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

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ClinicalTrials.gov Identifier: NCT00262210
Recruitment Status : Completed
First Posted : December 6, 2005
Last Update Posted : December 6, 2005
Information provided by:
National Health Research Institutes, Taiwan

Brief Summary:


  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 or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Cyclophosphamide Epirubicin Etoposide Prednisolone Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : June 1995
Estimated Study Completion Date : December 1999

Resource links provided by the National Library of Medicine

Drug Information available for: Epirubicin
U.S. FDA Resources

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

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00262210     History of Changes
Other Study ID Numbers: T1495
First Posted: December 6, 2005    Key Record Dates
Last Update Posted: December 6, 2005
Last Verified: December 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