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)

Official record

Identifier

NCT07387471

Recruiting locations

country

Japan

Interventions studied

Venetoclax

Lead sponsor

AbbVie

Target enrolment

16 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Active, not recruiting

First posted

Feb 4, 2026

Last updated on the registry

Jul 31, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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).