AzTrials
AzTrials

Diffuse Large B Cell LymphomaPhase 2NCT04668365

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

A Phase 2 study testing Rituximab, Zanubrutinib and Cyclophosphamide in people with Diffuse Large B Cell Lymphoma and CD79A Gene Mutation, run by Henan Cancer Hospital at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Rituximab, Zanubrutinib and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteChina
Study dates
25 Dec 2020to 25 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

    Zhengzhou, Henan

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Rituximab, Zanubrutinib, Cyclophosphamide, Epirubicin, Vincristine
Keywords
Diffuse Large B Cell Lymphoma, Zanubrutinib, CD79A/CD79B, Genetic Abnormality
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Congenital Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called RiTUXimab Injection

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

  • ZanubrutinibDrug

    Also called Zanubrutinib Pill

    160mg twice daily continuous oral administration.

  • CyclophosphamideDrug

    Also called Cyclophosphamide Injection

    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.

  • EpirubicinDrug

    Also called Epirubicin Injection

    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.

  • VincristineDrug

    Also called Vincristine Injection

    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.

  • PrednisoneDrug

    Also called Prednisone Pill

    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.

Study groups in NCT04668365
Study groupRoleWhat they receive
Zanubrutinib Combined With Standard ChemotherapyExperimentalA: 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.
Receives: Drug: Rituximab; Drug: Zanubrutinib; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vincristine; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. objective response rate

    the total proportion of patients with complete response (CR) and partial response (PR)

    Measured: 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. 2-year progression-free survival

    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

    Measured: 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)

  3. 2-year overall survival

    from date of first day of treatment to the date of death by any cause

    Measured: 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)

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

    the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2020
  2. Study start25 Dec 2020
  3. Primary completion20 Nov 2024
  4. Study completion25 Dec 2025 (estimated)

Why it stopped: Data in analysis

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04668365
Sponsor's protocol ID
HNSZLYYNHL05
Status last verified
Apr 2025
First submitted
8 Dec 2020
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab, Zanubrutinib and Cyclophosphamide in people with Diffuse Large B Cell Lymphoma and CD79A Gene Mutation, run by Henan Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04668365.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in