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

Launched by BRISTOL-MYERS SQUIBB · May 15, 2024

Keywords

ClinConnect Summary

This clinical trial is observing patients in Japan who have a type of cancer called peripheral T-cell lymphoma (PTCL) that has come back or hasn’t responded to previous treatments. The main goal of the study is to learn more about the treatment methods used and how well patients are doing after they start a second type of therapy. The researchers want to gather information from patients who have started this second-line therapy between April 2018 and March 2023.

To participate in this study, individuals must be at least 18 years old and have a confirmed diagnosis of specific subtypes of PTCL. They should have received prior treatment for their lymphoma and be currently undergoing a second treatment. However, people who have been treated with certain unapproved drugs or are already part of another study for PTCL are not eligible. If someone joins the study, they will help researchers better understand how PTCL is treated and what outcomes patients can expect, which can help improve future care for others facing this condition.

Gender

ALL

Eligibility 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.

Trial Officials