ZR-CHOP in DLBCL With Specific Gene Abnormality

Phase 2

Recruiting

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Drug: zanubrutinib

• Registration Number: NCT05290337
• Lead Sponsor: Fudan University

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 abnormality.

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.

Study Timeline

• Study Start: 2022-01-04
• Study First Submitted: 2022-02-10
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-13
• Last Update Submitted: 2022-03-13
• Study First Posted: 2022-03-22
• Last Update Posted: 2022-03-22
• Primary Completion: 2024-01-04
• Study Completion: 2026-01-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZR-CHOP	zanubrutinib	-

Primary Outcome Measures

Name	Time	Method
3-year progression free survival	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 Outcome Measures

Name	Time	Method
Objective response rate	assessed up to 36 months	complete remission and partial remission
3-year event free survival	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	assessed up to 36 months	From date of enrollment until the date of death from any cause

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China