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

Completed

• Conditions: Lymphoma
• Interventions: Drug: Revlimid

• Registration Number: NCT03098589
• Lead Sponsor: Celgene

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Study Start: 2017-05-30
• Primary Completion: 2020-09-18
• Study Completion: 2020-09-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1149

Inclusion Criteria

• Relapsed or Refractory Adult T-cell Leukemia Lymphoma

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with T-cell leukemia lymphoma treated with Revlimid	Revlimid	Among patients with relapsed or refractory adult T-cell leukemia lymphoma, patients who received Revlimid will be targeted in this surveillance

Primary Outcome Measures

Name	Time	Method
Adverse Events (AEs)	Up to approximately 4 years	Number of participants with adverse events

Trial Locations

Locations (1)

ASO KK Iizuka Hospital; 🇯🇵 Iizuka, Fukuoka, Japan