Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)

Lymphoma Clinical Trial

Official title:

Revlimid® Capsules Drug Use-results Surveillance Relapsed or Refractory Adult T-cell Leukemia Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03098589
• Other study ID #: NIS-Celgene-JP-PMS-004
• Status: Recruiting
• Start date: May 30, 2017
• Est. completion date: September 27, 2023

Study information

• Verified date: June 2022
• Source: Celgene
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com, Study
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory Adult T-cell Leukemia Lymphoma (ATLL)).

1. Planned registration period 3 years

2. Planned surveillance period 4 years and 6 months after a month after the approval for partial changes in the approved items is granted for relapsed or refractory ATLL

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 27, 2023
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Relapsed or Refractory Adult T-cell Leukemia Lymphoma

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• Revlimid
Revlimid

Locations

Country	Name	City	State
Japan	ASO KK Iizuka Hospital	Iizuka	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (AEs)	Number of participants with adverse events	Up to approximately 4 years