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

Non-Hodgkin T-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02691351
• Other study ID #: 2015-11-070
• Status: Completed
• Start date: March 2016
• Est. completion date: September 2020

Study information

• Verified date: September 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Non-Hodgkin T-cell Lymphoma

Intervention

Other:
• Prospective Registry
Survival and disease status follow-up at 1st primary treatment, 1st salvage treatment and 2nd salvage treatment Regimen Response Evaluation SUSAR(Suspected, Unexpected, Serious, Adverse Reaction) collection

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		5 years
Secondary	Overall response rate to primary treatment and salvage treatment		5 years
Secondary	Progression-free survival		5 years