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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

2026-05-29

Healthy Volunteers

No

Interventions

DRUG

Venetoclax

Oral

Locations (17)

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 279178

Nagoya, Aichi-ken, Japan

Nagoya City University Hospital /ID# 277580

Nagoya, Aichi-ken, Japan

University of Fukui Hospital /ID# 279173

Yoshida-gun, Fukui, Japan

Kyushu University Hospital /ID# 277582

Fukuoka, Fukuoka, Japan

Gunma University Hospital /ID# 277576

Maebashi, Gunma, Japan

Hiroshima University Hospital /ID# 279172

Hiroshima, Hiroshima, Japan

NHO Mito Medical Center /ID# 279175

Higashiibaraki-gun, Ibaraki, Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 277584

Kyoto, Kyoto, Japan

Kindai University Hospital /ID# 277587

Sakai-shi, Osaka, Japan

The University of Tokyo Hospital /ID# 279174

Bunkyo-ku, Tokyo, Japan

National Cancer Center Hospital /ID# 279076

Chuo-Ku, Tokyo, Japan

The Cancer Institute Hospital Of JFCR /ID# 277579

Koto-ku, Tokyo, Japan

Japanese Red Cross Medical Center /ID# 277577

Shibuya-ku, Tokyo, Japan

National Hospital Organization Disaster Medical Center /ID# 277741

Tachikawa, Tokyo, Japan

University of Yamanashi Hospital /ID# 279179

Chuo-shi, Yamanashi, Japan

Chiba Cancer Center /ID# 279177

Chiba, Japan

Nagano Red Cross Hospital /ID# 279774

Nagano, Japan