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This is a Phase II, Open-label, Multicentre Study of Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma

NCT06427213 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-05-23

No results posted yet for this study

Summary

This is a phase II, open-label, multicentre study of Zanubrutinib-containing regimens in patients with newly diagnosed mantle cell lymphoma.

Conditions

  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin

Interventions

DRUG

Zanubrutinib,Obinutuzumab

Zanubrutinib, 160mg PO BID. C1D17 continuously for 1 year or until progressive disease； Obinutuzumab ：Obinutuzumab will be administered 1,000 mg intravenously on days 1, 8, and 15 of cycle 1, then 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks，up to 20 doses. 1 cycle = 28 days. Maintenance: Zanubrutinib, 160mg PO BID

DRUG

Zanubrutinib and R-BAC

Induction: Zanubrutinib and R-BAC 6 cycles Consolidation: ASCT（If eligible for transplantation），Otherwise, the patient was directly entered into maintenance treatment Maintenance: Zanubrutinib continued until progression

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2027-12-30
Completion
2029-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06427213 on ClinicalTrials.gov