Intercontinental Cooperative Non-Hodgkin T-cell Lymphoma Prospective Registry Study
1 other identifier
observational
500
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2016
CompletedFirst Posted
Study publicly available on registry
February 25, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedSeptember 9, 2020
September 1, 2020
4.3 years
February 17, 2016
September 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
5 years
Secondary Outcomes (2)
Overall response rate to primary treatment and salvage treatment
5 years
Progression-free survival
5 years
Study Arms (1)
non-Hodgkin T-cell Lymphoma
Interventions
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
Eligibility Criteria
T-cell non-Hodgkin lymphoma
You may qualify if:
- 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
You may not qualify if:
- Hodgkin lymphoma
- non-Hodgkin B-cell lymphoma
- Immature non-Hodgkin T-cell lymphoma: Precursor T-lymphoblastic lymphoma/leukemia
- Not understanding informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Won seog Kim, PhD
Samsung Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 17, 2016
First Posted
February 25, 2016
Study Start
March 1, 2016
Primary Completion
July 1, 2020
Study Completion
September 1, 2020
Last Updated
September 9, 2020
Record last verified: 2020-09