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

April 23, 2025 updated by: Zhihua Yao, PhD, Henan Cancer Hospital

A Single Arm, Multi-center, Phase II Clinical Trial of Zanubrutinib Combined With Standard Chemotherapy in the Treatment for Patients With Diffuse Large B Cell Lymphoma and CD79A/CD79B Genetic Abnormality

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18 to 75 years old (including 18 and 75)
  2. Diagnosed as diffuse large B cell lymphoma
  3. CD79A/CD79B genetic abnormality
  4. Subjects with untreated or relapsed/refractory DLBCL
  5. Having at least one measurable lesions
  6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-1
  7. Life expectancy no less than 3 months
  8. enough main organ function
  9. 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
  10. Agreeing to sign the written informed consents

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zanubrutinib Combined With Standard Chemotherapy

A: For the first-line treatment:

Rituximab, 375mg/m2, Intravenous administration on day 0, combined with regimen：CHOP (Cyclophosphamide, Epirubicin, Vincristine and Prednisone): repeated every 3 weeks, up to 6 cycles.

Zanubrutinib, 160mg twice daily continuous oral administration from 2 to 6 cycles for patients with CD79A/CD79B genetic abnormality.

Zanubrutinib combined with Rituximab for the 7 cycle.

B: For R/R DBCLC:

Rituximab, 375mg/m2, Intravenous administration on day 0, combined with regimen: GemOx(Gemcitabine, Oxaliplatin)/ DHAP(Cisplatin, Cytarabine, Dexamethasone)/ ICE(Ifosfamide, Etoposide, Carboplatin)/ GDP(Gemcitabine, Cisplatin, Dexamethasone): repeated every 3 weeks, up to 5 cycles.

Zanubrutinib, 160mg twice daily continuous oral administration from 2 to 5 cycles for patients with CD79A/CD79B genetic abnormality.

Maintenance treatment: Zanubrutinib, 160mg twice daily continuous oral administration for 12 months.
Drug: Rituximab
375mg/m2, Intravenous administration on day 0 of each 3-week cycle.
Other Names:
  • RiTUXimab Injection
Drug: Zanubrutinib
160mg twice daily continuous oral administration.
Other Names:
  • Zanubrutinib Pill
Drug: Cyclophosphamide
750mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, disease progression after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
Other Names:
  • Cyclophosphamide Injection
Drug: Epirubicin
70mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, disease progression after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
Other Names:
  • Epirubicin Injection
Drug: Vincristine
1.4mg/m2 (Max: 2mg), Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, disease progression after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
Other Names:
  • Vincristine Injection
Drug: Prednisone
100mg, oral administration on day 1 to 5 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, disease progression after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
Other Names:
  • Prednisone Pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of complete remission for 3-4 weeks after induction treatment
Time Frame: from the date of the first cycle of treatment to 3-4 weeks after induction treatment of the last included patient (each cycle is 21 days)
the total proportion of patients with complete remission (CR) for 3-4 weeks after induction treatment
from the date of the first cycle of treatment to 3-4 weeks after induction treatment of the last included patient (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year progression-free survival
Time Frame: from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment (each cycle is 21 days)
the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first
from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment (each cycle is 21 days)
objective response rate
Time Frame: every 6 weeks from the day of the first cycle of induction chemotherapy treatment and every 8 weeks from the day of the first cycle of maintenance treatment to 18 months after last patient's enrollment (each cycle is 21 days)
the total proportion of patients with complete response (CR) and partial response (PR)
every 6 weeks from the day of the first cycle of induction chemotherapy treatment and every 8 weeks from the day of the first cycle of maintenance treatment to 18 months after last patient's enrollment (each cycle is 21 days)
incidence and relationship with study drugs of grade 3-4 adverse events
Time Frame: from the date of the first cycle of treatment to 18 months after last patient's enrollment (each cycle is 21 days)
the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03)
from the date of the first cycle of treatment to 18 months after last patient's enrollment (each cycle is 21 days)
2-year overall survival
Time Frame: from date of the first cycle of treatment to the date of death from any cause, assessed up to 2 years (each cycle is 21 days)
from date of first day of treatment to the date of death by any cause
from date of the first cycle of treatment to the date of death from any cause, assessed up to 2 years (each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Investigators

  • Study Director: Yanyan Liu, M.D. Ph.D, Henan Cancer Hospital
  • Study Director: Zhihua Yao, M.D. Ph.D, Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2020

Primary Completion (Actual)

November 20, 2024

Study Completion (Estimated)

December 25, 2025

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (Actual)

December 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNSZLYYNHL05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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