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

This study has been completed.
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:
First received: September 12, 2005
Last updated: September 13, 2005
Last verified: September 2005


  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


Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
  • 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00201318

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
Study Chair: Pei-Jer Chen, Ph.D. National Taiwan University Hospital
Study Chair: Ann-Lii Cheng, Ph.D. National Taiwan University Hospital
  More Information

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 B
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 by Histologic Type
Virus Diseases
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on May 30, 2016