The Study of Pegylated Liposomal Doxorubicin Contrast Epirubicin for the Treatment of Diffuse Large B-cell Lymphoma
NCT ID: NCT03022123
Last Updated: 2017-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
270 participants
INTERVENTIONAL
2016-11-30
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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pegylated liposomal doxorubicin
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.
PL-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.
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.
PL-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.
Interventions
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PL-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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
FEMALE
No
Sponsors
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Hebei Medical University Fourth Hospital
OTHER
Responsible Party
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Principal Investigators
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Liu Lihong, archiater
Role: PRINCIPAL_INVESTIGATOR
Hebei Medical University Fourth Hospital
Liu Lihong, archiater
Role: STUDY_DIRECTOR
Hebei Medical University Fourth Hospital
Locations
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Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Countries
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Central Contacts
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Liu Lihong, archiater
Role: CONTACT
Facility Contacts
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Liu Lihong, archiater
Role: primary
Other Identifiers
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CSPC-DMS- DLBCL -02
Identifier Type: -
Identifier Source: org_study_id
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