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This is a confirmatory open-label, randomized, controlled, multicenter study. Recruited subjects are to be randomized to treatment group and controlled group, with ratio of 1:1. Treatment group will accept baseline BEACOPP regimen, while controlled group will accept ABVD regimen.
The study design consisted of a screening phase of 1 week, a treatment phase of 24 or 32 weeks, and a post treatment follow-up of at least 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | baseline BEACOPP regimen |
|
| controlled group | Active Comparator | ABVD regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natulan | Drug | Each baseline BEACOPP regimen lasts 21 days, and each cycle consists of: Cyclophosphamide injection: 650mg/m2, IV infusion, day 1; Doxorubicin hydrochloride injection: 25mg/m2, IV infusion, day 1; Etoposide injection: 100mg/m2, IV infusion, day 1~3; Natulan (procarbazine hydrochloride capsule): 100mg/m2,po, day 1~7; Bleomycin hydrochloride injection: 10mg/m2, IV or IM, day 8; Vincristine: 1.4mg/m2 (single maximum dose is 2mg), IV infusion, day 8; Prednisone tablet: 40mg/m2, po, day 1~14 |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate (ORR) | Compare the overall response rate (ORR) of baseline BEACOPP and ABVD regimens for in patients with advanced Hodgkin's lymphoma. | 45 months |
| Measure | Description | Time Frame |
|---|---|---|
| safety as measured by changes of vital signs, ECG and AE number | 45 months |
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Inclusion Criteria:
Exclusion Criteria:
Hematopoietic function:
Intolerance to any of the active ingredients and/or excipients in the study medications;
Severe central nervous system disorders and mental illness;
Severe heart disease (congestive heart failure, uncontrolled hypertension, unstable coronary artery disease, or myocardial infarction, or severe arrhythmia). Echocardiography showed resting left ventricular ejection fraction (LVEF) < 50%);
History of severe lung disease;
AST or ALT>2.5×ULN,total bilirubin≥1.5×ULN,serum creatinine>1.5×ULN (for subject with liver metastases: AST or ALT>5xULN, total bilirubin ≥ 3xULN);
Uncontrolled, systemic, active infection;
Positive serology to HIV;
HBsAg positive subjects can still be enrolled in the study, but researchers should follow "The consensus on the Treatment of Lymphoma with Hepatitis B Infections" to observe closely and/or provide prophylactic anti-HBV therapy (as per investigator's decision);
Other previous or concomitant malignancy, except for basal cell carcinoma and/or cervical carcinoma in situ;
The subject is receiving an investigational drug, or has participated in an investigational study within 30 days prior to screening;
The subject is pregnant or lactating; or subjects of childbearing potential (both women and man subjects) do not want to take effective contraceptive measures during study period or within 3 months after study completes;
Investigators believe subjects not suitable to participate in the study for other reasons.
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| ID | Term |
|---|---|
| D011344 | Procarbazine |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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|
|
| ABVD | Drug | Each ABVD cycle lasts 28 days1 cycle of the ABVD regimen consists of: Doxorubicin hydrochloride injection:25mg/m2,IV infusion,day 1 and 15; Dacarbazine injection:375mg/m2,IV infusion,day 1 and 15; Bleomycin injection:10mg/m2,IV or IM,day 1 and 15; Vincristine injection:1.4mg/m2 (single maximum dose is 2mg), IV infusion,day 1 and 15; |
|
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |