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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
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.
    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

No publications provided Identifier: NCT00262210     History of Changes
Other Study ID Numbers: T1495
Study First Received: December 5, 2005
Last Updated: December 5, 2005
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type processed this record on March 03, 2015