Observational Study in Japanese Patients With Peripheral... | NCT06422247

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

NCT06422247

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jun 4, 2025Actual

Enrollment

307Actual

Phase

Not provided

Conditions

Peripheral T-cell Lymphoma

Interventions

Systemic therapy

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 5, 2024Actual

Primary Completion Date

Feb 5, 2025Actual

Completion Date

Feb 5, 2025Actual

First Submitted Date

May 15, 2024

First Submission Date that Met QC Criteria

May 15, 2024

First Posted Date

May 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2025

Last Update Posted Date

Jun 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

307Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Relapsed or refractory peripheral T-cell lymphoma initiating second-line systemic therapy			Drug: Systemic therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival (OS)		From baseline until date of death from any cause or last known alive date, assessed up to 6 years

Secondary Outcomes

Measure	Description	Time Frame
Participant baseline demographics		Baseline
Participant baseline clinical characteristics		Baseline
Participant treatment sequence from initial diagnosis

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mebix, Inc		Minato-ku	Tokyo	105-0001	Japan

Label	URL
BMS Clinical Trial Information	View source
FDA Safety Alerts and Recalls	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016411	Lymphoma, T-Cell, Peripheral

Ancestor Terms

ID	Term
D016399	Lymphoma, T-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided