Status:
COMPLETED
A Comparative Study for Non-Hodgkin's Lymphoma in Hepatitis B Virus Carriers
Lead Sponsor:
National Health Research Institutes, Taiwan
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
Brief Summary
\* 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-...
Detailed Description
\* TREATMENT PLANS FOR FIRST-LINE AND SECOND LINE CHEMOTHERAPY 1. First-line Chemotherapy 1.1 PACE and ACE Treatment Scheme of PACE and ACE\* Cyclophosphamide 650 mg/m2, i.v. Day 1 Epirubicin 60 mg/m...
Eligibility Criteria
Inclusion
- Histologically proven NHL, and for which intensive chemotherapy is considered treatment-of-choice.
- HBsAg-positive.
- No previous chemotherapy and radiotherapy.
- No concurrent radiotherapy. AGC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood.
- Total bilirubin ≦ 2.5 mg/dl. Alanine aminotransferase (SGPT) \< 200 I.U/L
- Serum creatinine ≦1.5 mg/dl Blood urea nitrogen (BUN) ≦ 25 mg/dl
- Objectively measurable or evaluable disease
- Signed informed consent
Exclusion
- Age \> 75 years, or Age \< 15 years
- Pregnant or breast-feeding women.
- Patients with history of brain metastasis or CNS involvement.
- Child's class B or C in patients with liver cirrhosis.
- Impaired cardiac function with NYHA (New York Heart Association) classification ≧ GrII.
- Concurrent glucocorticoids use (for other reasons). The conventional use of glucocorticoids for antiemetic purpose is also not allowed.
Key Trial Info
Start Date :
June 1 1995
Trial Type :
INTERVENTIONAL
End Date :
December 1 1999
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00262210
Start Date
June 1 1995
End Date
December 1 1999
Last Update
December 6 2005
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan