An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy With Tenofovir in HBsAg-positive Patients With Diffuse Large B-cell Lymphoma Receiving Rituximab-CHOP Chemotherapy (SPEED Study)

Yonsei University

Status: Unknown

Conditions: B-cell Lymphoma

Study type: Observational

Funder types: Other

Identifiers

NCT02354846

4-2014-0928

Details and patient eligibility

About

An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy with Tenofovir in HBsAg-positive Patients with Diffuse Large B-cell Lymphoma Receiving Rituximab-CHOP Chemotherapy (SPEED study)

Enrollment: 112 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females aged more than18
• HBsAg-positive DLBCL patients (it is possible to enrol the patients with combined DLBCL and low grade lymphoma such as follicular lymphoma)
• Previously untreated DLBCL patients who are suitable for receiving R-CHOP chemotherapy
• Serum ALT no more than 2 x ULN (including normal ALT)
• Life expectancy 6 months
• A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are no more than 1 years after the onset of menopause.
• Informed consent

Exclusion criteria

• Other subtype of lymphoma except DLBCL
• DLBCL patients who are NOT suitable for receiving R-CHOP chemotherapy OR plan to receive other chemotherapy
• patients had been treated with antiviral therapy known to have activity against HBV (e.g., alpha-interferon, lamivudine, telbivudine, clevudine, adefovir, entecavir or tenofovir) within the previous 6 months.
• evidence of hepatocellular carcinoma.
• evidence of decompensated liver disease