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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-CHOP/CHOPE or ABVD chemotherapy regimen | Active Comparator | R-CHOP/CHOPE every 21 days or ABVD every 28 days for total 6 courses |
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| R-CDOP/CDOPE or DBVD chemotherapy regimen | Experimental | R-CDOP/CDOPE every 21 days or DBVD every 28 days for total 6 courses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-CHOP/CHOPE or ABVD chemotherapy regimen | Drug | R-CHOP: Rituximab:375mg/m2,ivgtt,D0; Epirubicin:70 mg/m2,ivgtt,D1 ; Cyclophosphamide:750 mg/m2,ivgtt,D1; Vincristine: 1.4 mg/m2 ivgtt,D1 ; Prednison:100mg/d,po,D1-5; CHOPE: Epirubicin:70 mg/m2,ivgtt,D1 ; Cyclophosphamide:750 mg/m2,ivgtt,D1; Vincristine: 1.4 mg/m2 ivgtt,D1 ; Prednison:100mg/d,po,D1-5; Etoposide: 100 mg/(m2•d),ivgtt,D1-3; ABVD: Epirubicin:35 mg/m2,ivgtt,D1、15; Bleomycin:10 mg/m2,ivgtt,D1、15; Vincristine:1.4 mg/m2,ivgtt,D1、15; Dacarbazine:375mg/m2,ivgtt,D1、15; |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Provincial Hospital Affiliated to Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24075281 | Background | Lotrionte 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. | |
| 2897433 | Background |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| R-CDOP/CDOPE or DBVD chemotherapy regimen | Drug | R-CDOP: Rituximab:375mg/m2,ivgtt,D0; PLD 30-40 mg/m2,ivgtt,D1 ; Cyclophosphamide:750 mg/m2,ivgtt,D1; Vincristine: 1.4 mg/m2 ivgtt,D1 ; Prednison:100mg/d,po,D1-5; CDOPE: PLD 30-40 mg/m2,ivgtt,D1; Cyclophosphamide:750 mg/m2,ivgtt,D1; Vincristine: 1.4 mg/m2 ivgtt,D1 ; Prednison:100mg/d,po,D1-5; Etoposide: 100 mg/(m2•d),ivgtt,D1-3; DBVD: PLD 15-20 mg/m2,ivgtt,D1; Bleomycin:10 mg/m2,ivgtt,D1、15; Vincristine:1.4 mg/m2,ivgtt,D1、15; Dacarbazine:375mg/m2,ivgtt,D1、15; |
|
| Italian 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. |
| 23329307 | Background | Bai 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. |
| 23789905 | Background | Clozel 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. |
| 21850390 | Background | Schmitt CJ, Dietrich S, Ho AD, Witzens-Harig M. Replacement of conventional doxorubicin by pegylated liposomal doxorubicin is a safe and effective alternative in the treatment of non-Hodgkin's lymphoma patients with cardiac risk factors. Ann Hematol. 2012 Mar;91(3):391-7. doi: 10.1007/s00277-011-1308-y. Epub 2011 Aug 18. |
| 21372831 | Background | Fan Y, Lin NM, Luo LH, Fang L, Huang ZY, Yu HF, Wu FQ. Pharmacodynamic and pharmacokinetic study of pegylated liposomal doxorubicin combination (CCOP) chemotherapy in patients with peripheral T-cell lymphomas. Acta Pharmacol Sin. 2011 Mar;32(3):408-14. doi: 10.1038/aps.2010.217. |
| 23210520 | Background | Rafiyath SM, Rasul M, Lee B, Wei G, Lamba G, Liu D. Comparison of safety and toxicity of liposomal doxorubicin vs. conventional anthracyclines: a meta-analysis. Exp Hematol Oncol. 2012 Apr 23;1(1):10. doi: 10.1186/2162-3619-1-10. |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |