Lymphoma, T-Cell, PeripheralNCT03742921
ISTODAX® for Intravenous Infusion Drug Use Results Survey- Relapsed or Refractory Peripheral T-Cell Lymphoma
An observational study of Lymphoma, T-Cell, Peripheral, run by Celgene at 1 site in Japan.
Trial summary
To ascertain the safety and efficacy of Istodax® in actual clinical settings in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who receive Istodax. 1. Planned registration period 4 years 2. Planned surveillance period 5 years and 6 months Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma, T-Cell, Peripheral
- What is being tested?
- Istodax
- How many people
- 150 participants
- Where
- 1 siteJapan
- Study dates
- 4 Feb 2019to 31 Oct 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Since the number of patients with PTCL was 48 and 131 in the Japanese and overseas clinical studies, respectively, the number of subjects to be surveyed was established at 130 to allow comparison of results between this survey and Japanese clinical study, or between this survey and overseas clinical study. Among events that were established as the key survey items of this survey, QT interval prolonged had the lowest incidence (3.8%) in the overseas/Japanese clinical studies of Istodax in patients with PTCL. When 130 subjects are collected, it would be possible to collect at least 1 case of an event that occurs at the frequency of 2.3% with a reliability of 95%. Thus, assuming that adverse events occur under the actual use conditions at similar frequencies as in clinical studies, it would be possible to obtain at least 1 case of all events that have been established as the key survey items.
Who may be able to join
- Patients who have been diagnosed with relapsed or refractory PTCL who receive Istodax for the first time.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ISTODAX® for Intravenous Infusion 10mg Drug Use Results Survey - Relapsed or Refractory Peripheral T-Cell Lymphoma
To ascertain the safety and efficacy of Istodax® in actual clinical settings in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who receive Istodax.
- Planned registration period 4 years
- Planned surveillance period 5 years and 6 months
- Conditions
- Lymphoma, T-Cell, Peripheral
- Being tested
- Istodax
- Keywords
- Istodax, Survey, Relapsed or refractory, Peripheral T-Cell Lymphoma
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IstodaxDrug
Istodax
| Study group | Role | What they receive |
|---|---|---|
| Relapsed or Refractory T-Cell Lymphoma patients with Istodax | Among patients with relapsed or refractory peripheral T-Cell lymphoma, patients who received Istodax will be targeted in this surveillance Receives: Drug: Istodax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Number of participants with adverse event
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start4 Feb 2019
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-Cell, PeripheralStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinshu Cho, MD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742921
- Sponsor's protocol ID
- ROMI-PTCL-001
- Other IDs
- U1111-1222-2854
- Status last verified
- Dec 2023
- First submitted
- 13 Nov 2018
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ISTODAX® for Intravenous Infusion 10mg Drug Use Results Survey - Relapsed or Refractory Peripheral T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03742921
- Acronym / sponsor ID
- ROMI-PTCL-001
- Conditions
- Lymphoma, T-Cell, Peripheral
- Keywords
- Istodax, Survey, Relapsed or refractory, Peripheral T-Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 15 Nov 2018 (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.
To ascertain the safety and efficacy of Istodax® in actual clinical settings in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who receive Istodax.
- Planned registration period 4 years
- Planned surveillance period 5 years and 6 months
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsed or Refractory T-Cell Lymphoma patients with Istodax | – | Drug: IstodaxAmong patients with relapsed or refractory peripheral T-Cell lymphoma, patients who received Istodax will be targeted in this surveillance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Since the number of patients with PTCL was 48 and 131 in the Japanese and overseas clinical studies, respectively, the number of subjects to be surveyed was established at 130 to allow comparison of results between this survey and Japanese clinical study, or between this survey and overseas clinical study. Among events that were established as the key survey items of this survey, QT interval prolonged had the lowest incidence (3.8%) in the overseas/Japanese clinical studies of Istodax in patients with PTCL. When 130 subjects are collected, it would be possible to collect at least 1 case of an event that occurs at the frequency of 2.3% with a reliability of 95%. Thus, assuming that adverse events occur under the actual use conditions at similar frequencies as in clinical studies, it would be possible to obtain at least 1 case of all events that have been established as the key survey items.
Key inclusion criteria (1 listed)
- Patients who have been diagnosed with relapsed or refractory PTCL who receive Istodax for the first time.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| IstodaxIstodax | Drug | Relapsed or Refractory T-Cell Lymphoma patients with Istodax |
Primary outcome
Adverse Events (AEs)
Time frame: Up to approximately 5 years
Number of participants with adverse event
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 6 Dec 2023.
Related trials for Lymphoma, T-Cell, Peripheral
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
Not yet recruitingPhase 2
Allogeneic Cell Therapy in Refractory T-Cell Lymphoma
Lymphoma, T Cell, Peripheral
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.
Jinshu Cho, MD study director
Celgene
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 Lymphoma, T-Cell, Peripheral, run by Celgene 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 1 inclusion and 1 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 6 Dec 2023. 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?
Adverse Events (AEs) (time frame: Up to approximately 5 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 6 Dec 2023.