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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Zanubrutinib
DrugA potent, specific, and irreversible Bruton tyrosine kinase (BTK) inhibitor
Bendamustine
DrugAlkylating agent
Rituximab
DrugMonoclonal antibody
Treatment groups
65 Participants
are divided into 1 treatment groupGroup A: Zanubrutinib + Bendamustine + RituximabExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Very Good Partial Response (VGPR) or Better Response Rate
Assessed using 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM11) criteria. All participants will be gauged for very good partial response (VGPR) rate or better.
Time frame
Day 1 to 5 years post treatmentSecondary outcomes
1
Treatment Related Adverse Events
Assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. All participants will be followed and assessed for safety and tolerability of the protocol therapy.
Time frame
Day 1 to 5 years post treatment2
Overall Response Rate
Assessed per 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM11) criteria. All participants by mutational status will be monitored for minor response (MR), partial response (PR), very good partial response (VGPR), and complete response (CR).
Time frame
Day 1 to 5 years post treatment3
Major Response Rate
Assessed per 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM11) criteria. All participants by mutational status will be monitored for partial response (PR), very good partial response (VGPR), and complete response (CR).
Time frame
Day 1 to 5 years post treatment4
Complete Response Rate
Assessed per 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM11) criteria. All participants by mutational status will be monitored for having resolution of Waldenstrom's Macroglobulinemia (WM) related symptoms, normalization of serum Immunoglobulin M (IgM) levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. A complete response requires reconfirmation demonstrating normal serum IgM levels, and absence of IgM paraprotein by immunofixation by a measurement repeated at least 2 weeks later.
Time frame
Day 1 to 5 years post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
BeOne Medicines
Collaborator
Source ClinicalTrials.gov