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A Comparative Study for Non-Hodgkin's Lymphoma in Hepatitis B Virus Carriers

This study has been completed.
Information provided by:
National Health Research Institutes, Taiwan Identifier:
First received: December 5, 2005
Last updated: NA
Last verified: December 2005
History: No changes posted


  1. To test if steroid-free chemotherapeutic regimens decrease the risk of HBV reactivation and hepatitis development in HBsAg (+) carriers.
  2. To compare the efficacy of steroid-free chemotherapeutic regimens with that of steroid-containing regimens in terms of lymphoma control.
  3. To study the change of activity of HBV and other hepatotropic viruses during the course of chemotherapy.

Condition Intervention Phase
Non-Hodgkin's Lymphoma Drug: Cyclophosphamide Epirubicin Etoposide Prednisolone Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study for Non-Hodgkin's Lymphoma in Hepatitis B Virus Carriers

Resource links provided by NLM:

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

Primary Outcome Measures:
  • We expect to enter 25 patients per year and finish accrual of patients within 4 years.

Estimated Enrollment: 50
Study Start Date: June 1995
Estimated Study Completion Date: December 1999
  Show Detailed Description


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
    4. No concurrent radiotherapy. 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 evaluable disease
    8. Signed informed consent
  • Exclusion Criteria:

    1. Age > 75 years, or Age < 15 years
    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 ≧ GrII.
    6. Concurrent glucocorticoids use (for other reasons). The conventional use of glucocorticoids for antiemetic purpose is also not allowed.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00262210

National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Principal Investigator: Ann-Lii Cheng, Ph.D. Lymphoma Disease Committee of TCOG
  More Information Identifier: NCT00262210     History of Changes
Other Study ID Numbers: T1495
Study First Received: December 5, 2005
Last Updated: December 5, 2005

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Hepatitis B
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic processed this record on August 23, 2017