Brief Summary

The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Positive lymphoma patients treated with rituximab-based immunochemotherapy.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for phase_4

Timeline

Completed

Started Jan 2013

Longer than P75 for phase_4

Geographic Reach

1 country

13 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.9 years study duration

Study Start

First participant enrolled

January 1, 2013

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2013

Completed

6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2013

Completed

4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed

Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

4.9 years

First QC Date

January 9, 2013

Last Update Submit

January 8, 2017

Conditions

Hepatitis B

Keywords

LymphomaHepatitis B VirusTherapeutic UsesAntiviral Agentsrituximab

Outcome Measures

Primary Outcomes (1)

the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis
from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy

Secondary Outcomes (5)

the incidence of hepatitis B virus virological response
from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
the incidence of hepatitis B virus serological response
from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
the incidence of hepatitis B virus maintained response
from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
the incidence of hepatitis B virus sustained response
from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
the incidence of hepatitis B virus relapse and relapse related hepatitis
from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy

Study Arms (1)

Entecavir prophylaxis

EXPERIMENTAL

Participants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of immunochemotherapy and/or chemotherapy, and will be continued until 12 months after completion of the immunochemotherapy and/or chemotherapy.

Drug: Entecavir prophylaxis

Interventions

Entecavir prophylaxisDRUG

Entecavir 0.5mg daily from day 1 of immunochemotherapy and/or chemotherapy to 12 months after completing immunochemotherapy and/or chemotherapy. In patients with low load of hepatitis B virus DNA(≤2000 IU/ml), rituximab will be administrated at the beginning of entecavir prophylaxis. And in patients with high load of hepatitis B virus DNA(\>2000 IU/ml), rituximab will be administrated when hepatitis B virus DNA decreased to the level of 2000 IU/ml after entecavir prophylaxis.

Also known as: Baraclude

Entecavir prophylaxis

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

treatment-naive patients with B-cell lymphoma
HBsAg positive at baseline
treated with rituximab-based immunochemotherapy
life expectancy of more than 3 months

You may not qualify if:

younger than 18 years old
HBsAg negative at baseline
pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peking Universitylead

Study Sites (13)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

307 Hospital of the Chinese People's Liberation Army