A Study to Analyze the Occurrence of Transformation From Myelodysplastic Syndrome to Acute Myeloid Leukemia in Patients With Myelodysplastic Syndrome Who Received Revlimid® 5 mg Capsules and Who Are Continuing or no Longer Continuing Revlimid Treatment
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|ClinicalTrials.gov Identifier: NCT02921815|
Recruitment Status : Active, not recruiting
First Posted : October 3, 2016
Last Update Posted : June 5, 2019
To analyze the occurrence of transformation from myelodysplastic syndrome (MDS) to acute myeloid leukemia (hereinafter referred to as transformation from MDS to AML) in patients with myelodysplastic syndrome with a deletion 5q cytogenetic abnormality (hereinafter referred to as del(5q)MDS) who received Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) and who are continuing or no longer continuing Revlimid treatment.
- Planned registration period This period started on the date of initial marketing of Revlimid and will end on the day when the appropriateness of enrollment is assessed for all del(5qMDS) patients in the all-case surveillance.
- Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid.
|Condition or disease|
|Myelodysplastic Syndromes Leukemia, Myeloid, Acute|
|Study Type :||Observational|
|Actual Enrollment :||84 participants|
|Official Title:||Revlimid 5 mg Capsules Special Use-results Surveillance of Transformation to Acute Myeloid Leukemia|
|Actual Study Start Date :||March 3, 2011|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Patients with myeloid leukemia
All del(5q) Myelodysplastic syndrome (MDS) patients in the all-case surveillance in whom transformation to acute myeloid leukemia has not been documented at the end of the observation period of the all-case surveillance.
- Adverse Events (AEs) [ Time Frame: 3 years ]Number of participants with adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921815
|Kobe, Hyogo, Japan, 651-0072|
|Study Director:||Jinshu Cho||Celgene|