Clinical trial NCT02800447: Procarbazine Hydrochloride Capsule (Natulan®) Clinical Trial Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Hodgkin's Lymphoma
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2016-06-15
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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）
* 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.

Primary outcomes:
measure: overall response rate (ORR)
timeFrame: 45 months
Secondary outcomes:
measure: safety as measured by changes of vital signs, ECG and AE number
timeFrame: 45 months
Other outcomes:
Locations:
Study officials:
References: