Procarbazine Hydrochloride Capsule (Natulan®) Clinical Trial Protocol

NCT02800447 | Unknown

• 1 other identifier: Zhaoke-NTL-2015-01
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To observe and compare the overall response rate (ORR) of baseline BEACOPP and ABVD regimens for patients with advanced Hodgkin's lymphoma.
2. 2.To evaluate the safety of Natulan® in Chinese patients with advanced Hodgkin's lymphoma

Conditions

Advanced Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• safety as measured by changes of vital signs, ECG and AE number

  45 months

Study Arms (2)

Treatment

EXPERIMENTAL

baseline BEACOPP regimen

Drug: Natulan

controlled group

ACTIVE COMPARATOR

ABVD regimen

Drug: ABVD

Interventions

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

Also known as: Procarbazine hydrochloride capsules

Treatment

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;

controlled group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

MeSH Terms

Interventions

Procarbazine

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 15, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 4, 2018

Record last verified: 2018-08