NCT01809600

Brief Summary

This retrospective study is aimed at evaluating the safety and efficacy of rituximab-containing immunochemotherapy in adult patients with Burkitt's lymphoma (BL) or high-grade B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and BL.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

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
1 month until next milestone

First Submitted

Initial submission to the registry

March 8, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

March 8, 2013

Last Update Submit

February 22, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Event-free survival

    Event-free survival is measured from the time from treatment initiation to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death)

    one year

Secondary Outcomes (3)

  • complete response rate

    1-year

  • overall survival

    1-year

  • Grade 4 hematologic toxicities

    one year

Study Arms (1)

Patients with Burkitt's Lymphoma

should be diagnosed pathologically by WHO 2008 criteria

Other: No intervention (observational study)

Interventions

Patients with Burkitt's Lymphoma

Eligibility Criteria

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

patients who were treated with Burkitt's or Burkitt-like high-grade B-cell lymphoma in Republic of Korea

You may qualify if:

  • pathologically confirmed Burkitt's lymphoma (BL) or High grade B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and BL (BL-U) by WHO 2008 criteria
  • age \>20 yrs
  • received rituximab+chemotherapy as first-line treatment
  • with measurable or evaluable lesion

You may not qualify if:

  • \. patients with BL or BL-U previously treated with rituximab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

Location

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

Observation

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Suk Jin Kim, MD, PhD

    Samsung Medical Center, Seoul, Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Internal Medicine

Study Record Dates

First Submitted

March 8, 2013

First Posted

March 13, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations