RecruitingPhase 2NCT07387471

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)

A Phase 2 Study of Venetoclax Monotherapy in Japanese Subjects With Relapsed or Refractory Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma

Sponsor

AbbVie

Enrollment

14 participants

Start Date

Mar 17, 2026

Study Type

INTERVENTIONAL

Conditions

Waldenstrom Macroglobulinemia Lymphoplasmacytic Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing venetoclax — an oral (pill-form) targeted cancer drug — in people with Waldenström macroglobulinemia (WM) or lymphoplasmacytic lymphoma (LPL), a rare slow-growing blood cancer, that has relapsed (come back) or stopped responding to prior treatments. **You may be eligible if...** - You have a confirmed diagnosis of Waldenström macroglobulinemia or lymphoplasmacytic lymphoma - You have received at least one prior standard treatment - You have measurable disease based on blood protein levels or imaging scans - Your overall health and organ function are adequate (ECOG score of 0–2) - Your cancer currently requires treatment according to your doctor **You may NOT be eligible if...** - You have previously taken venetoclax or another BCL-2 targeted therapy - You have an uncontrolled active infection - You have a known bleeding disorder such as von Willebrand disease or hemophilia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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