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

NCT ID: NCT02691351

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2020-09-30

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.

Conditions

Non-Hodgkin T-cell Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

non-Hodgkin T-cell Lymphoma

Prospective Registry

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Won Seog Kim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Won seog Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2015-11-070

Identifier Type: -

Identifier Source: org_study_id