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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00262210
First Posted: December 6, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Health Research Institutes, Taiwan
  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
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

  Eligibility

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
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
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


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

ClinicalTrials.gov Identifier: NCT00262210     History of Changes
Other Study ID Numbers: T1495
First Submitted: December 5, 2005
First Posted: December 6, 2005
Last Update Posted: December 9, 2005
Last Verified: December 2005

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Hepatitis B
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Cyclophosphamide
Etoposide
Prednisolone
Epirubicin
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