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New treatment option for Waldenstrom Macroglobulinemia
Official title 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)
ClinicalTrials.gov ID: NCT07387471
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for waldenstrom macroglobulinemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented diagnosis of Waldenström macroglobulinemia(WM) /lymphoplasmacytic lymphoma (LPL) according to the 5th edition of the World Health...
- 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...
You likely can't join 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).
See the full eligibility 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...
- 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...
- 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
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Nagoya, Aichi-ken, Japan
- Yoshida-gun, Fukui, Japan
- Fukuoka, Fukuoka, Japan
- Maebashi, Gunma, Japan
- Hiroshima, Hiroshima, Japan
- Higashiibaraki-gun, Ibaraki, Japan
- Kyoto, Kyoto, Japan
- Sakai-shi, Osaka, Japan
- Bunkyo-ku, Tokyo, Japan
- Chuo-Ku, Tokyo, Japan
- Koto-ku, Tokyo, Japan
- Shibuya-ku, Tokyo, Japan
- Tachikawa, Tokyo, Japan
- Chuo-shi, Yamanashi, Japan
- Chiba, Japan
- Nagano, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nagoya, Aichi-ken, Japan; Yoshida-gun, Fukui, Japan; Fukuoka, Fukuoka, Japan; Maebashi, Gunma, Japan; Hiroshima, Hiroshima, Japan; Higashiibaraki-gun, Ibaraki, Japan and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.