- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02526823
Clinical Application of Polyethylene Glycol Liposome Doxorubicin (PLD) in Primary Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Recruiting
- Department of Hematology, Provincial Hospital Affiliated to Shandong University
-
Contact:
- Xin Wang, MD, PHD
- Phone Number: +86-531-68778331
- Email: xinw007@126.com
-
Contact:
- Lili Feng, MD
- Phone Number: +86-531-68776358
- Email: fenglili1982624@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: R-CHOP/CHOPE or ABVD chemotherapy regimen
R-CHOP/CHOPE every 21 days or ABVD every 28 days for total 6 courses
|
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; |
Experimental: R-CDOP/CDOPE or DBVD chemotherapy regimen
R-CDOP/CDOPE every 21 days or DBVD every 28 days for total 6 courses
|
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; |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients with complete remission (CR)
Time Frame: After two 21-day or 28-day courses, up to 42 to 56 days.
|
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.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ShandongPH01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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