ISTODAX® for Intravenous Infusion Drug Use Results Survey- Relapsed or Refractory Peripheral T-Cell Lymphoma
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ClinicalTrials.gov Identifier: NCT03742921 |
Recruitment Status :
Recruiting
First Posted : November 15, 2018
Last Update Posted : June 4, 2020
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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 3 years and 6 months
- Planned surveillance period 4 years and 6 months
Condition or disease | Intervention/treatment |
---|---|
Lymphoma, T-Cell, Peripheral | Drug: Istodax |
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 |

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
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Drug: Istodax
Istodax |
- Adverse Events (AEs) [ Time Frame: Up to approximately 5 years ]Number of participants with adverse event

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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 |
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:
N/A

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 ClinicalTrials.gov identifier (NCT number): NCT03742921
Contact: Associate Director Clinical Trial Disclosure | 1-888-260-1599 | clinicaltrialdisclosure@celgene.com |
Japan | |
Nihon Seimei Hospital | Recruiting |
Osaka, Japan, 550-0006 |
Study Director: | Jinshu Cho, MD | Celgene |
Responsible Party: | Celgene |
ClinicalTrials.gov 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 |
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 |
Istodax Survey Relapsed or refractory Peripheral T-Cell Lymphoma |
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Romidepsin Antibiotics, Antineoplastic Antineoplastic Agents |