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

NCT06422247 | Completed FDA Drug

• 1 other identifier: CA073-1019
• Study Type: observational
• Target: 307
• Locations: 1 country
• Sites: 1

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

Conditions

Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  From baseline until date of death from any cause or last known alive date, assessed up to 6 years

Secondary Outcomes (5)

• 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

• 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

Study Arms (1)

Relapsed or refractory peripheral T-cell lymphoma initiating second-line systemic therapy

Drug: Systemic therapy

Interventions

Systemic therapy DRUG

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

Relapsed or refractory peripheral T-cell lymphoma initiating second-line systemic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with peripheral T-cell lymphoma in Japan initiating second-line systemic therapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Mebix, Inc

Minato-ku, Tokyo, 105-0001, Japan

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 20, 2024
• Study Start: April 5, 2024
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)