ZR-CHOP in DLBCL With Specific Gene Abnormality

NCT05290337 | Unknown Phase 2

• 1 other identifier: ZIDEA
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Zanubrutinib; gene mutation; MYC translocation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Objective response rate

  assessed up to 36 months

• 3-year event free survival

  assessed up to 36 months

• 3-year overall survival

  assessed up to 36 months

Study Arms (1)

ZR-CHOP

EXPERIMENTAL

Drug: zanubrutinib

Interventions

zanubrutinib DRUG

BTK inhibitor

ZR-CHOP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

zanubrutinib

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 22, 2022
• Study Start: January 4, 2022
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2026
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)