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A randomized controlled study of comparing the efficacy and safety of Pegylated liposmal doxorubicin, Epirubicin and Doxorubicin in Diffuse large B cell lymphoma

A randomized controlled study of comparing the efficacy and safety of Pegylated liposmal doxorubicin, Epirubicin and Doxorubicin in Diffuse large B cell lymphoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16008631
Enrollment
Unknown
Registered
2016-06-12
Start date
2016-07-01
Completion date
Unknown
Last updated
2017-04-18

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

one:R-CDOP protocol
two:R-CEOP protocol
three:R-CHOP protocol

Sponsors

Union Hospital,Tongji Medical College,Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients must meet the following criteria for study entry: 1. All patients must be Confirmed as diffuse large B cell lymphoma by pathology or histocytology and suitable for CHOP-like regimen; 2. Aged 18 to 65 years old; 3. ECOG performance status of 0 to 2; 4. All patients did not receive other treatment associated with lymphoma; 5. Patient have at least one measurable lesions; 6. Life expectancy more than 3 months; 7. Adequate hematologic and hepatic-renal function: White Blood Cell>=3000/uL,Absolute neutrophil >=1500/uL,Hemoglobin >=100g/L,Platelet >=75×109/L,ALT <=Upper limit of normal 2 times, AST <=Upper limit of normal 2 times, TBil <=Upper limit of normal 1.5 times; 8. LVEF should be 45% or higher measured by two-dimensional echocardiography or MUGA scans; 9. Heart function class for I–II according New York heart association (NYHA); 10.Ability and willingness to comply with the study protocol.

Exclusion criteria

Exclusion criteria: 1. Lymphoma infiltrate the central nerves system; 2. With previous history of serious heart disease, including a clinical significance ventricular tachycardia (VT), atrial fibrillation (AF), cardiac conduction block, the onset of myocardial infarction (MI) within 1 year, congestive heart failure (CHF), and symptomatic coronary heart disease which require pharmacotherapy; 3. Patients are allergic to any ingredient in chemotherapy regimens or serious allergic constitution; 4. Patients are not suitable for this study defined by researcher.

Design outcomes

Primary

MeasureTime frame
Event-freeSurvival;

Secondary

MeasureTime frame
Overall Response Rate;Complete Remission;Overall Survival;

Countries

China

Contacts

Public ContactGang Wu

Union Hospital,Tongji Medical College,Huazhong University of Science and Technology

xhzlwg@163.com13871240042

Outcome results

None listed

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