NCT02732236

Brief Summary

Marginal zone lymphoma is a rare of subtype of Non-Hodgkin Lymphoma. Because of its rarity, prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL patients' cohort for several observation study

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

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

March 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

6.9 years

First QC Date

April 4, 2016

Last Update Submit

April 17, 2018

Conditions

Lymphoma, B-Cell, Marginal Zone

Keywords

marginal zone lymphomaCohortRituximabHBV

Outcome Measures

Primary Outcomes (1)

  • Hepatitis B virus reactivation in patients with marginal zone B-cell lymphoma after rituximab containing treatment

    Rate of HBV reactivation

    up to 12 months

Interventions

RituximabOTHER

Cohort observation study

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who is diagnosed as a marginal zone lymphoma- nodal MZL, marginal zone lymphoma of MALT type, splenic MZL

You may qualify if:

  • pathological confirmed marginal zone lymphoma
  • No history of chemotherapy
  • enable to routine staging w/u and sampling including HBV serology
  • informed consent

You may not qualify if:

  • mixed with other type lymphoma
  • refuse informed consent
  • co-existing cancer needed treatment
  • prior organ transplantation
  • accompany with immunodeficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sung Yong Oh

Busan, 602-715, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Sung Yong Oh

    Consortium for improving survival of lymphoma office

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Yong Oh, MD, PhD

CONTACT

+82-51-240-2808drosy@dau.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 8, 2016

Study Start

March 1, 2013

Primary Completion

February 1, 2020

Study Completion

February 1, 2022

Last Updated

April 18, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

We will share collected data with participated investigators in Korea

Locations

KR(1)