ZR-CHOP in DLBCL With Specific Gene Abnormality

NCT ID: NCT05290337

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2026-01-04

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.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ZR-CHOP

Group Type: EXPERIMENTAL

zanubrutinib

Intervention Type: DRUG

BTK inhibitor

Interventions

zanubrutinib

BTK inhibitor

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Junning Cao, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Qunling Zhang, doctor

Role: primary

zqldoc@163.com

64175590 ext. 88900

Other Identifiers

ZIDEA

Identifier Type: -

Identifier Source: org_study_id