Risk Stratification of Nodal PTCL

Angioimmunoblastic T-cell Lymphoma Clinical Trial

Official title:

Multicenter Study to Assess the Prognostic Significances of NCCN-IPI and Post-treatment PET Results in Patients With Newly Diagnosed Nodal PTCL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040206
• Other study ID #: nodal PTCL
• Status: Completed
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: August 2019
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is to investigate the prognostic significance of enhanced International Prognostic Index (NCCN-IPI) and post-treatment PET results in patients with newly diagnosed nodal peripheral T-cell lymphoma (PTCL), and establish a risk stratification model for nodal PTCL patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with nodal PTCLs (PTCL, NOS; Angioimmunblastic T-cell lymphoma; anaplastic large cell lymphoma [ALCL], anaplastic lymphoma kinase [ALK]-negative)

• Patients diagnosed with between January 1, 2004 and April 30, 2016

• initially treated with curative intent

• Patients with standard 18F-fluorodeoxyglucose (FDG) PET or PET-CT data at the time of diagnosis and at the end of primary treatment

Exclusion Criteria:

• Patients diagnosed with extranodal PTCLs, including followings (extranodal NK/T-cell lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell lymphoma; subcutaneous panniculitis-like T-cell lymphoma; EBV-positive T-cell lymphoproliferative childhood disorders, and primary cutaneous lymphomas)

• Patients with ALCL-ALK+

• Patients who do not have 18F-FDG PET or PET-CT data either at diagnosis or at the end of treatment available for review

Related Conditions & MeSH terms

• Anaplastic Large Cell Lymphoma, ALK-negative
• Angioimmunoblastic T-cell Lymphoma
• Lymphoma
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-Cell Lymphoma, Not Otherwise Specified

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk Nationla University Hospital	Jeonju

Sponsors (12)

Lead Sponsor	Collaborator
Chonbuk National University Hospital	Chonnam National University Hospital, Chungnam National University Hospital, Dong-A University Hospital, Inje University, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Korea University Guro Hospital, Kyungpook National University, Pusan National University Hospital, Samsung Medical Center, Yeungnam University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	Time between the date of diagnosis and any kinds of death or disease relapse/progrression	5 year
Secondary	overall survival	Time between the date of diagnosis and any kinds of death	5 year