 2 of 145 sites
  2. Study sites: 144 to 145
  3. Trial sites expanded: 138 → 143 locations Eligibility criteria shortened, about 10 words · Secondary endpoints: details revised at 2 of 6 entries Show 2 more changesShow less
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints: details revised at 2 of 6 entries
  4. Study sites: 138 to 143v200
  5. Site details revised at 2 of 138 sitesv199
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 136 to 138v198
  2. Study sites: 135 to 136v197
  3. Study sites: 134 to 135v196
  4. Study sites: 133 to 134v195
  5. Site details revised at 2 of 133 sitesv194
  6. Study sites: 131 to 133v193
  7. Study sites: 130 to 131v192
  8. Study sites: 129 to 130v191
  9. Study sites: 128 to 129v190
  10. Site details revised at 2 of 128 sitesv189
  11. Study sites: 126 to 128v188
  12. Study sites: 125 to 126v187
  13. 25 versions Re-verified since Mar 7, 2026, no change to tracked fieldsv162-v186
  14. Site details revised at 2 of 125 sitesv161
  15. 2 versions Re-verified since Mar 4, 2026, no change to tracked fieldsv159-v160
  16. Trial status: Suspended to Recruiting Study sites: 113 to 125v158 Show 1 more changeShow less
    • Study sites: 113 to 125
  17. Interventions: Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)…v157
  18. 3 versions Re-verified since Feb 11, 2026, no change to tracked fieldsv154-v156
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04840602
Lead Sponsor National Cancer Institute (NCI)
Conditions Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov