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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lymphoma, Non-Hodgkin;Hodgkin Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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R-CHOP/CHOPE or ABVD chemotherapy regimen

R-CHOP/CHOPE every 21 days or ABVD every 28 days for total 6 courses

Group Type ACTIVE_COMPARATOR

R-CHOP/CHOPE or ABVD chemotherapy regimen

Intervention Type 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；

R-CDOP/CDOPE or DBVD chemotherapy regimen

R-CDOP/CDOPE every 21 days or DBVD every 28 days for total 6 courses

Group Type EXPERIMENTAL

R-CDOP/CDOPE or DBVD chemotherapy regimen

Intervention Type 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；

Interventions

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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；

Intervention Type 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；

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No