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

Bristol-Myers Squibb307 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

307

Conditions

Peripheral T-cell Lymphoma

Interventions

Systemic therapyDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mebix, Inc

Minato-ku, Tokyo, Japan

Outcomes

Primary Outcomes

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

Participant baseline demographics

Time frame: Baseline

Participant baseline clinical characteristics

Time frame: 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

Frequency of treatment regimen by treatment line

Time frame: 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

Data from ClinicalTrials.gov

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