International Extranodal NK/T-cell Lymphoma Project

Extranodal NK/T-cell Lymphoma, Nasal Type Clinical Trial

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Official title:

International Extranodal NK/T-cell Lymphoma Project: Prognostic Factors in the Era of Nonanthracycline-based Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386813
• Other study ID #: 2013-03-071
• Status: Completed
• Phase: N/A
• First received: March 6, 2015
• Last updated: April 8, 2017
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: April 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 770
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Extranodal NK/T-cell Lymphoma, Nasal Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Locations

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

Sponsors (34)

Lead Sponsor

Collaborator

Samsung Medical Center

Arnaud Jaccard, Asia Lymphoma Study Group, Cheolwon Suh, Chul Won Choi, Consortium for Improving Survival of Lymphoma, Deok-Hwan Yang, Dok Hyun Yoon, Dong-Yeop Shin, Francesco d’Amore, Fumihiro Ishida, Gyeong-Won Lee, Huangming Hong, Jae-Cheol Jo, Jin Seok Kim, Kian Meng Chang, Kiyeun Kim, Lymphoma Study Association, Norbert Schmitz, Ranjana Advani, Ritsuro Suzuki, Seok Jin Kim, Seong Hyun Jeong, Sin-Ho Jung, Soon Thye Lim, Tohru Murayama, Tong-Yu Lin, Tsai-Yun Chen, Wee Joo Chng, Won-Sik Lee, Yasuhiro Oki, Yok Lam Kwong, Yong Park, Yoshinobu Maeda

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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