Status:
COMPLETED
A Non-interventional Study of REVLIMID® (Lenalidomide) Treatment of IPSS Low- or Intermediate-1-risk Myelodysplastic Syndromes Associated With a Deletion 5q or Refractory/Relapsed Mantle Cell Lymphoma in Korea
Lead Sponsor:
Celgene
Conditions:
Myelodysplastic Syndromes
Lymphoma, Mantle-Cell
Eligibility:
All Genders
19+ years
Brief Summary
The Drug Use Examination (DUE) is planned and designed for the safety evaluation of new indications after the approval of a new drug in Korea. This DUE is a non-interventional, observational and post...
Eligibility Criteria
Inclusion
- Treatment of patients with transfusion-dependent anemia due to IPSS low- or intermediate-1-risk Myelodysplastic Syndromes associated with a deletion 5q cytogenetic abnormality according to International scoring system for evaluating prognosis in myelodysplastic syndromes according to IPSS or
- Treatment of patients with mantle cell lymphoma who have received at least one prior therapy
- Previously treated follicular lymphoma (FL)
- Patients who are registered in Celgene Risk Management Program" in Korea
Exclusion
- Pregnancy or females of childbearing potential
- Hypersensitivity to the active substance or to any of the excipients (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS)
- Patients with genetic disorder (e.g., galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption)
Key Trial Info
Start Date :
November 28 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 15 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04036448
Start Date
November 28 2019
End Date
August 15 2023
Last Update
March 11 2025
Active Locations (26)
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1
Local Institution - S02
Seoul, Seoul Teugbyeolsi, South Korea, 05505
2
Hallym University Medical Center
Anyang, South Korea, 14068
3
Keimyung University Dongsan Hospital
Daegu, South Korea, 41931
4
Kyungpook National University Hospital
Daegu, South Korea, 41944