UnknownPhase 2

ZR-CHOP in DLBCL With Specific Gene Abnormality

China62 participantsStarted 2022-01-04

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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

What they're measuring

3-year progression free survival

Timeframe: assessed up to 36 months

Trial details

NCT IDNCT05290337

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-04

View on ClinicalTrials.gov More Diffuse Large B Cell Lymphoma trials