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

Peripheral T-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06422247
• Other study ID #: CA073-1019
• Status: Recruiting
• Start date: June 14, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphoma

Intervention

Drug:
• Systemic therapy
Approved peripheral T-cell lymphoma systemic treatments prescribed by the treating physician

Locations

Country	Name	City	State
Japan	Mebix, Inc	Minato-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)		From baseline until date of death from any cause or last known alive date, assessed up to 6 years
Secondary	Participant baseline demographics		Baseline
Secondary	Participant baseline clinical characteristics		Baseline
Secondary	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
Secondary	Frequency of treatment regimen by treatment line		End date of each treatment-line of therapy, assessed up to 6 years
Secondary	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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls