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Incidence of HBV Reactivation in HBsAg Negative/HBcAb Positive Diffuse Large B Cell Lymphoma or High Grade Follicular Lymphoma Patients: A Prospective Study


Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Lymphoma

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Trial Information

Incidence of HBV Reactivation in HBsAg Negative/HBcAb Positive Diffuse Large B Cell Lymphoma or High Grade Follicular Lymphoma Patients: A Prospective Study


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

incidence of HBV reactivation

Outcome Description:

HBV reactivation is defined as- the level of HBV-DNA exceeds the upper limit of normal(ULN).

Outcome Time Frame:

from the first cycle of RCHOP (day 1) to six months after the last cycle of RCHOP

Safety Issue:

Yes

Principal Investigator

Junning Cao, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

member of Fudan University

Authority:

China: Ethics Committee

Study ID:

201010HBV

NCT ID:

NCT01210287

Start Date:

October 2010

Completion Date:

December 2013

Related Keywords:

  • Lymphoma
  • hepatitis B virus reactivation
  • HBsAg negative
  • HBcAb positive
  • lymphoma
  • rituximab
  • Hepatitis
  • Hepatitis B
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse

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