ZR-CHOP in DLBCL With Specific Gene Abnormality

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05290337
• Other study ID #: ZIDEA
• Status: Recruiting
• Phase: Phase 2
• Start date: January 4, 2022
• Est. completion date: January 4, 2026

Study information

• Verified date: March 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: January 4, 2026
• Est. primary completion date: January 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• zanubrutinib
BTK inhibitor

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	assessed up to 36 months
Secondary	Objective response rate	complete remission and partial remission	assessed up to 36 months
Secondary	3-year event free survival	From date of enrollment until the date of an event, including progression, death from any cause, new treatment.	assessed up to 36 months
Secondary	3-year overall survival	From date of enrollment until the date of death from any cause	assessed up to 36 months