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

• ClinicalTrials.gov Identifier: NCT03742921
• Recruitment Status: Not yet recruiting
• First Posted: November 15, 2018
• Last Update Posted: November 15, 2018
• Sponsor: Celgene
• Information provided by (Responsible Party): Celgene

Study Description

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

Study Design

• 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
• Estimated Study Start Date: November 30, 2018
• Estimated Primary Completion Date: April 17, 2023
• Estimated Study Completion Date: April 17, 2023

Groups and Cohorts

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; Istodax

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

N/A

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure; 1-888-260-1599; clinicaltrialdisclosure@celgene.com

Sponsors and Collaborators

Celgene

Investigators

• Study Director: Jinshu Cho, MD; Celgene

More Information

• 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
• Last Update Posted: November 15, 2018
• Last Verified: November 2018

• 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:

Istodax; Survey; Relapsed or refractory; Peripheral T-Cell Lymphoma

Additional relevant MeSH terms:

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