A Randomized Study in Non-Hodgkin's Lymphoma Patients Carrying Hepatitis B Surface Antigen

\* 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 efficacy of daily lamivudine in preventing and treating hepatitis B reactivation and in circumventing hepatic failure and death. 3. To test whether lamivudine can improve the overall outcome of NHL patients who are HBV carriers. (Study end-points: The major end-point: hepatitis B reactivation in NHL patients---defined by higher than 10-fold increase of serum HBV DNA level and/or reappearance of HBeAg in the serum during and within 6 months after chemotherapy. The minor end-point I : events of hepatic failure and death---defined by jaundice with hepatic encephalopathy. The minor end-point II: the response rate and survival rate in HBsAg-positive NHL patients receiving lamivudine prophylaxis and treatment.)

Sex

All

Minimum age

20 Years

Maximum age

70 Years

* 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, no concurrent radiotherapy.
  4. 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 valuable disease
  8. Signed informed consent
* Exclusion Criteria:

  1. Age \> 75 years old, or Age \< 15 years old
  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 ≧ Gr II.