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

• Sponsor: Celgene (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03742921
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Anticipated Duration (Months): 62.4
• Patients Per Site Per Month: 2.1

Study Details

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 4 years

2. Planned surveillance period 5 years and 6 months

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, T-Cell, Peripheral	Drug: Istodax

Study Design

• Study Type: Observational
• Anticipated 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: Feb 4, 2019
• Anticipated Primary Completion Date: Apr 17, 2024
• Anticipated Study Completion Date: Apr 17, 2024

Arms and Interventions

Arm	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) [Up to approximately 5 years]

   Number of participants with adverse event

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Nihon Seimei Hospital	Osaka		Japan	550-0006

Sponsors and Collaborators

• Celgene

Investigators

• Study Director: Jinshu Cho, MD, Celgene

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT03742921
• Other Study ID Numbers: ROMI-PTCL-001; U1111-1222-2854
• First Posted: Nov 15, 2018
• Last Update Posted: Jun 4, 2021
• Last Verified: May 1, 2021

• 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; Romidepsin

Study Results

No Results Posted as of Jun 4, 2021