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
1 other identifier
interventional
16
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2026
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2026
CompletedFirst Posted
Study publicly available on registry
February 4, 2026
CompletedStudy Start
First participant enrolled
March 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
July 31, 2026
July 1, 2026
2.3 years
January 28, 2026
July 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants with Major Response
Major response is defined as participants with a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR) per independent review committee (IRC) assessment according to International Workshop on Waldenstrom macroglobulinemia (WM) (IWWM)-11 criteria in participants with Immunoglobulin M (IgM) \>= 500 mg/dL at screening.
Up to Approximately 28 Months
Number of Participants with Major Response in participants with IgM >= 500 mg/dL
Major response is defined as participants with a best overall response of CR, VGPR or PR per IRC assessment according to IWWM-11.
Up to Approximately 28 Months
Secondary Outcomes (5)
Progression-Free Survival (PFS)
Up to Approximately 28 Months
Overall Survival (OS)
Up to Approximately 28 Months
Overall Response (OR)
Up to Approximately 28 Months
Duration of Response (DOR)
Up to Approximately 28 Months
Time to Next Treatment (TTNT)
Up to Approximately 28 Months
Study Arms (1)
Venetoclax Monotherapy
EXPERIMENTALParticipants will receive venetoclax at doses ramping up to the target dose, as part of the approximately 28 month study duration.
Interventions
Eligibility Criteria
You may qualify if:
- Documented diagnosis of Waldenström macroglobulinemia(WM) /lymphoplasmacytic lymphoma (LPL) according to the 5th edition of the World Health Organization (WHO) classification and/or documented clinicopathological diagnosis of WM in accordance with the consensus panel of the second International Workshop on WM (IWWM).
- At least one prior standard therapy for WM/LPL.
- Measurable disease, defined as follows:
- WM type LPL population: Immunoglobulin M (IgM) \>= 500 mg/dL per central laboratory (approximately 14 participants)
- Non-IgM type LPL population or IgM \< 500 mg/dL: A measurable node having a longest diameter (LDi) greater than 1.5 cm, or a measurable extranodal disease having a LDi greater than 1.0 cm, according to contrast-enhanced computed tomography (CT) scan. (up to 2 participants)
- Requires systemic anti-cancer treatment for WM/LPL, according to the investigator.
- Eastern Cooperative Oncology Group Performance Status \< = 2
- Adequate organ and bone marrow function
You may not qualify if:
- History of prior exposure to venetoclax or BCL-2 targeted therapy.
- Uncontrolled active systemic infection.
- Known bleeding disorders (e.g., von Willebrand's disease or hemophilia).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (17)
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 279178
Nagoya, Aichi-ken, 466-8650, Japan
Nagoya City University Hospital /ID# 277580
Nagoya, Aichi-ken, 467-8602, Japan
University of Fukui Hospital /ID# 279173
Yoshida-gun, Fukui, 910-1104, Japan
Kyushu University Hospital /ID# 277582
Fukuoka, Fukuoka, 812-8582, Japan
Gunma University Hospital /ID# 277576
Maebashi, Gunma, 371-8511, Japan
Hiroshima University Hospital /ID# 279172
Hiroshima, Hiroshima, 734-8551, Japan
NHO Mito Medical Center /ID# 279175
Higashiibaraki-gun, Ibaraki, 311-3193, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 277584
Kyoto, Kyoto, 602-8566, Japan
Kindai University Hospital /ID# 277587
Sakai-shi, Osaka, 590-0197, Japan
The University of Tokyo Hospital /ID# 279174
Bunkyo-ku, Tokyo, 113-8654, Japan
National Cancer Center Hospital /ID# 279076
Chuo-Ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital Of JFCR /ID# 277579
Koto-ku, Tokyo, 135-8550, Japan
Japanese Red Cross Medical Center /ID# 277577
Shibuya-ku, Tokyo, 150-8935, Japan
National Hospital Organization Disaster Medical Center /ID# 277741
Tachikawa, Tokyo, 190-0014, Japan
University of Yamanashi Hospital /ID# 279179
Chuo-shi, Yamanashi, 409-3898, Japan
Chiba Cancer Center /ID# 279177
Chiba, 260-0801, Japan
Nagano Red Cross Hospital /ID# 279774
Nagano, 380-8582, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2026
First Posted
February 4, 2026
Study Start
March 17, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.