Intercontinental Cooperative Non-Hodgkin T-cell Lymphoma Prospective Registry Study

September 8, 2020 updated by: Won Seog Kim, Samsung Medical Center
The better understanding of non-Hodgkin T-cell lymphoma is essential for establishing effective treatment strategy for non-Hodgkin T-cell lymphoma. Therefore, the data about conical features and treatment outcomes of each subtype should be accumulated to establish treatment strategy. However, the majority of previous data for non-Hodgkin T-cell lymphoma was from small case series of single institute. Furthermore, as novel drugs were developed for the treatment of relapsed or refractory T-cell lymphoma, the date from patients who were treated with those novel drugs are especially required because their outcomes may reflect the outcomes of currently available treatments. Thus, a multinational, multicenter prospective registry study is needed to provide information useful for establishing treatment strategies for T-cell lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

T-cell non-Hodgkin lymphoma

Description

Inclusion Criteria:

  • Pathologically diagnosed Mature T-cell non-Hodgkin lymphoma based on the World Health Organization classification 2008
  • Newly diagnosed patients without a previous treatment history for T-cell lymphoma or relapsed/refractory T-cell lymphoma patients
  • Age ≥19 years
  • Written informed consent

Exclusion Criteria:

  • Hodgkin lymphoma
  • non-Hodgkin B-cell lymphoma
  • Immature non-Hodgkin T-cell lymphoma: Precursor T-lymphoblastic lymphoma/leukemia
  • Not understanding informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
non-Hodgkin T-cell Lymphoma
Other: Prospective Registry

Survival and disease status follow-up at 1st primary treatment, 1st salvage treatment and 2nd salvage treatment

  1. Regimen
  2. Response Evaluation
  3. SUSAR(Suspected, Unexpected, Serious, Adverse Reaction) collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 5 years
5 years
Overall response rate to primary treatment and salvage treatment
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

February 21, 2016

First Posted (Estimate)

February 25, 2016

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-11-070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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