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The RCHOP regimen (rituximab, cyclophosphamide, doxorubicin, vinoredoxin, prednisone) was combined Orelaburutinib treated naive, double-expressing, non-germinal center, diffuse large B cell lymphoma patients: A prospective, multicenter, single arm clinical study

The RCHOP regimen (rituximab, cyclophosphamide, doxorubicin, vinoredoxin, prednisone) was combined Orelaburutinib treated naive, double-expressing, non-germinal center, diffuse large B cell lymphoma patients: A prospective, multicenter, single arm clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090546
Enrollment
Unknown
Registered
2024-10-08
Start date
2021-11-29
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

Diffuse large B-cell lymphoma

Interventions

Experimental group:O-R-CHOP regimen

Sponsors

The First Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1)Double expression of diffuse large B cell lymphoma must be confirmed before enrollment.Diagnostic criteria refer to 2016 WHO subtyping (MYC> 40%, BCL2> 50%). 2) Age 18-70 years; 3) Eastern Oncology (ECOG) fitness score 0-2; 4) subjects must have good organ function; 5) fertile female subjects must use efficient contraception before and during the beginning of the first study administration, until 3 months after the last dose of obrutinib and CHOP, or 12 1)months after the last dose of rituximab, whichever is older.Male subjects were eligible if the vas were removed or if they agreed to combine barrier contraception and other methods during the study period and 3 months after the last administration of the CHOP regimen, or 12 months after the last rituximab administration).7) Life expectancy of 6 months; 8) Voluntary informed consent, leading to understanding and compliance with the study requirements.

Exclusion criteria

Exclusion criteria: 1) Previous systemic treatment with DLBCL 2) Currently with clinically significant active cardiovascular disease such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease determined by the New York Cardiology Association (NYHA) functional classification, or a history of myocardial infarction within 6 months before screening; 3) known human immunodeficiency virus (HIV) infection; 4) pregnant or lactating women; 5) unable to understand, follow the study protocol or sign informed consent;

Design outcomes

Primary

MeasureTime frame
Event-free survival ;

Secondary

MeasureTime frame
Progression-free survival;Overall Survival;Complete response;Safety;Objective response rate;

Countries

China

Contacts

Public ContactZhen Cai

The First Affiliated Hospital of Zhejiang University School of Medicine

2008yy@zju.edu.cn+86 138 5719 0311

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026