The Study of Pegylated Liposomal Doxorubicin Contrast Epirubicin for the Treatment of Diffuse Large B-cell Lymphoma

Not Applicable

• Conditions: Diffuse Large B-cell Lymphoma
• Interventions: Drug: PL-doxorubicin and epirubicin

• Registration Number: NCT03022123
• Lead Sponsor: Hebei Medical University Fourth Hospital

Brief Summary

270 untreated patients, age between 18 and 65 years , with diffuse large B-cell lymphoma (B-DLCL) were treated with a pegylated liposomal doxorubicin (PL-doxorubicin) modified CHOP-rituximab regimen. PL-doxorubicin 35-40 mg/m(2)and epirubicin 70mg/m(2) were given in combination with standard dosage of prednisone, vincristine, cyclophosphamide, rituximab (according to CHOP-R regimen) every 21 days for six courses.

Detailed Description

PL-doxorubicin 35-40 mg/m(2) and epirubicin 70mg/m(2) were given on day 1 in combination with standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen) every 21days for six courses. The choice to adopt the dosage of 30 mg/m2(instead of 50 mg/m2 of conventionaldoxorubicin) was based on pharmacokinetic data and on the results of previous studies in lymphoma.Rituximab 375 mg/m2 was given on day 0 in subsequent courses of therapy. Granulocyte colony-stimulating factor was given in the presence of grade 4 neutropenia or febrile neutropenia until hematological recovery. Treatment was stopped if lymphoma progressed, the patient refused further participation,or if there was any other intercurrent clinical condition or adverse event.

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-11
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-13
• Last Update Submitted: 2017-01-13
• Study First Posted: 2017-01-16
• Last Update Posted: 2017-01-16
• Primary Completion: 2017-11
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 270

Inclusion Criteria

• Age between 18 and 65 years
• Diagnosis of previously-untreated DLBCL(patients with a transformed untreated low-grade lymphoproliferative disease were accepted)
• ECOG performance status < 3 (and higher if due to lym-phoma)
• No symptomatic cardiac arrythmias or heart failure
• Acceptable renal, hepatic and pulmonary function
• Standard laboratory and radiological staging procedures and left ventricular ejection fraction analysis by echocardiography or scintigraphy were required before therapy in all cases
• The protocol was approved by the ethics review committee of each partici- pating center
• All patients gave informed written consent.

Exclusion Criteria

• Patients with a previous history of cardiac disease;
• HIV-HBsAg-HCV positivity, central nervous system involvement or any other major clinicalcondition;
• Other than lymphoma, which might have precluded a regular therapeutic course, were excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pegylated liposomal doxorubicin	PL-doxorubicin and epirubicin	PL-doxorubicin 35-40 mg/m(2) was given on day 1 in combination with standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen) every 21 days for six courses;Rituximab 375 mg/m(2) was given on day 0.
Epirubicin	PL-doxorubicin and epirubicin	Epirubicin 70 mg/m(2) was given on day 1 in combination with standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen) every 21 days for six courses;Rituximab 375 mg/m(2) was given on day 0.

Primary Outcome Measures

Name	Time	Method
overall response rate	up to 19 months

Trial Locations

Locations (1)

Fourth Hospital of Hebei Medical University; 🇨🇳 Shi Jiazhuang, Hebei, China