Observational Study in Japanese Patients With Peripheral T-Cell Lymphoma Who Received Second-Line Therapy
Recruiting
- Conditions
- Peripheral T-cell Lymphoma
- Interventions
- Drug: Systemic therapy
- Registration Number
- NCT06422247
- Lead Sponsor
- Bristol-Myers Squibb
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Relapsed or refractory peripheral T-cell lymphoma initiating second-line systemic therapy Systemic therapy -
- Primary Outcome Measures
Name Time Method Overall survival (OS) From baseline until date of death from any cause or last known alive date, assessed up to 6 years
- Secondary Outcome Measures
Name Time Method Frequency of treatment regimen by treatment line End 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 Participant baseline demographics Baseline Participant baseline clinical characteristics Baseline Participant treatment sequence from initial diagnosis From date of initial diagnosis until death from any cause or last known alive date, assessed up to 6 years
Trial Locations
- Locations (1)
Mebix, Inc
🇯🇵Minato-ku, Tokyo, Japan