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

Shandong First Medical University

Status and phase

Unknown

Phase 4

Conditions

Lymphoma, Non-Hodgkin;Hodgkin Disease

Treatments

Drug: R-CHOP/CHOPE or ABVD chemotherapy regimen

Drug: R-CDOP/CDOPE or DBVD chemotherapy regimen

Study type

Interventional

Funder types

Other

Identifiers

NCT02526823

ShandongPH01

Details and patient eligibility

About

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.

Full 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.

Enrollment

360 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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;
Ages ≥18 years old, < 80 years old;
ECOG (Eastern Cooperative Oncology Group）score: 0-2
At least one measurable lesion;
Expected survival time≥3 months;
Liver function: transaminase≤2.5× upper limit of normal value，bilirubin≤1.5×upper limit of normal value;
Renal function: serum creatinine is 44-133 mmol/L;
Routine blood test：WBC≥3.0×109/L，Neutrophils≥1.5×109/L，Hb≥100g/L，Platelet≥80×109/L； LVEF≥50%;
New York Heart Association (NYHA) heart function classification is I-II grade
signed informed consent.

Exclusion criteria

Patients with severe complications or severe infection;
Invasion of central nervous system;
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;
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;
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;
Patients participate in other clinical studies;
Other patients who are not suitable for the study.