Clinical trial NCT03022123: The Study of Pegylated Liposomal Doxorubicin Contrast Epirubicin for the Treatment of Diffuse Large B-cell Lymphoma
Official title: The Study of Pegylated Liposomal Doxorubicin Contrast Epirubicin for the Initial Treatment of Patients With Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diffuse Large B-cell Lymphoma
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: overall response rate
timeFrame: up to 19 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shi Jiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: Hebei Medical University Fourth Hospital
name: Liu Lihong, archiater
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebei Medical University Fourth Hospital
name: Liu Lihong, archiater
role: STUDY_DIRECTOR
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