Status:

UNKNOWN

ZR-CHOP in DLBCL With Specific Gene Abnormality

Lead Sponsor:

Fudan University

Conditions:

Diffuse Large B Cell Lymphoma

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief 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 ab...

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 ab...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 4 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 4 2026

Estimated Enrollment :

62 Patients enrolled

Trial Details

Trial ID

NCT05290337

Start Date

January 4 2022

End Date

January 4 2026

Last Update

March 22 2022

Active Locations (1)

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1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032