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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06422247
Enrollment
307
Registered
2024-05-20
Start date
2024-04-05
Completion date
2025-02-05
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral T-cell Lymphoma

Brief summary

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

Interventions

DRUGSystemic therapy

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

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Overall survival (OS)From baseline until date of death from any cause or last known alive date, assessed up to 6 years

Secondary

MeasureTime frame
Participant treatment sequence from initial diagnosisFrom date of initial diagnosis until death from any cause or last known alive date, assessed up to 6 years
Participant baseline demographicsBaseline
Participant baseline clinical characteristicsBaseline
Frequency of treatment regimen by treatment lineEnd date of each treatment-line of therapy, assessed up to 6 years
Time to next treatment line or death (TTNT)From date of first-line therapy initiation until death from any cause or last known alive date, assessed up to 6 years

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026