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OpenTrials
Completed

NCT Number: NCT06422247

Observational Study in Japanese Patients With Peripheral T-Cell Lymphoma Who Received Second-Line Therapy

The purpose of this study is to describe the therapeutic practices and the prognosis of patients with relapsed or refractory peripheral T-cell lymphoma in Japan

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Key information

Conditions

Peripheral T-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mebix, Inc

Minato-ku, Tokyo, 105-0001, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female participants with a confirmed diagnosis of the specific subtypes of peripheral T-cell lymphoma (PTCL) according to The World Health Organization (WHO) classification of lymphoid neoplasm, 4th edition defined by WHO and International Agency for Research on Cancer (IARC).
  • Participates aged ≥18 years of age at diagnosis of PTCL.
  • Participates who have been treated with a systemic therapy for PTCL and have initiated a systemic therapy as a second-line therapy for relapsed or refractory PTCL between April 1, 2018 and March 31, 2023.

Exclusion criteria

  • Participates who have medical history of peripheral T-cell lymphoma (PTCL) treatment by unapproved drug in Japan as of 31 March 2024 or off-label drug for PTCL in Japan as of 31 March 2024.
  • Participates who have medical history of participation to a separately defined registration study for regulatory approval in PTCL.
  • Participates who have medical history of PTCL treatment in a separately defined clinical study with intervention by on-label regimen for PTCL.
  • Participates judged to be inappropriate for enrollment in this study by the site investigator.

Treatment and study plan

Systemic therapy

Drug

Approved peripheral T-cell lymphoma systemic treatments prescribed by the treating physician

Primary outcomes

  1. Overall survival (OS)

    Time frame: From baseline until date of death from any cause or last known alive date, assessed up to 6 years

Secondary outcomes

  1. Participant baseline demographics

    Time frame: Baseline

  2. Participant baseline clinical characteristics

    Time frame: Baseline

  3. Participant treatment sequence from initial diagnosis

    Time frame: From date of initial diagnosis until death from any cause or last known alive date, assessed up to 6 years

  4. Frequency of treatment regimen by treatment line

    Time frame: End date of each treatment-line of therapy, assessed up to 6 years

  5. Time to next treatment line or death (TTNT)

    Time frame: From date of first-line therapy initiation until death from any cause or last known alive date, assessed up to 6 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 20, 2024
Registry last updated
Jun 4, 2025

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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