Lymphoma, T-cell, PeripheralNCT05137847
A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
An observational study of Lymphoma, T-cell, Peripheral and Lymphoma, T-cell, Cutaneous, run by Eisai Inc. at 3 sites in Japan.
Trial summary
The primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic dysfunction, visual impairment/color blindness, ischemic heart disease/arrhythmia/cardiac failure… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma, T-cell, Peripheral, Lymphoma, T-cell, Cutaneous
- What is being tested?
- Remitoro
- Type of treatment
- Injection or infusion
- How many people
- 118 participants
- Where
- 3 sitesJapan
- Study dates
- 24 May 2021to 17 Mar 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: Participants with recurrent or refractory PTCL or CTCL administered Remitoro will be included in this study.
Who may be able to join
- 1. Participants with PTCL or CTCL.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Eisai Trial Site 3
Nagoya
Eisai Trial Site 1
Osaka
Eisai Trial Site 2
Tokyo
About this study
Official title: Post-marketing Observational Study of Remitoro® Intravenous Injection 300 μg - Safety of Remitoro in Patients With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
The primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic dysfunction, visual impairment/color blindness, ischemic heart disease/arrhythmia/cardiac failure, and severe skin disorders).
- Being tested
- Remitoro
- Keywords
- Peripheral T cell lymphoma, Cutaneous T cell lymphoma, Remitoro, E7777, Adverse drug reactions
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemitoroDrug
Also called Denileukin diftitox
Intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Remitoro | Participants with recurrent or refractory peripheral T cell lymphoma (PTCL) and cutaneous T cell lymphoma (CTCL) will be administered with Remitoro 9 microgram per kilogram (mcg/kg), intravenous (IV) infusion, over 1 hour once daily for 5 consecutive days followed by 16 days withdrawal period in a 21 day cycle (up to maximum of 8 cycles). The dosage will be adjusted depending on the condition of the participant. All the participants will be observed for up to 24 weeks prospectively. Receives: Drug: Remitoro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with ADR
Incidence of ADR, especially for capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic dysfunction, visual impairment/color blindness, ischemic heart disease/arrhythmia/cardiac failure, and severe skin disorders will be assessed. An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled.
Measured: Up to Week 24
Secondary outcomes (1)
Percentage of Participants With Best Overall Response (BOR)
Percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on physician assessment will be determined. PTCL is evaluated according to revised response criteria for malignant lymphoma (Cheson, 2007). CTCL is evaluated according to clinical endpoints and response criteria in mycosis fungoides and sezary syndrome (Olsen, 2011). CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites.
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start24 May 2021
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, T-cell, PeripheralStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The 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
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137847
- Sponsor's protocol ID
- E7777-M081-501
- Status last verified
- Dec 2023
- First submitted
- 16 Nov 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Publications
Jo T, Matsumoto K, Ishii M, Izutsu K. Safety and Effectiveness of Denileukin Diftitox-cxdl in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma: An All-Case Post-Marketing Study in Japan. Cancer Rep (Hoboken). 2026 Aug;9(8):e70641. doi: 10.1002/cnr2.70641.
PubMed 42605024
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Observational Study of Remitoro® Intravenous Injection 300 μg - Safety of Remitoro in Patients With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
- ClinicalTrials.gov ID
- NCT05137847
- Acronym / sponsor ID
- E7777-M081-501
- Keywords
- Peripheral T cell lymphoma, Cutaneous T cell lymphoma, Remitoro, E7777, Adverse drug reactions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 24 May 2021 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 30 Nov 2021 (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 primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic dysfunction, visual impairment/color blindness, ischemic heart disease/arrhythmia/cardiac failure, and severe skin disorders).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remitoro | – | Drug: RemitoroParticipants with recurrent or refractory peripheral T cell lymphoma (PTCL) and cutaneous T cell lymphoma (CTCL) will be administered with Remitoro 9 microgram per kilogram (mcg/kg), intravenous (IV) infusion, over 1 hour once daily for 5 consecutive days followed by 16 days withdrawal period in a 21 day cycle (up to maximum of 8 cycles). The dosage will be adjusted depending on the condition of the participant. All the participants will be observed for up to 24 weeks prospectively. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with recurrent or refractory PTCL or CTCL administered Remitoro will be included in this study.
Key inclusion criteria (1 listed)
- 1. Participants with PTCL or CTCL.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| RemitoroAlso: Denileukin diftitoxIntravenous infusion. | Drug | Remitoro |
Primary outcome
Percentage of Participants with ADR
Time frame: Up to Week 24
Incidence of ADR, especially for capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic dysfunction, visual impairment/color blindness, ischemic heart disease/arrhythmia/cardiac failure, and severe skin disorders will be assessed. An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled.
1 secondary outcome
Percentage of Participants With Best Overall Response (BOR)
Time frame: Up to Week 24
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 12 Dec 2023.
- Derived from this study: PubMed 42605024Jo T, Matsumoto K, Ishii M, Izutsu K. Safety and Effectiveness of Denileukin Diftitox-cxdl in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma: An All-Case Post-Marketing Study in Japan. Cancer Rep (Hoboken). 2026 Aug;9(8):e70641. doi: 10.1002/cnr2.70641.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 and Lymphoma, T-cell, Cutaneous, run by Eisai Inc. at 3 sites 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 0 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 12 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 3 sites 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?
Percentage of Participants with ADR (time frame: Up to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05137847, which also lists 1 linked publication.
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 12 Dec 2023.