Lymphoma, Non-Hodgkin;Hodgkin Disease Clinical Trial
Official title:
Clinical Application of Polyethylene Glycol Liposome Doxorubicin (PLD) in Primary Lymphoma
| Verified date | April 2019 |
| Source | Shandong Provincial Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 360 |
| Est. completion date | December 2019 |
| Est. primary completion date | December 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Department of Hematology, Provincial Hospital Affiliated to Shandong University | Jinan | Shandong |
| Lead Sponsor | Collaborator |
|---|---|
| Shandong Provincial Hospital |
China,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of patients with complete remission (CR) | 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. |