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

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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 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.)

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborators: Chi Mei Medical Hospital; Mackay Memorial Hospital; National Cheng-Kung University Hospital; National Taiwan University Hospital; Taipei Veterans General Hospital, Taiwan
• Treatments: Cyclophosphamide; Doxorubicin; Lamivudine; Vincristine

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, 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.