Actively Recruiting
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)
Led by AbbVie · Updated on 2026-05-13
14
Participants Needed
11
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of Waldenstr�f6m macroglobulinemia or lymphoplasmacytic lymphoma according to WHO classification or consensus panel diagnosis
- At least one prior standard therapy for WM/LPL
- Measurable disease: IgM 500 mg/dL for WM type LPL or measurable node > 1.5 cm or extranodal disease > 1.0 cm by CT scan for others
- Requires systemic anti-cancer treatment for WM/LPL as decided by the investigator
- Eastern Cooperative Oncology Group Performance Status = 2
- Adequate organ and bone marrow function
You will not qualify if you...
- Prior exposure to venetoclax or BCL-2 targeted therapy
- Uncontrolled active systemic infection
- Known bleeding disorders such as von Willebrand's disease or hemophilia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Nagoya City University Hospital /ID# 277580
Nagoya, Aichi-ken, Japan, 467-8602
Actively Recruiting
2
University of Fukui Hospital /ID# 279173
Yoshida-gun, Fukui, Japan, 910-1104
Actively Recruiting
3
Gunma University Hospital /ID# 277576
Maebashi, Gunma, Japan, 371-8511
Actively Recruiting
4
NHO Mito Medical Center /ID# 279175
Higashiibaraki-gun, Ibaraki, Japan, 311-3193
Actively Recruiting
5
University Hospital Kyoto Prefectural University of Medicine /ID# 277584
Kyoto, Kyoto, Japan, 602-8566
Actively Recruiting
6
Kindai University Hospital /ID# 277587
Sakai-shi, Osaka, Japan, 590-0197
Actively Recruiting
7
The University of Tokyo Hospital /ID# 279174
Bunkyo-ku, Tokyo, Japan, 113-8654
Actively Recruiting
8
National Cancer Center Hospital /ID# 279076
Chuo-Ku, Tokyo, Japan, 104-0045
Actively Recruiting
9
National Hospital Organization Disaster Medical Center /ID# 277741
Tachikawa, Tokyo, Japan, 190-0014
Actively Recruiting
10
University of Yamanashi Hospital /ID# 279179
Chuo-shi, Yamanashi, Japan, 409-3898
Actively Recruiting
11
Chiba Cancer Center /ID# 279177
Chiba, Japan, 260-0801
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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