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RecruitingNCT05290337Updated Mar 22, 2022

ZR-CHOP in DLBCL With Specific Gene Abnormality

A Phase 2 interventional study of zanubrutinib in Diffuse Large B Cell Lymphoma, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-22.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality.

Read the detailed description

This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality, including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation. all patients received 6 cycle therapy.

02

Conditions studied

  • Diffuse Large B Cell Lymphoma

Keywords

  • Zanubrutinib
  • gene mutation
  • MYC translocation
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 62 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 18-75 years old;
  2. histological confirmed, newly-diagnosed diffuse large B-cell lymphoma with one of the following gene abnormality including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation;
  3. Eastern Cooperative Oncology Group (ECOG) status of 0-1; 4) hospitalized patients and received the whole cycle treatment in Fudan University Shanghai Cancer Center-
  4. normal hematological, hepatic and renal function.
  5. Life expectancy of more than 3 months;
  6. Patients had at least one measurable target lesion;
  7. LVEF ≥ 50%
  8. signed informed consent forms

Exclusion criteria

Exclusion Criteria:

  1. hypersensitivity to immunoglobulin;
  2. primary central nerves lymphoma
  3. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;
  4. With contraindication of steroid including uncontrolled diabetes;
  5. Serious uncontrolled diseases and intercurrent infection;
  6. Pregnant or lactating women;
  7. hepatitis B infection with HBV-DNA ≥ 104
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    ZR-CHOP

    Drug: zanubrutinib

Interventions

  • Drugzanubrutinib

    BTK inhibitor

06

What researchers measure

Primary outcomes

  1. 3-year progression free survival

    From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first

    Time frame: assessed up to 36 months

Secondary outcomes

  1. Objective response rate

    complete remission and partial remission

    Time frame: assessed up to 36 months

  2. 3-year event free survival

    From date of enrollment until the date of an event, including progression, death from any cause, new treatment.

    Time frame: assessed up to 36 months

  3. 3-year overall survival

    From date of enrollment until the date of death from any cause

    Time frame: assessed up to 36 months

07

Study locations

1 of 1 sites recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200032, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05290337
Lead sponsor
Fudan University
Responsible party
Junning Cao, MD (Principal Investigator, Fudan University) — Principal investigator
First posted
Mar 22, 2022
Start date
Jan 4, 2022
Primary completion
Jan 4, 2024 (estimated)
Completion
Jan 4, 2026 (estimated)
Last update
Mar 22, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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