International Extranodal NK/T-cell Lymphoma Project (PINK)

Samsung Medical Center

Status: Completed

Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type

Study type: Observational

Funder types: Other

Identifiers

NCT02386813

2013-03-071

Details and patient eligibility

About

This study is to explore risk factors for poor progression-free survival (PFS) and overall survival (OS) in ENKTL, and establish a prognostic model for ENKTL patients treated with non-anthracycline based treatment.

Full description

This is a retrospective cohort study using anonymized information from patients with ENKTL. The following criteria are required: (1) Patients diagnosed with ENKTL, nasal type between January 1, 1995 and December 31, 2014; (2) Patients treated with non-anthracycline based therapy as an initial treatment. The pathology of initial diagnosis was reviewed by designated pathologists.

Enrollment: 770 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with ENKTL, nasal type
• Patients diagnosed between January 1, 1995 and December 31, 2014
• Patients treated with nonanthracycline-based therapy as the initial treatment after diagnosis
• Nonanthracycline-based therapy includes the following treatments:
• Radiotherapy including concurrent chemoradiation
• Chemotherapy not including anthracycline such as doxorubicin (e.g. SMILE, VIPD) The type of salvage treatment will not be a criterion for exclusion. Thus, patients who had received various kinds of salvage treatment including anthracycline-containing regimens can be included. Patients who had undergone autologous or allogeneic stem cell transplantation can also be included in the analysis if they satisfy the above-mentioned inclusion criteria.

Exclusion criteria

• Patients who had received anthracycline-based therapy, such as CHOP or CHOP-like regimens, as the initial treatment.
• Patients who do not have pathology slides available for central review.

Trial design

770 participants in 2 patient groups

Training cohort

Description:

1. Patients diagnosed with ENKTL, nasal type between January 1, 1995 and December 31, 2013; 2. Patients treated with non-anthracycline based therapy as an initial treatment.

Validation cohort

Description:

1. Patients diagnosed with ENKTL, nasal type between January 1, 1998 and December 31, 2014; 2. Patients treated with non-anthracycline based therapy as an initial treatment.