Oral venetoclax for adults with relapsed or refractory Waldenström macroglobulinemia/lymphoplasmacytic lymphoma
A Phase 2 Study of Venetoclax Monotherapy in Japanese Subjects With Relapsed or Refractory Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma
This will try oral venetoclax in adults with relapsed or refractory Waldenström macroglobulinemia or lymphoplasmacytic lymphoma to see if it reduces disease activity.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 11 sites (Nagoya, Aichi-ken and 10 other locations) |
| Trial ID | NCT07387471 on ClinicalTrials.gov |
What this trial studies
This open-label Phase 2 study will give oral venetoclax with a dose ramp-up to a target dose to about 14 adult participants with relapsed or refractory WM/LPL at multiple sites in Japan. Participants must have measurable disease and prior therapy and will be followed with regular clinic visits, blood tests, imaging, and safety assessments over a study period of roughly 28 months. Investigators will monitor changes in disease activity and adverse events to characterize response and tolerability. The trial is sponsored by AbbVie and enrolls at regional university hospitals in Japan.
Who should consider this trial
Good fit: Adults with a confirmed WM/LPL diagnosis who have received at least one prior standard therapy, have measurable disease, require systemic treatment, and have adequate organ function and ECOG performance status ≤2 are ideal candidates.
Not a fit: Patients who do not have measurable disease, do not require systemic therapy, have poor organ function or performance status, or have contraindications to venetoclax are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, venetoclax could reduce disease activity and provide an additional oral treatment option for adults with relapsed or refractory WM/LPL.
How similar studies have performed: Venetoclax has shown activity in other B-cell malignancies and small WM/LPL case series, but large randomized evidence in WM/LPL is limited.
Eligibility criteria
Show full inclusion / 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).
Where this trial is running
Nagoya, Aichi-ken and 10 other locations
- Nagoya City University Hospital /ID# 277580 — Nagoya, Aichi-ken, Japan (Recruiting)
- University of Fukui Hospital /ID# 279173 — Yoshida-gun, Fukui, Japan (Recruiting)
- Gunma University Hospital /ID# 277576 — Maebashi, Gunma, Japan (Recruiting)
- NHO Mito Medical Center /ID# 279175 — Higashiibaraki-gun, Ibaraki, Japan (Recruiting)
- University Hospital Kyoto Prefectural University of Medicine /ID# 277584 — Kyoto, Kyoto, Japan (Recruiting)
- Kindai University Hospital /ID# 277587 — Sakai-shi, Osaka, Japan (Recruiting)
- The University of Tokyo Hospital /ID# 279174 — Bunkyo-ku, Tokyo, Japan (Recruiting)
- National Cancer Center Hospital /ID# 279076 — Chuo-Ku, Tokyo, Japan (Recruiting)
- National Hospital Organization Disaster Medical Center /ID# 277741 — Tachikawa, Tokyo, Japan (Recruiting)
- University of Yamanashi Hospital /ID# 279179 — Chuo-shi, Yamanashi, Japan (Recruiting)
- Chiba Cancer Center /ID# 279177 — Chiba, Japan (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.