Nemtabrutinib, Bortezomib, and Rituximab for WM
ConditionWaldenstrom Macroglobulinemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital
About this trial
This is a phase II (2 parts), open-label, single arm, multicenter study to evaluate the efficacy and safety of nemtabrutinib in combination with bortezomib and rituximab
Eligibility criteria
Qualifiers
Confirmed diagnosis of WM in accordance with the consensus panel of the IWWM (per local evaluation), and treatment naïve
Symptomatic disease meeting at least 1 of the recommendations from the IWWM for requiring treatment.
Measurable disease defined as serum monoclonal IgM > 0.5g/dL.
Is an individual of any sex/gender, who are at least 19 years of age on the day of signing informed consent (ICF).
Disqualifiers
Active HBV/HCV infection.
Positive for human immunodeficiency virus (HIV).
Gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy).
Active infection requiring systemic therapy, including IV antibiotics during screening. Participants may be rescreened followed completion of IV antibiotic course.
Trial design
Treatments tested in this trial
- NEBULA
Treatment groups
19 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov