NCT04048395

Brief Summary

This retrospective study was proposed by the investigators to analyze treatment status and outcome in patients with early relapsed follicular lymphoma. In patients with follicular lymphoma who experienced disease progression within 24 months after initiation of treatment, the second-line therapy, stem cell transplantation, tumor response, progression free survival, and overall survival will be analyzed.

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 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

July 8, 2019

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

August 2, 2019

Last Update Submit

August 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival is defined as the time from the diagnosis to death or last follow-up.

    from the date of the IRB approval until 12 month

Secondary Outcomes (1)

  • Progression free survival

    from the date of the IRB approval until 12 month

Study Arms (1)

Follicular lymphoma arm

The analysis will involve patients diagnosed with follicular lymphoma who received induction chemotherapy and then experienced a worsening of disease within 24 months from the start date of the treatment.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The analysis will involve patients diagnosed with follicular lymphoma who received induction chemotherapy and then experienced a worsening of disease within 24 months from the start date of the treatment.

You may qualify if:

  • Patients histologically diagnosed with follicular lymphoma (ICD-10 C82.0 to C82.9)
  • Radiologically confirmed disease progression within 24 months from the start date of an induction chemotherapy
  • All of the following should be available for retrospective analysis.
  • Pathologic findings report
  • Medical records containing age, sex, date of diagnosis, clinical symptoms, laboratory findings, treatment methods, progression, survival, death, etc.

You may not qualify if:

  • Known histologic transformation to aggressive lymphoma
  • Follicular lymphoma grade 3B
  • Patients whose pathologic findings report and appropriate medical records are not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

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

Study Officials

  • Wonseog Kim, Professor

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 7, 2019

Study Start

July 8, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations