Clinical trial NCT04036448: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndromes
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Keywords: REVLIMID®
Lenalidomide
Observational
Korea
Post Marketing Surveillance[PMS]
Relapsed and Refractory Mantle cell lymphoma
IPSS Low- or intermediate-1-risk Myelodysplastic Syndromes Associated with a deletion 5q
previously treated follicular lymphoma (FL) in Korea
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2019-07-29
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 for IPSS low- or intermediate-1-risk del (5q) MDS, rrMCL and previously treated Follicular lymphoma.

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)


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

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)

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: From enrollment until at least 28 days after completion of study treatment
Secondary outcomes:
measure: Adverse events (AEs)
timeFrame: From enrollment until at least 28 days after completion of study treatment
measure: To evaluate the effectiveness of REVLIMID® treatment in patients with IPSS low- or intermediate-1-risk del (5q) MDS
timeFrame: Up to 4 years of Revlimid treatment period
measure: To evaluate the effectiveness of REVLIMID® treatment in patients with rrMCL
timeFrame: Up to 4 years of Revlimid treatment period
measure: To evaluate the effectiveness of REVLIMID® treatment in patients with previously treated FL
timeFrame: Up to 4 years of Revlimid treatment period
Other outcomes:
Locations:
city: Seoul-si
country: Korea, Republic of
facility: Local Institution - S02
state: Seoul Teugbyeolsi
city: Anyang
country: Korea, Republic of
facility: Hallym University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Local Institution - S03
city: Daegu
country: Korea, Republic of
facility: Local Institution - S07
city: Goyang
country: Korea, Republic of
facility: Local Institution - S11
city: Hwasun-gun
country: Korea, Republic of
facility: Local Institution - S04
city: Hwasun
country: Korea, Republic of
facility: CHONNAM National University Hwasun Hospital
city: Ilsan
country: Korea, Republic of
facility: Naitonal Health Insurance Service Ilsan hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Mdical Center
city: Incheon
country: Korea, Republic of
facility: Local Institution - S09
city: Jeonju-si
country: Korea, Republic of
facility: Local Institution - S10
city: JeonJu
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Local Institution - S05
city: Seoul
country: Korea, Republic of
facility: Local Institution - S06
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Local Institution - S08
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Local Institution - S12
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Local Institution - S01
city: Seoul
country: Korea, Republic of
facility: The Catholic University, St. Mary's Hospital
city: Wonju
country: Korea, Republic of
facility: Local Institution - S14
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Celgene Korea
name: Claire (Myoung-Jin) Lee, Medical doctor
role: STUDY_DIRECTOR
References: