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Trial record 53 of 2158 for:    doxorubicin

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

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ClinicalTrials.gov Identifier: NCT03022123
Recruitment Status : Unknown
Verified October 2016 by Hebei Medical University Fourth Hospital.
Recruitment status was:  Recruiting
First Posted : January 16, 2017
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
Hebei Medical University Fourth Hospital

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.

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: PL-doxorubicin and epirubicin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Study of Pegylated Liposomal Doxorubicin Contrast Epirubicin for the Initial Treatment of Patients With Diffuse Large B-cell Lymphoma
Study Start Date : November 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : March 2018


Arm Intervention/treatment
Experimental: 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.
Drug: 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 Names:
  • prednisone
  • vincristine
  • cyclophosphamide
  • rituximab

Active Comparator: 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.
Drug: 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 Names:
  • prednisone
  • vincristine
  • cyclophosphamide
  • rituximab




Primary Outcome Measures :
  1. overall response rate [ Time Frame: up to 19 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022123


Contacts
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Contact: Liu Lihong, archiater 13831177920

Locations
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China, Hebei
Fourth Hospital of Hebei Medical University Recruiting
Shi Jiazhuang, Hebei, China, 050000
Contact: Liu Lihong, archiater    13831177920      
Sponsors and Collaborators
Hebei Medical University Fourth Hospital
Investigators
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Principal Investigator: Liu Lihong, archiater Hebei Medical University Fourth Hospital
Study Director: Liu Lihong, archiater Hebei Medical University Fourth Hospital

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Responsible Party: Hebei Medical University Fourth Hospital
ClinicalTrials.gov Identifier: NCT03022123     History of Changes
Other Study ID Numbers: CSPC-DMS- DLBCL -02
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Doxorubicin
Liposomal doxorubicin
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisone
Cyclophosphamide
Rituximab
Vincristine
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors