Clincosm LogoSign in Get a demo

Procarbazine Hydrochloride Capsule (Natulan®) Clinical Trial Protocol

Sponsor
Lee's Pharmaceutical Limited (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02800447
Collaborator
(none)
92
Enrollment
2
Arms
30
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Actual Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

baseline BEACOPP regimen

Drug: Natulan
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
Other Names:
  • Procarbazine hydrochloride capsules

    		•
    Active Comparator: controlled group

    ABVD regimen

    Drug: ABVD
    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;

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. safety as measured by changes of vital signs, ECG and AE number [45 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Lee's Pharmaceutical Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lee's Pharmaceutical Limited
    ClinicalTrials.gov Identifier:
    NCT02800447
    Other Study ID Numbers:
    • Zhaoke-NTL-2015-01
    First Posted:
    Jun 15, 2016
    Last Update Posted:
    Sep 4, 2018
    Last Verified:
    Aug 1, 2018
    Additional relevant MeSH terms:
    Procarbazine

    Study Results

    No Results Posted as of Sep 4, 2018