Status:
COMPLETED
A Randomized Study in Non-Hodgkin's Lymphoma Patients Carrying Hepatitis B Surface Antigen
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
National Taiwan University Hospital
Mackay Memorial Hospital
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
Brief Summary
\* AIMS OF THE STUDY (STUDY OBJECTIVES) 1. To test the effect of daily lamivudine (100 mg) in reducing the risk of HBV reactivation and hepatitis development in HBsAg (+) NHL patients. 2. To test the...
Detailed Description
* TREATMENT PLANS 1. Systemic chemotherapy with CHOP regimen Schedule and Dose for CHOP Cyclophosphamide 750 mg/m2 i.v. Day 1 Doxorubicin 50 mg/m2 i.v. Day 1 Vincristine 1.4 mg/m2/d i.v. Day 1 Pred...
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 valuable disease
- Signed informed consent
Exclusion
- Age \> 75 years old, or Age \< 15 years old
- 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 ≧ Gr II.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00201318
Start Date
September 1 2001
End Date
October 1 2005
Last Update
September 20 2005
Active Locations (1)
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1
Mackay Memorial Hospital
Taipei, Taiwan