Clinical trial · Interventional
Clinical Application of Polyethylene Glycol Liposome Doxorubicin (PLD) in Primary Lymphoma
NCT02526823CI-TRIAL-00037897unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Non-Hodgkin;Hodgkin Disease | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R-CDOP/CDOPE or DBVD chemotherapy regimen | Drug | — | UNRESOLVED |
| R-CHOP/CHOPE or ABVD chemotherapy regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- R-CHOP/CHOPE or ABVD chemotherapy regimen
- description
- R-CHOP/CHOPE every 21 days or ABVD every 28 days for total 6 courses
- interventionNames
- Drug: R-CHOP/CHOPE or ABVD chemotherapy regimen
- type
- EXPERIMENTAL
- label
- R-CDOP/CDOPE or DBVD chemotherapy regimen
- description
- R-CDOP/CDOPE every 21 days or DBVD every 28 days for total 6 courses
- interventionNames
- Drug: R-CDOP/CDOPE or DBVD chemotherapy regimen
Primary outcomes (1)
- measure
- Percentage of patients with complete remission (CR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDLotrionte M, Biondi-Zoccai G, Abbate A, Lanzetta G, D'Ascenzo F, Malavasi V, Peruzzi M, Frati G, Palazzoni G. Review and meta-analysis of incidence and clinical predictors of anthracycline cardiotoxicity. Am J Cardiol. 2013 Dec 15;112(12):1980-4. doi: 10.1016/j.amjcard.2013.08.026. Epub 2013 Sep 25. PMID 24075281
- BACKGROUNDItalian Multicentre Breast Study with Epirubicin; Ambrosini G, Balli M, Garusi G, Demicheli R, Jirillo A, Bonciarelli G, Bruscagnin G, Fila G, Bumma C, Lacroix F, Buzzi F, Di Costanzo F, Padalino D, Brugia M, Calabresi F, Natali M, Cartei G, Chiesa G, Blasina B, Ciambellotti E, Moro G, D'Aquino S, Altavilla G, Adamo V, De Maria D, Falchi AM, Bertoncelli P, Farris A, Fiorentino M, Fornasiero A, Fosser V, Daniele O, Foggi CM, Speranza GB, Sartori S, Camilluzzi E, Gallo L, Poggio R, Secondo V, Gambi A, Grignani F, Capodicasa E, Lopez M, Papaldo P, Di Lauro L, Vici P, Marenco G, Folco U, Bonanni F, Marsilio P, Palazzotto G, Di Carlo A, Cusimano MP, Pastorino G, Puccetti C, Giusto M, Rausa L, Gebbia N, Palmeri S, D'Alessandro N, Saccani F, Becchi G, Schieppati G, Spinelli I, Tagliagambe A, Tonato M, Minotti V, Ardia A, Viaro D, De Micheli P, Zingali G, Sacchetti G, Intini C. Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial. J Clin Oncol. 1988 Jun;6(6):976-82. doi: 10.1200/JCO.1988.6.6.976. PMID 2897433
- BACKGROUNDBai B, Huang HQ, Cai QQ, Wang XX, Cai QC, Lin ZX, Gao Y, Xia Y, Bu Q, Guo Y. Promising long-term outcome of gemcitabine, vinorelbine, liposomal doxorubicin (GVD) in 14-day schedule as salvage regimen for patients with previously heavily treated Hodgkin's lymphoma and aggressive non-Hodgkin's lymphoma. Med Oncol. 2013 Mar;30(1):350. doi: 10.1007/s12032-012-0350-5. Epub 2013 Jan 18. PMID 23329307
- BACKGROUNDClozel T, Deau B, Benet C, Franchi P, Robin M, Madelaine I, Thieblemont C, de Kerviler E, Briere J, Brice P. Pegylated liposomal doxorubicin: an efficient treatment in patients with Hodgkin lymphoma relapsing after high dose therapy and stem cell transplation. Br J Haematol. 2013 Sep;162(6):846-8. doi: 10.1111/bjh.12428. Epub 2013 Jun 24. No abstract available.