ZR-CHOP in DLBCL With Specific Gene Abnormality

Overview

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.

Full Title of Study: “Phase 2 Study of Zanubrutinib Plus RCHOP (ZR-CHOP) in Newly Diagnosed Diffuse Large B-cell Lymphoma With Specific Gene Abnormality”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 4, 2024

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.

Interventions

  • Drug: zanubrutinib
    • BTK inhibitor

Arms, Groups and Cohorts

  • Experimental: ZR-CHOP

Clinical Trial Outcome Measures

Primary Measures

  • 3-year progression free survival
    • Time Frame: assessed up to 36 months
    • From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first

Secondary Measures

  • Objective response rate
    • Time Frame: assessed up to 36 months
    • complete remission and partial remission
  • 3-year event free survival
    • Time Frame: assessed up to 36 months
    • From date of enrollment until the date of an event, including progression, death from any cause, new treatment.
  • 3-year overall survival
    • Time Frame: assessed up to 36 months
    • From date of enrollment until the date of death from any cause

Participating in This Clinical Trial

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:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Junning Cao, MD, Principal Investigator – Fudan University

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