Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP (IHBVRL)

Fudan University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Lymphoma

Treatments: Drug: nucleoside analog reverse transcriptase inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT01210287

201010HBV

Details and patient eligibility

About

The aim of this study is to identify the incidence of hepatitis B virus reactivation rate in Diffuse Large B Cell or high grade Follicular lymphoma patients with prior resolved hepatitis B undergoing RCHOP immuno-chemotherapy.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Naive DLBCL or high grade FL patients
• Age range 18-75 years old
• ECOG performance status 0-3
• Life expectancy of more than 3 months
• Adequate organ function
• HBsAg negative/HBcAb positive at baseline

Exclusion criteria

• Infection of HAV,HCV,HIV
• Pregnant or lactating women
• Serious uncontrolled diseases

Trial design

110 participants in 1 patient group

Observation

No Intervention group

Description:

Observation of the HBV reactivation in HBsAg negative/HBcAg positive patients receiving RCHOP without prophylactic anti-HBV treatment.

Treatment:

Drug: nucleoside analog reverse transcriptase inhibitor