Back to resultsClinical Application of Polyethylene Glycol Liposome Doxorubicin (PLD) in Primary Lymphoma
Primary Purpose
Lymphoma, Non-Hodgkin;Hodgkin Disease
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
R-CHOP/CHOPE or ABVD chemotherapy regimen
R-CDOP/CDOPE or DBVD chemotherapy regimen
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin;Hodgkin Disease
Eligibility Criteria
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.
Sites / Locations
- Department of Hematology, Provincial Hospital Affiliated to Shandong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
R-CHOP/CHOPE or ABVD chemotherapy regimen
R-CDOP/CDOPE or DBVD chemotherapy regimen
Arm Description
R-CHOP/CHOPE every 21 days or ABVD every 28 days for total 6 courses
R-CDOP/CDOPE every 21 days or DBVD every 28 days for total 6 courses
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02526823
First Posted
August 11, 2015
Last Updated
April 1, 2019
Sponsor
Shandong Provincial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02526823
Brief Title
Clinical Application of Polyethylene Glycol Liposome Doxorubicin (PLD) in Primary Lymphoma
Official Title
Clinical Application of Polyethylene Glycol Liposome Doxorubicin (PLD) in Primary Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Provincial Hospital
4. Oversight
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin;Hodgkin Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
R-CHOP/CHOPE or ABVD chemotherapy regimen
Arm Type
Active Comparator
Arm Description
R-CHOP/CHOPE every 21 days or ABVD every 28 days for total 6 courses
Arm Title
R-CDOP/CDOPE or DBVD chemotherapy regimen
Arm Type
Experimental
Arm Description
R-CDOP/CDOPE every 21 days or DBVD every 28 days for total 6 courses
Intervention Type
Drug
Intervention Name(s)
R-CHOP/CHOPE or ABVD chemotherapy regimen
Intervention Description
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；
Intervention Type
Drug
Intervention Name(s)
R-CDOP/CDOPE or DBVD chemotherapy regimen
Intervention Description
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；
Primary Outcome Measure Information:
Title
Percentage of patients with complete remission （CR）
Description
Sum of products of greatest diameters （SPD）was used to evaluate the therapy effect.Number of participants with CR was assessed by Cheson Standard.
Time Frame
After two 21-day or 28-day courses, up to 42 to 56 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Hematology, Provincial Hospital Affiliated to Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang, MD, PHD
Phone
+86-531-68778331
Email
xinw007@126.com
First Name & Middle Initial & Last Name & Degree
Lili Feng, MD
Phone
+86-531-68776358
Email
fenglili1982624@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
24075281
Citation
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.
Results Reference
background
PubMed Identifier
2897433
Citation
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.
Results Reference
background
PubMed Identifier
23329307
Citation
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.
Results Reference
background
PubMed Identifier
23789905
Citation
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.
Results Reference
background
PubMed Identifier
21850390
Citation
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.
Results Reference
background
PubMed Identifier
21372831
Citation
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.
Results Reference
background
PubMed Identifier
23210520
Citation
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.
Results Reference
background
Learn more about this trial
Clinical Application of Polyethylene Glycol Liposome Doxorubicin (PLD) in Primary Lymphoma
We'll reach out to this number within 24 hrs