Observational study of Japanese patients with relapsed peripheral T-cell lymphoma
Observational Study in Japanese Patients With Peripheral T-Cell Lymphoma Who Received Second-Line Therapy
This study looks at how well current treatments work for Japanese patients with relapsed peripheral T-cell lymphoma who have already tried other therapies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Minato-ku, Tokyo) |
| Trial ID | NCT06422247 on ClinicalTrials.gov |
What this trial studies
This study aims to describe the therapeutic practices and prognosis of Japanese patients diagnosed with relapsed or refractory peripheral T-cell lymphoma (PTCL) who have received second-line systemic therapy. It will collect data on treatment outcomes and patient characteristics to better understand the effectiveness of current therapeutic approaches. The study is observational, meaning it will not involve any experimental interventions but will focus on existing treatment regimens and their results in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates are Japanese adults aged 18 and older with a confirmed diagnosis of specific subtypes of peripheral T-cell lymphoma who have received second-line systemic therapy.
Not a fit: Patients who have received unapproved or off-label treatments for peripheral T-cell lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into effective treatment strategies for patients with relapsed peripheral T-cell lymphoma.
How similar studies have performed: While this study is observational and focuses on a specific population, similar studies have provided important data on treatment outcomes in other regions, suggesting potential for valuable findings.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Minato-ku, Tokyo
- Mebix, Inc — Minato-ku, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.