A clinical study on the efficacy and safety of R-CHOP/BR+Zanubrutinib in the first-line treatment of young mantle cell lymphoma

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200055483

Enrollment

Unknown

Registered

2022-01-10

Start date

2022-01-10

Completion date

Unknown

Last updated

2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Experimental group :R-CHOP/BR+zanubrutinib

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. No gender limit, aged 18-65 years. 2. Pathologically confirmed MCL with proven chromosomal translocation t( 11; 14) (q 13; q32) and/or overexpression of cyclin D1 with other relevant markers (eg CD5, CD19, CD20, PAX5). 3. MCL requiring treatment and no prior systemic therapy. 4. Presence of radiographically measurable lymph node disease and/or extranodal malignant lymphoma. 5. Eastern Cooperative Oncology Group (ECOG) performance status <= 2. 6. Willing and able to participate in all necessary assessments and procedures in this study protocol, including no difficulty in swallowing capsules. 7. Be able to understand the purpose and risks of the research, provide signed and dated informed consent, and be able to authorize the use of protected health information (in accordance with national and local patient privacy regulations).

Exclusion criteria

Exclusion criteria: 1. Indolent mantle cell lymphoma; 2. Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, and creatinine > 3 times the upper limit of normal); 3. Uncontrolled active infection; 4. The existence of structural heart disease, which leads to clinical symptoms or abnormal cardiac function (NYHA >= grade 2); 5. There are other tumors at the same time; 6. Other psychological conditions that prevent patients from participating in the research or signing the informed consent.

Design outcomes

Primary

Measure	Time frame
blood routine;liver function;PET-CT;	—

Secondary

Measure	Time frame
electrolyte;	—

Countries

China

Contacts

Public ContactHuang Haiwen

The First Affiliated Hospital of Soochow University

huanghaiwen@suda.edu.cn+86 13962154846

Outcome results