Clinical Application of Polyethylene Glycol Liposome Doxorubicin (PLD) in Primary Lymphoma

April 1, 2019 updated by: Wang Xin, Shandong Provincial Hospital
Anthracyclines were basic drugs in lymphoma treatment. However, their dose accumulation related cardiac toxicity limits their clinical application, especially adriamycin. Adriamycin has been gradually replaced by epirubicin. Polyethylene glycol liposome doxorubicin (PLD) can go into tumor tissues through tumor angiogenesis and produces targeted killing effect to tumor tissues. PLD has potential advantages in the treatment of malignant tumors,including lymphoma.

Study Overview

Detailed Description

Lymphoma is one of the most rapidly growing malignant tumors in the world. It was divided into two major categories (Hodgkin's lymphoma (HL) and non Hodgkin's lymphoma (NHL). Anthracyclines were basic drugs in lymphoma treatment. However, their dose accumulation related cardiac toxicity limits their clinical application, especially adriamycin. Adriamycin has been gradually replaced by epirubicin in malignant tumor treatment because of its similar effects and less toxic side effects. Polyethylene glycol liposome doxorubicin (PLD) is the liposome formulation of doxorubicin. Methoxy Polyethylene Glycol (MPEG) contained in liposome surface can decrease the peak plasma levels of free drugs, extend drugs circulation time in blood and reduce the chance of non-specific distribution to normal tissues. PLD goes into tumor tissues through tumor angiogenesis and produces targeted killing effect to tumor tissues. PLD has potential advantages in the treatment of malignant tumors. In lymphoma patients' therapy, the clinical application of PLD is expected to be a new method. Therefore, the investigators designed the randomized controlled clinical study and aimed to compare the efficacy and safety between PLD and epirubicin in primary B-NHL, peripheral T-cell lymphoma (PTCL) and HL patients.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Department of Hematology, Provincial Hospital Affiliated to Shandong University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Primary B-NHL, PTCL (ALK+ anaplastic large cell lymphoma and NK(natural killer cell )/T cell lymphoma were excluded) or HL patients confirmed by histopathology;
  2. Ages ≥18 years old, < 80 years old;
  3. ECOG (Eastern Cooperative Oncology Group)score: 0-2
  4. At least one measurable lesion;
  5. Expected survival time≥3 months;
  6. Liver function: transaminase≤2.5× upper limit of normal value,bilirubin≤1.5×upper limit of normal value;
  7. Renal function: serum creatinine is 44-133 mmol/L;
  8. Routine blood test:WBC≥3.0×109/L,Neutrophils≥1.5×109/L,Hb≥100g/L,Platelet≥80×109/L; LVEF≥50%;
  9. New York Heart Association (NYHA) heart function classification is I-II grade
  10. signed informed consent.

Exclusion Criteria:

  1. Patients with severe complications or severe infection;
  2. Invasion of central nervous system;
  3. Patients with severe heart disease history, including ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), coronary heart disease patients needed therapy;
  4. patients with severe allergic constitution, or those who are allergic to or intolerant of drug composition in chemotherapy regimens; with other malignant tumors in the past 5 years;
  5. patients received doxorubicin therapy, total cumulative dose of adriamycin was more than 300 mg/m2, total cumulative dose of epirubicin was more than 450 mg/m2;
  6. Patients participate in other clinical studies;
  7. Other patients who are not suitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: R-CHOP/CHOPE or ABVD chemotherapy regimen
R-CHOP/CHOPE every 21 days or ABVD every 28 days for total 6 courses

R-CHOP:

Rituximab:375mg/m2,ivgtt,D0; Epirubicin:70 mg/m2,ivgtt,D1 ; Cyclophosphamide:750 mg/m2,ivgtt,D1; Vincristine: 1.4 mg/m2 ivgtt,D1 ; Prednison:100mg/d,po,D1-5;

CHOPE:

Epirubicin:70 mg/m2,ivgtt,D1 ; Cyclophosphamide:750 mg/m2,ivgtt,D1; Vincristine: 1.4 mg/m2 ivgtt,D1 ; Prednison:100mg/d,po,D1-5; Etoposide: 100 mg/(m2•d),ivgtt,D1-3;

ABVD:

Epirubicin:35 mg/m2,ivgtt,D1、15; Bleomycin:10 mg/m2,ivgtt,D1、15; Vincristine:1.4 mg/m2,ivgtt,D1、15; Dacarbazine:375mg/m2,ivgtt,D1、15;

Experimental: R-CDOP/CDOPE or DBVD chemotherapy regimen
R-CDOP/CDOPE every 21 days or DBVD every 28 days for total 6 courses

R-CDOP:

Rituximab:375mg/m2,ivgtt,D0; PLD 30-40 mg/m2,ivgtt,D1 ; Cyclophosphamide:750 mg/m2,ivgtt,D1; Vincristine: 1.4 mg/m2 ivgtt,D1 ; Prednison:100mg/d,po,D1-5;

CDOPE:

PLD 30-40 mg/m2,ivgtt,D1; Cyclophosphamide:750 mg/m2,ivgtt,D1; Vincristine: 1.4 mg/m2 ivgtt,D1 ; Prednison:100mg/d,po,D1-5; Etoposide: 100 mg/(m2•d),ivgtt,D1-3;

DBVD:

PLD 15-20 mg/m2,ivgtt,D1; Bleomycin:10 mg/m2,ivgtt,D1、15; Vincristine:1.4 mg/m2,ivgtt,D1、15; Dacarbazine:375mg/m2,ivgtt,D1、15;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with complete remission (CR)
Time Frame: After two 21-day or 28-day courses, up to 42 to 56 days.
Sum of products of greatest diameters (SPD)was used to evaluate the therapy effect.Number of participants with CR was assessed by Cheson Standard.
After two 21-day or 28-day courses, up to 42 to 56 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

August 15, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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