Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM
ConditionWaldenstrom Macroglobulinemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
The purpose of this study is to determine the very good partial response (VGPR) or better rate in participants with Waldenström macroglobulinemia (WM).
The names of the study drugs involved in this study are as follows: zanubrutinib, bendamustine, and rituximab.
Eligibility criteria
Qualifiers
Clinicopathological diagnosis of waldenström macroglobulinemia (WM) per the second international workshop on waldenström macroglobulinemia (IWWM2) criteria
Presence of any MYD88 and CXCR4 mutation status, including MYD88 L265P mutation plus CXCR4 wild type, MYD88 L265P mutation plus CXCR4 mutation, or MYD88 wild type
Constitutional Symptoms (at least one of the following)
Recurrent fever
Disqualifiers
Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness/social condition that would prevent the participant from signing the informed consent form
Female participants who are pregnant, breastfeeding, or planning to become pregnant or breastfeed while enrolled in this study
Participants with known CNS involvement by WM
Participants with known history of Human Immunodeficiency Virus (HIV)
Trial design
Treatments tested in this trial
- Zanubrutinib
- Bendamustine
- Rituximab
Treatment groups
56 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
BeOne Medicines
Collaborator
Source ClinicalTrials.gov