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RECRUITING
NCT07387471
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

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