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A Randomized Study in Non-Hodgkin's Lymphoma Patients Carrying Hepatitis B Surface Antigen

This study has been completed.
Sponsor:
Collaborators:
National Taiwan University Hospital
Mackay Memorial Hospital
National Cheng-Kung University Hospital
Taipei Veterans General Hospital, Taiwan
Chi Mei Medical Hospital
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00201318
First received: September 12, 2005
Last updated: September 13, 2005
Last verified: September 2005
  Purpose

* AIMS OF THE STUDY (STUDY OBJECTIVES)

  1. To test the effect of daily lamivudine (100 mg) in reducing the risk of HBV reactivation and hepatitis development in HBsAg (+) NHL patients.
  2. To test the efficacy of daily lamivudine in preventing and treating hepatitis B reactivation and in circumventing hepatic failure and death.
  3. To test whether lamivudine can improve the overall outcome of NHL patients who are HBV carriers.

(Study end-points: The major end-point: hepatitis B reactivation in NHL patients---defined by higher than 10-fold increase of serum HBV DNA level and/or reappearance of HBeAg in the serum during and within 6 months after chemotherapy. The minor end-point I : events of hepatic failure and death---defined by jaundice with hepatic encephalopathy. The minor end-point II: the response rate and survival rate in HBsAg-positive NHL patients receiving lamivudine prophylaxis and treatment.)


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Cyclophosphamide Doxorubicin Vincristine Lamivudine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study of Lamivudine Prophylaxis or Treatment Against Hepatitis B Reactivation in Non-Hodgkin's Lymphoma Patients Carrying Hepatitis B Surface Antigen

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • We expect to enter 33 patients per year. Taking into account 10﹪dropout rate, we may finish accrual of patients within 3 years.

Estimated Enrollment: 50
Study Start Date: September 2001
Estimated Study Completion Date: October 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • Inclusion Criteria:

    1. Histologically proven NHL, and for which intensive chemotherapy is considered treatment-of-choice.
    2. HBsAg-positive.
    3. No previous chemotherapy and radiotherapy, no concurrent radiotherapy.
    4. AGC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood.
    5. Total bilirubin < 2.5 mg/dl. Alanine aminotransferase (SGPT) < 200 I.U./L
    6. Serum creatinine ≦1.5 mg/dl Blood urea nitrogen (BUN) ≦ 25 mg/dl
    7. Objectively measurable or valuable disease
    8. Signed informed consent
  • Exclusion Criteria:

    1. Age > 75 years old, or Age < 15 years old
    2. Pregnant or breast-feeding women.
    3. Patients with history of brain metastasis or CNS involvement.
    4. Child's class B or C in patients with liver cirrhosis.
    5. Impaired cardiac function with NYHA (New York Heart Association) classification ≧ Gr II.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201318

Locations
Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Mackay Memorial Hospital
National Cheng-Kung University Hospital
Taipei Veterans General Hospital, Taiwan
Chi Mei Medical Hospital
Investigators
Study Chair: Pei-Jer Chen, Ph.D. National Taiwan University Hospital
Study Chair: Ann-Lii Cheng, Ph.D. National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00201318     History of Changes
Other Study ID Numbers: T1401
Study First Received: September 12, 2005
Last Updated: September 13, 2005
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Lymphoma
Lymphoma, Non-Hodgkin
DNA Virus Infections
Digestive System Diseases
Hepadnaviridae Infections
Hepatitis, Viral, Human
Immune System Diseases
Immunoproliferative Disorders
Liver Diseases
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Virus Diseases
Cyclophosphamide
Lamivudine
Alkylating Agents
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on November 20, 2014