Procarbazine Hydrochloride Capsule (Natulan®) Clinical Trial Protocol
- Registration Number
- NCT02800447
- Lead Sponsor
- Lee's Pharmaceutical Limited
- Brief Summary
1. To observe and compare the overall response rate (ORR) of baseline BEACOPP and ABVD regimens for patients with advanced Hodgkin's lymphoma.
2. To evaluate the safety of Natulan® in Chinese patients with advanced Hodgkin's lymphoma
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 92
- The subject is of age 18~65, both male and female;
- Newly pathologically diagnosed with classical Hodgkin's lymphoma (lymphocyte depletion type, lymphocyte rich type, nodular sclerosing type, and mixed cellularity type), who had not accepted previous treatment;
- Had stage IIB, III or IV disease, as assessed by the Ann Arbor classification;
- ECOG≤2, life expectancy ≥3 month;
- A negative serum pregnancy test required for sexually active women of childbearing potential;
- The subject voluntarily gives written informed consent to participate in the study.
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Hematopoietic function:
- Leukocyte <3,500/mm3（3.5×109/L）
- Neutrophils <1,500/mm3（1.5×109/L）
- Platelets <100,000/mm3（100×109/L）
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Intolerance to any of the active ingredients and/or excipients in the study medications;
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Severe central nervous system disorders and mental illness;
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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%);
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History of severe lung disease;
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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);
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Uncontrolled, systemic, active infection；
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Positive serology to HIV;
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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);
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Other previous or concomitant malignancy, except for basal cell carcinoma and/or cervical carcinoma in situ;
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The subject is receiving an investigational drug, or has participated in an investigational study within 30 days prior to screening;
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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;
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Investigators believe subjects not suitable to participate in the study for other reasons.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description controlled group ABVD ABVD regimen Treatment Natulan baseline BEACOPP regimen
- Primary Outcome Measures
Name Time Method overall response rate (ORR) 45 months Compare the overall response rate (ORR) of baseline BEACOPP and ABVD regimens for in patients with advanced Hodgkin's lymphoma.
- Secondary Outcome Measures
Name Time Method safety as measured by changes of vital signs, ECG and AE number 45 months