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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Study of Pegylated Liposomal Doxorubicin Contrast Epirubicin for the Initial Treatment of Patients With Diffuse Large B-cell Lymphoma

Conditions
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Diffuse Large B-cell Lymphoma

Intervention / Treatment
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* Drug: PL-doxorubicin and epirubicin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pegylated liposomal doxorubicin<br>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. | Drug: PL-doxorubicin and epirubicin<br>* PL-doxorubicin 35-40 mg/m(2) and epirubicin 70 mg/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.<br>* Other names: rituximab;|
| Active Comparator: Epirubicin<br>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. | Drug: PL-doxorubicin and epirubicin<br>* PL-doxorubicin 35-40 mg/m(2) and epirubicin 70 mg/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.<br>* Other names: rituximab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | up to 19 months |