NCT01210287

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

January 8, 2014

Status Verified

January 1, 2014

Enrollment Period

3.8 years

First QC Date

September 27, 2010

Last Update Submit

January 7, 2014

Conditions

Lymphoma

Keywords

hepatitis B virus reactivationHBsAg negativeHBcAb positivelymphomarituximab

Outcome Measures

Primary Outcomes (1)

  • incidence of HBV reactivation

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

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

Secondary Outcomes (1)

  • the outcome of antiviral therapy in HBV-DNA abnormal patients

    from the initiation of antiviral thearpy to six months after the last cycle of RCHOP

Study Arms (1)

Observation

NO INTERVENTION

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

Drug: nucleoside analog reverse transcriptase inhibitor

Interventions

nucleoside analog reverse transcriptase inhibitorDRUG

tablets 100mg qd

Also known as: lamivudine
Observation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 86-21, China

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Lamivudine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosides

Study Officials

  • Junning Cao, Doctor

    member of Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director of the department of Medical Oncology, Fudan University Cancer Center

Study Record Dates

First Submitted

September 27, 2010

First Posted

September 28, 2010

Study Start

October 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 8, 2014

Record last verified: 2014-01

Locations

CN(2)