Trials Sponsors Conditions Drugs Pricing

Conditions

Waldenström Macroglobulinemia (WM)

Keywords

zanubrutinibbendamustine

Outcome Measures

Primary Outcomes (1)

Best deep response rate(≥VGPR)
defined as the rate of very good partial response VGPR or CR
up to 1 year

Secondary Outcomes (11)

MRD Negativity Rate at End of Treatment
up to the end of treatment
Duration of Response
up to 3 years
Objective Response Rate (ORR)
up to 1 year
Complete Response (CR) Rate
up to 1 year
Major Response Rate (MRR, ≥ Partial Response)
up to 1 year
+6 more secondary outcomes

Study Arms (1)

Experimental: ZBR

EXPERIMENTAL

Drug: Zaunbrutinib, Bendamustine and Rituximab for induction therapyDrug: Zanubrutinib mono therapy for maintenance treatment

Interventions

Zaunbrutinib, Bendamustine and Rituximab for induction therapyDrug

Patients in the experimental group will receive treatment in 4-week cycles, totaling 4 cycles of zanubrutinib + bendamustine + CD20 Monoclonal Antibody therapy, followed by 8 months of zanubrutinib monotherapy maintenance. Specific regimen: Zanubrutinib: Oral administration starts on Day 1 of Cycle 1 and continues continuously at 160 mg twice daily. Bendamustine: Intravenous infusion at 70 mg/m² on Days 1-2 of Cycles 1-4. CD20 Monoclonal Antibody: Intravenous infusion at 375 mg/m² on Day 0 of Cycles 1-4. After completing the 4-cycle combination therapy, a systematic efficacy evaluation will be conducted.

Experimental: ZBR

Zanubrutinib mono therapy for maintenance treatmentDrug

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Zaunbrutinib, Bendamustine and Rituximab for induction therapy
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record
Treatment programme
Zanubrutinib mono therapy for maintenance treatment
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry record

Eligibility Criteria

Age18 Years - 95 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

\. Male or female patients aged ≥18 years.
\. Must meet the diagnostic criteria for Waldenström's Macroglobulinemia (WM).

Sponsors & Collaborators

Institute of Hematology & Blood Diseases Hospital, China
Otherlead

Study Sites (2)

China Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences

Tianjin, China, 300020, China

Institute of Hematology & Blood Diseases Hospital, China

Tianjin, Tianjin Municipality, 300020, China

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

Bendamustine HydrochlorideRituximabNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

Shuhua Yi
Institute of Hematology & Blood Diseases Hospital, China
PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuhua Yi, Dr

CONTACT

+86-022-23608109 yishuhua@ihcams.ac.cn

Wenjie Xiong

CONTACT

+86-022-23608123

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

December 2, 2025

Study Start

December 30, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

June 30, 2028

Estimated

You may not qualify if:

\. Diagnosis or treatment for any malignancy other than B-cell non-Hodgkin lymphoma (B-NHL) within the past year (including active central nervous system lymphoma).
\. Clinical evidence of transformation to large cell lymphoma.
Pre-existing severe hepatic or renal impairment unrelated to lymphoma: ALT \> 3 × ULN; AST \> 3 × ULN; Total Bilirubin \> 2 × ULN; Estimated creatinine clearance \< 30 mL/min
Any other severe concurrent medical condition that would, in the investigator's judgment, compromise the patient's ability to participate in the study (e.g., uncontrolled diabetes, gastric ulcer, significant cardiac or pulmonary disease, etc.). The final determination rests with the investigator.
\. Known history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotic therapy. Note: Active HBV infection is defined by ALL of the following criteria: a. HBV DNA ≥ 2000 IU/mL; b. ALT ≥ 2 × ULN; c. Hepatitis not attributable to other causes such as the underlying disease or drugs. Patients with initially active HBV who convert to an inactive carrier state after antiviral therapy may be enrolled if they receive adequate concomitant antiviral prophylaxis.
\. Symptomatic central nervous system dysfunction or involvement (Bing-Neel syndrome).
\. Major surgery within 14 days prior to the first dose of study drug or anticipated requirement for major surgery during the study treatment period (excluding lymph node biopsy).
\. Inability to swallow capsules, or conditions significantly affecting gastrointestinal function (e.g., malabsorption syndrome, status post-gastrectomy or small bowel resection, symptomatic inflammatory bowel disease, ulcerative colitis, partial or complete intestinal obstruction).
\. Requirement for concurrent strong Cytochrome P450 (CYP) 3A inhibitors.
\. Pregnancy or lactation. Women of childbearing potential unwilling to use effective contraception during the study period.
\. Known hypersensitivity to any of the study drugs or their excipients.
Withdrawal Criteria
\. Disease progression during treatment (after ≥2 cycles of therapy) or failure to achieve at least a minimal response (MR) after 6 cycles of therapy.
\. Occurrence of intolerable adverse events or complications.
\. Patient's voluntary decision to withdraw consent for continued treatment.
+2 more criteria

A Phase II Clinical Study of Zanubrutinib Combined With Four Cycles of CD20 Monoclonal Antibody and Reduced-Dose Bendamustine in the Treatment of Untreated Waldenström Macroglobulinemia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (1)

Experimental: ZBR

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (1)

Experimental: ZBR

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations