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

This study has been completed.
Sponsor:
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00262210
First received: December 5, 2005
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

* AIMS OF THE STUDY

  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:

U.S. FDA Resources

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

  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.
    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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262210

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Investigators
Principal Investigator: Ann-Lii Cheng, Ph.D. Lymphoma Disease Committee of TCOG
  More Information

No publications provided

ClinicalTrials.gov 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:
Hepatitis
Hepatitis A
Hepatitis B
Lymphoma
Lymphoma, Non-Hodgkin
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Epirubicin
Etoposide
Prednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate

ClinicalTrials.gov processed this record on June 17, 2013