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Completed

NCT Number: NCT02386813

International Extranodal NK/T-cell Lymphoma Project

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center, Seoul, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 5 year

    Time between the date of diagnosis and any kinds of death

Secondary outcomes

  1. Progression-free survival

    Time frame: 5 year

    Time between the date of diagnosis and any kinds of death or relapse/progression

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: PINK

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 12, 2015
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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