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

Primary Purpose

Diffuse Large B-cell Lymphoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

PL-doxorubicin and epirubicin

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Fourth Hospital of Hebei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pegylated liposomal doxorubicin

Epirubicin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

overall response rate

Secondary Outcome Measures

Full Information

NCT ID

NCT03022123

First Posted

January 9, 2017

Last Updated

January 13, 2017

Sponsor

Hebei Medical University Fourth Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03022123

Brief Title

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

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

November 2017 (Anticipated)

Study Completion Date

March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hebei Medical University Fourth Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B-cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

pegylated liposomal doxorubicin

Arm Type

Experimental

Arm Description

Arm Title

Epirubicin

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

PL-doxorubicin and epirubicin

Other Intervention Name(s)

prednisone, vincristine, cyclophosphamide, rituximab

Intervention Description

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.

Primary Outcome Measure Information:

Title

overall response rate

Time Frame

up to 19 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liu Lihong, archiater

Phone

13831177920

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liu Lihong, archiater

Organizational Affiliation

Hebei Medical University Fourth Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Liu Lihong, archiater

Organizational Affiliation

Hebei Medical University Fourth Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Fourth Hospital of Hebei Medical University

City

Shi Jiazhuang

State/Province

Hebei

ZIP/Postal Code

050000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liu Lihong, archiater

Phone

13831177920

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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