Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06004765
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-22
First Post:
2023-08-16
Brief Title:
Efficacy and Safety of Lenalidomide Combined With Azacitidine vs Azacitidine in the Treatment of MDS-RS
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Prospective Single-center Study on the Efficacy and Safety of Lenalidomide Combined With Azacitidine vs Azacitidine in the Treatment of MDS-RS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
At present the main therapies for myelodysplastic syndromes with ring sideroblasts MDS-RS are red blood cell and platelet transfusion erythropoietin EPO androgen and iron chelation therapy Lenalidomide is an immunomodulator with multiple mechanisms including direct targeting of MDS clones immunomodulation erythropoiesis restoration and angiogenesis inhibition A Phase III randomized placebo-controlled trial of oral azacitidine AZA in lower-risk MDS reported higher rates of hemoglobin and platelet hematological improvement in patients with AZA monotherapy Therefore this study intended to investigate the efficacy and safety of lenalidomide and sequential AZA in the treatment of refractory MDS-RS versus azacitidine monotherapy
Detailed Description:
Myelodysplastic neoplasms MDS are heterogeneous clonal disorders of stem cells that result in peripheral blood cytopenia and ineffective hematopoiesis with the potential risk of the development of acute myeloid leukemia AML Most patients with myelodysplastic syndromes with ring sideroblasts MDS-RS are stratified into lower-risk groups by the revised International Prognostic Scoring System IPSS At present the main therapies for MDS-RS are red blood cell and platelet transfusion erythropoietin EPO androgen and iron chelation therapy Lenalidomide is an immunomodulator with multiple mechanisms including direct targeting of MDS clones immunomodulation erythropoiesis restoration and angiogenesis inhibition Hypomethylating agents HMA like azacytidine AZA and decitabine DEC have been shown to improve survival or delay disease progression in high-risk MDS A Phase III randomized placebo-controlled trial of oral AZA in lower-risk MDS reported higher rates of hemoglobin and platelet hematological improvement in patients with AZA monotherapy 243 vs 65 Therefore this study intended to investigate the efficacy and safety of lenalidomide and sequential azacitidine in the treatment of refractory MDS-RS versus azacitidine monotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None