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

Phase 4

• Conditions: Lymphoma, Non-Hodgkin;Hodgkin Disease
• Interventions: Drug: R-CHOP/CHOPE or ABVD chemotherapy regimen; Drug: R-CDOP/CDOPE or DBVD chemotherapy regimen

• Registration Number: NCT02526823
• Lead Sponsor: Shandong Provincial Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-15
• Study First Posted: 2015-08-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-02
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
R-CHOP/CHOPE or ABVD chemotherapy regimen	R-CHOP/CHOPE or ABVD chemotherapy regimen	R-CHOP/CHOPE every 21 days or ABVD every 28 days for total 6 courses
R-CDOP/CDOPE or DBVD chemotherapy regimen	R-CDOP/CDOPE or DBVD chemotherapy regimen	R-CDOP/CDOPE every 21 days or DBVD every 28 days for total 6 courses

Primary Outcome Measures

Name	Time	Method
Percentage of patients with complete remission （CR）	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.

Trial Locations

Locations (1)

Department of Hematology, Provincial Hospital Affiliated to Shandong University; 🇨🇳 Jinan, Shandong, China