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

Hebei Medical University

Status: Unknown

Conditions: Diffuse Large B-cell Lymphoma

Treatments: Drug: PL-doxorubicin and epirubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT03022123

CSPC-DMS- DLBCL -02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

pegylated liposomal doxorubicin

Experimental group

Description:

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.

Treatment:

Drug: PL-doxorubicin and epirubicin

Epirubicin

Active Comparator group

Description:

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.

Treatment:

Drug: PL-doxorubicin and epirubicin