Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: Post Marketing Surveillance on Safety Evaluation of REVLIMID® (Lenalidomide) Treatment of Myelodysplastic Syndromes Associated With a Deletion 5q or Mantle Cell Lymphoma in Korea
Study ID: NCT04036448
Interventions
Study Description
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-marketing surveillance, which will be conducted by collecting the safety information of REVLIMID® for new indications in routine clinical practice in Korea. Six-Hundred (600) adult patients, who start with REVLIMID® treatment based on the approved local package insert (PI) of REVLIMID® during routine clinical practice in Korea and have indications noted below. 1. Patients with transfusion-dependent anemia due to IPSS low- or intermediate-1-risk Myelodysplastic Syndromes associated with a deletion 5q cytogenetic abnormality (del \[5q\] MDS) 2. Patients with mantle cell lymphoma who have received at least one prior therapy (rrMCL) 3. Previously treated follicular lymphoma (FL), in combination with rituximab (an anti-CD20 antibody)
Detailed Description:
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - S02, Seoul-si, Seoul Teugbyeolsi, Korea, Republic of
Hallym University Medical Center, Anyang, , Korea, Republic of
Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Local Institution - S03, Daegu, , Korea, Republic of
Local Institution - S07, Daegu, , Korea, Republic of
Local Institution - S11, Goyang, , Korea, Republic of
Local Institution - S04, Hwasun-gun, , Korea, Republic of
CHONNAM National University Hwasun Hospital, Hwasun, , Korea, Republic of
Naitonal Health Insurance Service Ilsan hospital, Ilsan, , Korea, Republic of
Gachon University Gil Mdical Center, Incheon, , Korea, Republic of
Local Institution - S09, Incheon, , Korea, Republic of
Local Institution - S10, Jeonju-si, , Korea, Republic of
Jeonbuk National University Hospital, JeonJu, , Korea, Republic of
Local Institution - S05, Seoul, , Korea, Republic of
Local Institution - S06, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Local Institution - S08, Seoul, , Korea, Republic of
Yonsei University Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Local Institution - S12, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Local Institution - S01, Seoul, , Korea, Republic of
The Catholic University, St. Mary's Hospital, Seoul, , Korea, Republic of
Local Institution - S14, Wonju, , Korea, Republic of
Wonju Severance Christian Hospital, Wonju, , Korea, Republic of
Contact Details
Name: Claire (Myoung-Jin) Lee, Medical doctor
Affiliation: Celgene Korea
Role: STUDY_DIRECTOR
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