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)

May 27, 2026 updated by: AbbVie

A Phase 2 Study of Venetoclax Monotherapy in Japanese Subjects With Relapsed or Refractory Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Chiba, Japan, 260-0801
        • Recruiting
        • Chiba Cancer Center /ID# 279177
      • Nagano, Japan, 380-8582
        • Recruiting
        • Nagano Red Cross Hospital /ID# 279774
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital /ID# 277580
      • Nagoya, Aichi-ken, Japan, 466-8650
        • Recruiting
        • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 279178
    • Fukui
      • Yoshida-gun, Fukui, Japan, 910-1104
        • Recruiting
        • University of Fukui Hospital /ID# 279173
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital /ID# 277582
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Recruiting
        • Gunma University Hospital /ID# 277576
    • Hiroshima
      • Hiroshima, Hiroshima, Japan, 734-8551
        • Recruiting
        • Hiroshima University Hospital /ID# 279172
    • Ibaraki
      • Higashiibaraki-gun, Ibaraki, Japan, 311-3193
        • Recruiting
        • NHO Mito Medical Center /ID# 279175
    • Kyoto
      • Kyoto, Kyoto, Japan, 602-8566
        • Recruiting
        • University Hospital Kyoto Prefectural University of Medicine /ID# 277584
    • Osaka
      • Sakai-shi, Osaka, Japan, 590-0197
        • Recruiting
        • Kindai University Hospital /ID# 277587
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8654
        • Recruiting
        • The University of Tokyo Hospital /ID# 279174
      • Chuo-Ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital /ID# 279076
      • Koto-ku, Tokyo, Japan, 135-8550
        • Recruiting
        • The Cancer Institute Hospital Of JFCR /ID# 277579
      • Shibuya-ku, Tokyo, Japan, 150-8935
        • Recruiting
        • Japanese Red Cross Medical Center /ID# 277577
      • Tachikawa, Tokyo, Japan, 190-0014
        • Recruiting
        • National Hospital Organization Disaster Medical Center /ID# 277741
    • Yamanashi
      • Chuo-shi, Yamanashi, Japan, 409-3898
        • Recruiting
        • University of Yamanashi Hospital /ID# 279179

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Venetoclax Monotherapy
Participants will receive venetoclax at doses ramping up to the target dose, as part of the approximately 28 month study duration.
Drug: Venetoclax
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Major Response
Time Frame: Up to Approximately 28 Months
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
Time Frame: Up to Approximately 28 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to Approximately 28 Months
PFS is defined as time from first study treatment to a documented disease progression (PD) according to IWWM-11 criteria, determined by investigator or death from any cause, whichever occurs first.
Up to Approximately 28 Months
Overall Survival (OS)
Time Frame: Up to Approximately 28 Months
OS is defined as time from first study treatment to death due to any cause.
Up to Approximately 28 Months
Overall Response (OR)
Time Frame: Up to Approximately 28 Months
For participants with IgM >= 500 mg/dL at screening, overall response is defined as participants with a best overall response of CR, VGPR, PR or minor response (MR) per investigator assessment according to IWWM-11 criteria. For participants with IgM < 500 mg/dL at screening, overall response is defined as participants with the best overall response of CR or PR per investigator assessment according to Revised Response Criteria for Malignant Lymphoma.
Up to Approximately 28 Months
Duration of Response (DOR)
Time Frame: Up to Approximately 28 Months
For participants with IgM >= 500 mg/dL at screening, DOR is defined as time from the initial response of CR, VGPR or PR per investigator review according to IWWM-11 criteria to PD or death of any cause, whichever occurs first. For participants with IgM < 500 mg/dL at screening, DOR is defined as time from the initial response of CR or PR per investigator review according to Revised Response Criteria for Malignant Lymphoma to PD or death of any cause, whichever occurs first. DOR will be summarized for the participants achieving overall response.
Up to Approximately 28 Months
Time to Next Treatment (TTNT)
Time Frame: Up to Approximately 28 Months
TTNT is defined as time from first study treatment to the starting date of new anti-cancer therapy.
Up to Approximately 28 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M25-558

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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