Revlimid® Capsules General Drug Use-results Surveillance (Relapsed or Refractory FL and MZL)

Recruiting

• Conditions: Lymphoma Nonhodgkin

• Registration Number: NCT04618081
• Lead Sponsor: Celgene

Brief Summary

To ascertain the safety of Revlimid® Capsules 2.5 mg or 5 mg under the actual use conditions in patients who received R2 combination therapy with the drug and rituximab for the first time for relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL).

In particular, this surveillance will collect only information of occurrence state and treatment methods on bone marrow depression (neutropenia), which is specified as a safety specification, as well as on tumor flare, for which attention should be called.

1. Planned registration period 1.5 years

2. Planned surveillance period 3 years from the start of this survey

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-31
• Study First Submitted QC: 2020-10-31
• Study First Posted: 2020-11-05
• Study Start: 2020-12-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-03-27
• Study Completion: 2025-03-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Events (AEs)	Up to approximately 3 years	Number of participants with adverse events

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Japan, Japan