Clinical Trial

Study to Assess Change in Disease Activity of Oral Venetoclax in Adult Participants With Recurring Relapsed or Refractory (R/R) Waldenström Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)

Active, Not Recruiting Phase 2
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Summary
Lymphoplasmacytic Lymphoma (LPL) is a rare type of low-grade B-cell lymphoma. The purpose of this study is to assess the change in disease activity of adult participants with relapsed or refractory Waldenström macroglobulinemia(WM)/LPL receiving venetoclax. Venetoclax is being investigated in the treatment of WM/LPL. Participants will receive oral venetoclax at doses ramping up to the target dose, as part of treatment. Approximately 14 adult participants with WM/LPL will be enrolled in the study at approximately 20 sites in Japan. Participants will receive oral venetoclax at doses ramping up to the target dose. The total study duration is approximately 28 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
Protocol Amendment History 4 changes
critical Enrollment closed, study ongoing 2026-08-01
notable Enrollment increased: 14 -> 16 participants 2026-08-01
notable Trial sites expanded: 11 -> 16 locations 2026-05-20
notable Trial sites expanded: 7 -> 11 locations 2026-05-14
Trial Details
NCT Number NCT07387471
Lead Sponsor AbbVie
Conditions Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
Enrollment 16 participants
Start Date 2026-03-17
Primary Completion 2028-07 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-31