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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-03-31

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.

Conditions

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Diffuse Large B-cell Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

PL-doxorubicin and epirubicin

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

PL-doxorubicin and epirubicin

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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prednisone vincristine cyclophosphamide rituximab

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hebei Medical University Fourth Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Liu Lihong, archiater

Role: CONTACT

13831177920

Facility Contacts

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Liu Lihong, archiater

Role: primary

13831177920

Other Identifiers

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CSPC-DMS- DLBCL -02

Identifier Type: -

Identifier Source: org_study_id

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