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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Provincial Hospital
• Treatments: Doxorubicin

Criteria

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.