## Protocol Section
### Identification Module
**NCT ID:** NCT06422247

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

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

#### Organization Study ID Info
**ID:** CA073-1019
#### Organization
**Class:** INDUSTRY
**Full Name:** Bristol-Myers Squibb
### Status Module
#### Completion Date
**Date:** 2025-04-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-04-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-14

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bristol-Myers Squibb

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**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 Module

**Conditions:**

- Peripheral T-cell Lymphoma

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Systemic therapy

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

### Interventions

#### Intervention 1

**Arm Group Labels:**

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

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

**Name:** Systemic therapy

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Overall survival (OS)

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

#### Secondary Outcomes

**Measure:** Participant baseline demographics

**Time Frame:** Baseline

**Measure:** Participant baseline clinical characteristics

**Time Frame:** Baseline

**Measure:** Participant treatment sequence from initial diagnosis

**Time Frame:** From date of initial diagnosis until death from any cause or last known alive date, assessed up to 6 years

**Measure:** Frequency of treatment regimen by treatment line

**Time Frame:** End date of each treatment-line of therapy, assessed up to 6 years

**Measure:** Time to next treatment line or death (TTNT)

**Time Frame:** From date of first-line therapy initiation until death from any cause or last known alive date, assessed up to 6 years

### 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult participants with peripheral T-cell lymphoma in Japan initiating second-line systemic therapy

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Clinical.Trials@bms.com

**Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com

**Phone:** 855-907-3286

**Role:** CONTACT

**Contact 2:**

**Name:** First line of the email MUST contain NCT # and Site #.

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Minato-ku

**Country:** Japan

**Facility:** Mebix, Inc

**State:** Tokyo

**Status:** RECRUITING

**Zip:** 105-0001

#### Overall Officials

**Official 1:**

**Affiliation:** Bristol-Myers Squibb

**Name:** Bristol-Myers Squibb

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** BMS Clinical Trial Information

**URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

**Label:** FDA Safety Alerts and Recalls

**URL:** https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

- ID: D000008228

- Term: Lymphoma, Non-Hodgkin

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11220

- Name: Lymphoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: M18829

- Name: Lymphoma, T-Cell

- Relevance: HIGH

- As Found: T-cell Lymphoma

- ID: M18833

- Name: Lymphoma, T-Cell, Peripheral

- Relevance: HIGH

- As Found: Peripheral T-cell Lymphoma

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11222

- Name: Lymphoma, Non-Hodgkin

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: T4496

- Name: Peripheral T-cell Lymphoma

- Relevance: HIGH

- As Found: Peripheral T-cell Lymphoma

### Condition Browse Module - Meshes

- ID: D000008223

- Term: Lymphoma

- ID: D000016399

- Term: Lymphoma, T-Cell

- ID: D000016411

- Term: Lymphoma, T-Cell, Peripheral

### Misc Info Module

- Version Holder: 2024-05-31
