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

NCT04668365 | Suspended Phase 2 DMC

• 1 other identifier: HNSZLYYNHL05
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diffuse Large B Cell Lymphoma; CD79A Gene Mutation; CD79B Gene Mutation

Keywords

Diffuse Large B Cell Lymphoma; Zanubrutinib; CD79A/CD79B; Genetic Abnormality

Outcome Measures

Primary Outcomes (1)

• Proportion of complete remission for 3-4 weeks after induction treatment

  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 Outcomes (4)

• objective response rate

  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)

• 2-year progression-free survival

  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)

• 2-year overall survival

  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)

• incidence and relationship with study drugs of grade 3-4 adverse events

  from the date of the first cycle of treatment to 18 months after last patient's enrollment (each cycle is 21 days)

Study Arms (1)

Zanubrutinib Combined With Standard Chemotherapy

EXPERIMENTAL

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; Drug: Zanubrutinib; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vincristine; Drug: Prednisone

Interventions

Rituximab DRUG

375mg/m2, Intravenous administration on day 0 of each 3-week cycle.

Also known as: RiTUXimab Injection

Zanubrutinib Combined With Standard Chemotherapy

Zanubrutinib DRUG

160mg twice daily continuous oral administration.

Also known as: Zanubrutinib Pill

Zanubrutinib Combined With Standard Chemotherapy

Cyclophosphamide DRUG

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.

Also known as: Cyclophosphamide Injection

Zanubrutinib Combined With Standard Chemotherapy

Epirubicin DRUG

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.

Also known as: Epirubicin Injection

Zanubrutinib Combined With Standard Chemotherapy

Vincristine DRUG

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.

Also known as: Vincristine Injection

Zanubrutinib Combined With Standard Chemotherapy

Prednisone DRUG

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.

Also known as: Prednisone Pill

Zanubrutinib Combined With Standard Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 to 75 years old (including 18 and 75)
• Diagnosed as diffuse large B cell lymphoma
• CD79A/CD79B genetic abnormality
• Subjects with untreated or relapsed/refractory DLBCL
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Congenital Abnormalities

Interventions

Rituximab; zanubrutinib; Cyclophosphamide; Epirubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Zhihua Yao, M.D. Ph.D

  Henan Cancer Hospital

  STUDY DIRECTOR

• Yanyan Liu, M.D. Ph.D

  Henan Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: December 25, 2020
• Primary Completion: November 20, 2024
• Study Completion: December 25, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

CN (1)