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

• Status: Completed
• Trial end date: 1999-12-01
• Target enrollment: 0
• Participant gender: All

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-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.

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

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Treatments: Cyclophosphamide; Epirubicin; Etoposide; Prednisolone

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.