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OncoMatch/Clinical Trials/NCT05914662

Zanubrutinib Plus BR in Newly Diagnosed Symptomatic WM

Is NCT05914662 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Zanubrutinib, Bendamustine and Rituximab for waldenstrom macroglobulinemia.

Phase 2RecruitingInstitute of Hematology & Blood Diseases Hospital, ChinaNCT05914662Data as of May 2026

Treatment: Zanubrutinib, Bendamustine and RituximabThis study aims to evaluate the long-term efficacy of BTK inhibitor Zanubrutinib combined bendamustine and rituximab (ZBR) for time-limited treatment of Waldenstrom macroglobulinemia, The combination therapy is expected to improve the remission depth, prolong the remission time, and improve the progression-free survival and overall survival of newly diagnosed WM patients. On the one hand, the patients have to bear a long-term economic burden, which is often difficult for some patients to adhere to for a long time. On the other hand, in the course of long-term treatment of BTKi, drug resistance and intolerable side effects are prone to occur. At the same time, it can prevent the disease rebound after the withdrawal of BTKi, so as to achieve the phased withdrawal of WM

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: BTK inhibitor

No combined chemotherapy with BTKi

Cannot have received: BR

No combined chemotherapy with BR

Cannot have received: RCD

No combined chemotherapy with RCD

Cannot have received: VRD

No combined chemotherapy with VRD

Cannot have received: CHOP

No combined chemotherapy with CHOP

Cannot have received: COP

No combined chemotherapy with COP

Cannot have received: fludarabine-containing regimen (fludarabine)

No treatment regimen containing fludarabine

Cannot have received: chlorambucil (chlorambucil)

Exception: less than 4 weeks (alone or in combination with adrenal glucocorticoids), and did not reach the treatment response (MR)

Chlorambucil or cyclophosphamide for less than 4 weeks (alone or in combination with adrenal glucocorticoids); The above treatment did not reach the treatment response (MR)

Cannot have received: cyclophosphamide (cyclophosphamide)

Exception: less than 4 weeks (alone or in combination with adrenal glucocorticoids), and did not reach the treatment response (MR)

Chlorambucil or cyclophosphamide for less than 4 weeks (alone or in combination with adrenal glucocorticoids); The above treatment did not reach the treatment response (MR)

Lab requirements

Blood counts

neutrophils ≥ 0.75×10^9/l; platelets ≥ 50×10^9/l

Kidney function

creatinine clearance rate ≥ 30ml/min

Liver function

total bilirubin ≤ 2.5 times upper limit; alanine aminotransferase/aspartate aminotransferase ≤3 times upper limit

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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