Diffuse Large B-cell Lymphoma
Conditions
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.
Interventions
DRUGPL-doxorubicin and epirubicin
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.
Sponsors
Hebei Medical University Fourth Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | up to 19 months |
Countries
China
Contacts
Primary ContactLiu Lihong, archiater
Outcome results
None listed