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

NCT ID: NCT01210287

Last Updated: 2014-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Observation

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

Group Type NO_INTERVENTION

nucleoside analog reverse transcriptase inhibitor

Intervention Type DRUG

tablets 100mg qd

Interventions

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nucleoside analog reverse transcriptase inhibitor

tablets 100mg qd

Intervention Type DRUG

Other Intervention Names

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lamivudine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Junning Cao

Vice Director of the department of Medical Oncology, Fudan University Cancer Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Junning Cao, Doctor

Role: PRINCIPAL_INVESTIGATOR

member of Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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201010HBV

Identifier Type: -

Identifier Source: org_study_id

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