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NCT Number: NCT07387471

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)

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.

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Key information

Conditions

Waldenstrom Macroglobulinemia Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Non-Hodgkin Lymphoplasmacytic Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 279178, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Venetoclax

Drug

Oral

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 4, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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