Peripheral T-cell LymphomaNCT06422247
Observational Study in Japanese Patients With Peripheral T-Cell Lymphoma Who Received Second-Line Therapy
An observational study of Peripheral T-cell Lymphoma, run by Bristol-Myers Squibb at 1 site in Japan.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- Systemic therapy
- How many people
- 307 participants
- Where
- 1 siteJapan
- Study dates
- 5 Apr 2024to 5 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with peripheral T-cell lymphoma in Japan initiating second-line systemic therapy
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Systemic therapy
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic therapyDrug
Approved peripheral T-cell lymphoma systemic treatments prescribed by the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Relapsed or refractory peripheral T-cell lymphoma initiating second-line systemic therapy | Not described Receives: Drug: Systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: 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
Measured: Baseline
Participant baseline clinical characteristics
Measured: Baseline
Participant treatment sequence from initial diagnosis
Measured: 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
Measured: End date of each treatment-line of therapy, assessed up to 6 years
Time to next treatment line or death (TTNT)
Measured: From date of first-line therapy initiation until death from any cause or last known alive date, assessed up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start5 Apr 2024
- Primary completion5 Feb 2025
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422247
- Sponsor's protocol ID
- CA073-1019
- Status last verified
- Jun 2025
- First submitted
- 15 May 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study in Japanese Patients With Peripheral T-Cell Lymphoma Who Received Second-Line Therapy
- ClinicalTrials.gov ID
- NCT06422247
- Acronym / sponsor ID
- CA073-1019
- Conditions
- Peripheral T-cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsed or refractory peripheral T-cell lymphoma initiating second-line systemic therapy | – | Drug: Systemic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with peripheral T-cell lymphoma in Japan initiating second-line systemic therapy
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic therapyApproved peripheral T-cell lymphoma systemic treatments prescribed by the treating physician | Drug | Relapsed or refractory peripheral T-cell lymphoma initiating second-line systemic therapy |
Primary outcome
Overall survival (OS)
Time frame: From baseline until date of death from any cause or last known alive date, assessed up to 6 years
5 secondary outcomes
Participant baseline demographics
Time frame: Baseline
Participant baseline clinical characteristics
Time frame: Baseline
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
Frequency of treatment regimen by treatment line
Time frame: End date of each treatment-line of therapy, assessed up to 6 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral T-cell Lymphoma, run by Bristol-Myers Squibb at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.