NCT01914744

Brief Summary

The aim of this study is to prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on CHOP/R-CHOP.

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
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 2, 2013

Status Verified

July 1, 2013

Enrollment Period

2.8 years

First QC Date

March 2, 2013

Last Update Submit

July 31, 2013

Conditions

Non-Hodgkin LymphomaHepatitis B Reactivation

Keywords

NHLHBVentecavirlamivudine

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of HBV reactivation

    Defined by increased level of HBV DNA

    12 months

Secondary Outcomes (3)

  • Incidence rate of hepatitis and HBV reactivation-related hepatitis

    6 months

  • Incidence rate and median time of treatment delay due to hepatitis

    6 months

  • Incidence rate and median time of HBV DNA level normalization

    6 months

Other Outcomes (1)

  • Incidence of drug resistance of viral variants

    3 years

Study Arms (2)

entecavir

EXPERIMENTAL

entecavir 0.5 mg/day PO

Drug: EntecavirDrug: Lamivudine

lamivudine

ACTIVE COMPARATOR

lamivudine 100 mg/day PO

Drug: EntecavirDrug: Lamivudine

Interventions

EntecavirDRUG

entecavir 0.5 mg/day PO

Also known as: baraclude
entecavirlamivudine
LamivudineDRUG

lamivudine 100 mg/day PO

Also known as: epivir
entecavirlamivudine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously untreated NHL suitable for CHOP/R-CHOP treatment
  • Age range 18-80 years old
  • HBsAg positive with high level of HBV DNA
  • Eastern Cooperative Oncology Group performance status 0-2
  • Life expectancy of more than 3 months
  • Adequate organ function

You may not qualify if:

  • Primary or secondary central nervous system involvement
  • With hepatitis C virus infection
  • Previous serious cardiac disease
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Pregnant or lactating women
  • Serious uncontrolled diseases and intercurrent infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

entecavirLamivudine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms 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

  • Ye Guo, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ye Guo, MD

CONTACT

+86 21 64175590pattrick_guo@msn.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 2, 2013

First Posted

August 2, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

August 2, 2013

Record last verified: 2013-07

Locations

CN(1)