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ISTODAX® for Intravenous Infusion Drug Use Results Survey- Relapsed or Refractory Peripheral T-Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03742921
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : June 4, 2020
Information provided by (Responsible Party):

Brief 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 3 years and 6 months
  2. Planned surveillance period 4 years and 6 months

Condition or disease Intervention/treatment
Lymphoma, T-Cell, Peripheral Drug: Istodax

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: ISTODAX® for Intravenous Infusion 10mg Drug Use Results Survey - Relapsed or Refractory Peripheral T-Cell Lymphoma
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : April 17, 2023
Estimated Study Completion Date : April 17, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Romidepsin

Group/Cohort Intervention/treatment
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
Drug: Istodax

Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Up to approximately 5 years ]
    Number of participants with adverse event

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.


Inclusion Criteria:

- Patients who have been diagnosed with relapsed or refractory PTCL who receive Istodax for the first time.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03742921

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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599

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Nihon Seimei Hospital Recruiting
Osaka, Japan, 550-0006
Sponsors and Collaborators
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Study Director: Jinshu Cho, MD Celgene
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Responsible Party: Celgene Identifier: NCT03742921    
Other Study ID Numbers: ROMI-PTCL-001
U1111-1222-2854 ( Registry Identifier: WHO )
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Celgene:
Relapsed or refractory
Peripheral T-Cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibiotics, Antineoplastic
Antineoplastic Agents