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)

Study Identifier
M25-558
CT.gov Identifier
NCT07387471
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Blood Cancer - Non-Hodgkin's Lymphoma (General)
  • Blood Cancer - Lymphoma (General)
    • Study Drug
  • Venetoclax
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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).

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 279178
    Nagoya, Aichi-ken, Japan, 466-8650
    Status
    Recruiting
    Location
    Nagoya City University Hospital /ID# 277580
    Nagoya, Aichi-ken, Japan, 467-8602
    Status
    Recruiting
    Location
    University of Fukui Hospital /ID# 279173
    Yoshida-gun, Fukui, Japan, 910-1104
    Status
    Recruiting
    Location
    Kyushu University Hospital /ID# 277582
    Fukuoka, Fukuoka, Japan, 812-8582
    Status
    Recruiting
    Location
    Gunma University Hospital /ID# 277576
    Maebashi, Gunma, Japan, 371-8511
    Status
    Recruiting
    Location
    Hiroshima University Hospital /ID# 279172
    Hiroshima, Hiroshima, Japan, 734-8551
    Status
    Recruiting
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