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Clinical Application of Polyethylene Glycol Liposome Doxorubicin (PLD) in Primary Lymphoma

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ClinicalTrials.gov Identifier: NCT02526823
Recruitment Status : Recruiting
First Posted : August 18, 2015
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Wang Xin, Shandong Provincial Hospital

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.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin;Hodgkin Disease Drug: R-CHOP/CHOPE or ABVD chemotherapy regimen Drug: R-CDOP/CDOPE or DBVD chemotherapy regimen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Application of Polyethylene Glycol Liposome Doxorubicin (PLD) in Primary Lymphoma
Actual Study Start Date : August 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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
Drug: R-CHOP/CHOPE or ABVD chemotherapy regimen

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
Drug: R-CDOP/CDOPE or DBVD chemotherapy regimen

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 Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526823


Locations
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China, Shandong
Department of Hematology, Provincial Hospital Affiliated to Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Xin Wang, MD, PHD    +86-531-68778331    xinw007@126.com   
Contact: Lili Feng, MD    +86-531-68776358    fenglili1982624@163.com   
Sponsors and Collaborators
Shandong Provincial Hospital
Publications:
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.

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Responsible Party: Wang Xin, Director of Department of Hematology, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT02526823    
Other Study ID Numbers: ShandongPH01
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases