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

June 3, 2025 updated by: Bristol-Myers Squibb
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

307

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Minato-ku, Tokyo, Japan, 105-0001
        • Mebix, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants with peripheral T-cell lymphoma in Japan initiating second-line systemic therapy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Relapsed or refractory peripheral T-cell lymphoma initiating second-line systemic therapy
Drug: Systemic therapy
Approved peripheral T-cell lymphoma systemic treatments prescribed by the treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: From baseline until date of death from any cause or last known alive date, assessed up to 6 years
From baseline until date of death from any cause or last known alive date, assessed up to 6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Participant baseline clinical characteristics
Time Frame: Baseline
Baseline
Participant baseline demographics
Time Frame: Baseline
Baseline
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
From date of initial diagnosis until death from any cause or last known alive date, assessed up to 6 years
Frequency of treatment regimen by treatment line
Time Frame: End date of each treatment-line of therapy, assessed up to 6 years
End date of each treatment-line of therapy, assessed up to 6 years
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
From date of first-line therapy initiation until death from any cause or last known alive date, assessed up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2024

Primary Completion (Actual)

February 5, 2025

Study Completion (Actual)

February 5, 2025

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

June 3, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA073-1019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peripheral T-cell Lymphoma

Clinical Trials on Systemic therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe