NCT05979948 (CZ-WM01) is a Phase 2 clinical trial of Zanubrutinib in Waldenström's Macroglobulinemia, sponsored by Shanghai Changzheng Hospital.

Who is sponsoring NCT05979948?

NCT05979948 is sponsored by Shanghai Changzheng Hospital.

What drugs are being tested in NCT05979948?

Interventions in NCT05979948: Zanubrutinib, Bendamustine, Rituximab.

What condition does NCT05979948 study?

NCT05979948 studies Waldenström's Macroglobulinemia.

Is NCT05979948 still recruiting?

NCT05979948 is currently status unknown. Last updated 14 September 2023.

Last reviewed 2023-09-14 · How we verify

NCT05979948: CZ-WM01

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2 Clinical Trial to Evaluate Zanubrutinib Combined With BR (Bendamustine/Rituximab) Regimen in Subjects With Newly-diagnosed Waldenström's Macroglobulinemia

Status unknown Phase 2 Last updated 14 September 2023

What this trial tests

Phase 2 trial testing Zanubrutinib in Waldenström's Macroglobulinemia in 60 participants. Status unknown.

Timeline

1 August 2023

Primary endpoint
1 April 2025

1 December 2025

Quick facts

Lead sponsor	Shanghai Changzheng Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 August 2023
Primary completion	1 April 2025
Estimated completion	1 December 2025
Sites	1 location across China

Drugs / interventions tested

Zanubrutinib (ZANUBRUTINIB) — full drug profile →
Bendamustine (BENDAMUSTINE) — full drug profile →
Rituximab — full drug profile →

Conditions studied

Waldenström's Macroglobulinemia — all drugs for Waldenström's Macroglobulinemia →

Sponsor

Shanghai Changzheng Hospital

Who can join

Adults 18 to 75, any sex, with Waldenström's Macroglobulinemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This was a single-arm, multicenter, Phase 2 study to evaluate the efficacy of zanubrutinib combined with BR (Bendamustine/Rituximab) regimen in Chinese participants with newly-diagnosed Waldenström's macroglobulinemia who exhibited one or more of the criteria for requiring treatment based on consensus guidelines from the 11th International Workshop on Waldenström's Macroglobulinemia (IWWM). The investigators propose this combination will improve the deep remission compared to single Zanubrutinib or BR regimen and can be a time-limited regimen which will reduce the life-time therapy and benefit the patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Optimal use of BTK inhibitors in Waldenström's macroglobulinemia: combination or single drug approach?
Solia E, Kastritis E. · · 2024 · PMID 39734591 · DOI 10.1177/20406207241308771

Verify or expand the search:

Other trials of Zanubrutinib

Trials testing the same drug.

NCT07341191 — Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR · Phase 2 · not yet recruiting
NCT06859008 — Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Rel · Phase 1 · recruiting
NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07321652 — Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated C · Phase 3 · not yet recruiting
NCT07283965 — Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies · not yet recruiting

Other recruiting trials for Waldenström's Macroglobulinemia

Currently open trials in the same condition.

NCT07169331 — A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglob · Phase 4 · recruiting
NCT03697356 — R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia · Phase 2 · recruiting

Other Shanghai Changzheng Hospital trials

Trials by the same sponsor.

NCT07527884 — The Effect of Radiotherapy After Separation Surgery for Spinal Metastases · NA · not yet recruiting
NCT07527728 — Postoperative Neurological Recovery and Risk Factor Analysis in Patients With Paralysis Due to Spinal Metastases · not yet recruiting
NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases · EARLY_PHASE1 · recruiting
NCT07398326 — Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer · Phase 2 · recruiting
NCT07381257 — Efficacy and Safety of Rifaximin-α in Treating MASLD · EARLY_PHASE1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05979948 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Changzheng Hospital
Last refreshed: 14 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05979948.

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