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RECRUITINGPhase 2INTERVENTIONAL

Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody)

Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody) (REHEB):a Single Arm, Open Label, Multi-center Phase II Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This phase 2 trial aims to evaluate the efficacy of entecavir prophylacxis for hepatitis B virus (HBV) reactivation that continues until 6 months after completing CD20 monoclonal antibody therapy in patients with CD20-positive B-cell lymphomas and resolved hepatitis B (negative hepatitis B surface antigen, positive hepatitis B core antibody).

Who May Be Eligible (Plain English)

Who May Qualify: - Histopathologically confirmed CD20 positive B-cell lymphoma; - Plan to receive first-line anti-lymphoma therapy containing CD20 monoclonal antibodies; - Negative HBsAg, HBV-DNA lower than the detection limit and positive anti-HBC at baseline; - Total bilirubin less than 1.5X the upper limit of normal (ULN), AST and ALT less than 2.5X ULN; - ECOG PS: 0\~2; - Estimated survival time \>3 months. Who Should NOT Join This Trial: - Positive HBsAg or HBV-DNA higher than the detection limit at baseline; - Previous chemotherapy or radiotherapy for lymphoma; - Other primary liver diseases, such as chronic hepatitis C, hepatitis D, autoimmune hepatitis, Wilson' s disease or primary biliary cirrhosis; - Pregnant or lactating women; - History of weakened immune system, including positive HIV, or other acquired congenital weakened immune system disease, or history of organ transplantation. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Histopathologically confirmed CD20 positive B-cell lymphoma; * Plan to receive first-line anti-lymphoma therapy containing CD20 monoclonal antibodies; * Negative HBsAg, HBV-DNA lower than the detection limit and positive anti-HBC at baseline; * Total bilirubin less than 1.5X the upper limit of normal (ULN), AST and ALT less than 2.5X ULN; * ECOG PS: 0\~2; * Estimated survival time \>3 months. Exclusion Criteria: * Positive HBsAg or HBV-DNA higher than the detection limit at baseline; * Previous chemotherapy or radiotherapy for lymphoma; * Other primary liver diseases, such as chronic hepatitis C, hepatitis D, autoimmune hepatitis, Wilson' s disease or primary biliary cirrhosis; * Pregnant or lactating women; * History of immunodeficiency, including positive HIV, or other acquired congenital immunodeficiency disease, or history of organ transplantation.

Treatments Being Tested

DRUG

Entecavir

All patients enrolled in the study will accept entecavir prophylaxis that initiates within 1 week before the first course of CD20 monoclonal antibody therapy, and continues until 6 months after completing CD20 monoclonal antibody therapy.

Locations (1)

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, State..., China