Zanubrutinib Combined With Standard Chemotherapy in the Treatment for Patients With Diffuse Large B Cell Lymphoma

  • STATUS
    Recruiting
  • End date
    Dec 25, 2025
  • participants needed
    59
  • sponsor
    Henan Cancer Hospital
Updated on 28 January 2021

Summary

This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of zanubrutinib combined with standard chemotherapy in the treatment for patients with diffuse large B cell lymphoma and CD79A/CD79B genetic abnormality.

Description

Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma (NHL). Currently, R-CHOP is world-widely used in the first-line treatment for DLBCL. There are about one second of patients suffering relapse and drug resistance. ABC-DLBCL mainly relies on the chronical activity of BCR signal, which can activate the downstream NF-kB pathway through BTK and MYD88, thereby promoting the occurrence of tumors. A study by Wyndham H Wilson et al. showed that 23% of ABC-DLBCL patients were accompanied by acquired functional mutations of the BCR component CD79A/CD79B. Zanubrutinib is a new BTK inhibitor. The goal of our trial is to assess the efficacy and safety of zanubrutinib combined with standard chemotherapy in the treatment for patients with diffuse large B cell lymphoma and CD79A/CD79B genetic abnormality.

Details
Condition Diffuse Large B-Cell Lymphoma, diffuse large cell lymphoma, diffuse large b cell lymphoma, CD79A Gene Mutation, CD79B Gene Mutation
Treatment Rituximab, cyclophosphamide, prednisone, Epirubicin, vincristine, Zanubrutinib
Clinical Study IdentifierNCT04668365
SponsorHenan Cancer Hospital
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age between 18 to 70 years old (including 18 and 70)
Diagnosed as diffuse large B cell lymphoma
CD79A/CD79B genetic abnormality
Subjects must be untreated or R/R and either a or b (a: medium to high risk/high risk: International Prognostic Index (IPI) score 3-5, aaIPI score 2-3 or NCCN-IPI score 4
Immunohistochemical staining of double expression (BCL2 70% and C-MYC 40%) or P53 protein mutation positive 50%)
Having at least one measurable lesions
World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-1
Life expectancy no less than 3 months
enough main organ function
Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
Agreeing to sign the written informed consents

Exclusion Criteria

Diagnosed as high-grade B-cell lymphoma, including non-specified and double-strike or triple-strike
Diagnosed as grey-zone lymphoma
Diagnosed as primary mediastinal large B-cell lymphoma
Diagnosed as CD20 negative diffuse large B-cell lymphoma
Active malignant tumor need be treated at the same time
Other malignant tumor history
Serious surgery and trauma less than two weeks
Systemic therapy for serious acute/chronic infection
Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
Vaccination with live attenuated vaccine less than 4 weeks
HIV-positive, AIDS patients and untreated active hepatitis
Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
Patients with a history of mental illness
Researchers determine unsuited to participate in this trial
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