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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)
Sponsor: AbbVie
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.
Official title: A Phase 2 Study of Venetoclax Monotherapy in Japanese Subjects With Relapsed or Refractory Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
14
Start Date
2026-03-17
Completion Date
2028-07
Last Updated
2026-04-07
Healthy Volunteers
No
Interventions
Venetoclax
Oral
Locations (5)
Nagoya City University Hospital /ID# 277580
Nagoya, Aichi-ken, Japan
Gunma University Hospital /ID# 277576
Maebashi, Gunma, Japan
NHO Mito Medical Center /ID# 279175
Higashiibaraki-gun, Ibaraki, Japan
National Cancer Center Hospital /ID# 279076
Chuo-Ku, Tokyo, Japan
National Hospital Organization Disaster Medical Center /ID# 277741
Tachikawa, Tokyo, Japan