ZR-CHOP in DLBCL With Specific Gene Abnormality

Fudan University62 enrolled

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, including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation. all patients received 6 cycle therapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diffuse Large B Cell Lymphoma

Interventions

zanubrutinibDRUG

BTK inhibitor

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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

Objective response rate

complete remission and partial remission

Time frame: assessed up to 36 months

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-year overall survival

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

Time frame: assessed up to 36 months

Data from ClinicalTrials.gov

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