ZR-CHOP in DLBCL With Specific Gene Abnormality

  • STATUS
    Recruiting
  • End date
    Jan 4, 2026
  • participants needed
    62
  • sponsor
    Fudan University
Updated on 14 April 2022
Accepts healthy volunteers

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.

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.

Details
Condition Diffuse Large B Cell Lymphoma
Treatment Zanubrutinib
Clinical Study IdentifierNCT05290337
SponsorFudan University
Last Modified on14 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

18-75 years old
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
Eastern Cooperative Oncology Group (ECOG) status of 0-1; 4) hospitalized patients and received the whole cycle treatment in Fudan University Shanghai Cancer Center-
normal hematological, hepatic and renal function
Life expectancy of more than 3 months
Patients had at least one measurable target lesion
LVEF ≥ 50%
signed informed consent forms

Exclusion Criteria

hypersensitivity to immunoglobulin
primary central nerves lymphoma
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
With contraindication of steroid including uncontrolled diabetes
Serious uncontrolled diseases and intercurrent infection
Pregnant or lactating women
hepatitis B infection with HBV-DNA ≥ 104
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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