Spots Global Cancer Trial Database for Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA

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Trial Identification

Brief Title: Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA

Official Title: A Phase 1b/2 Study Evaluating the Safety and Efficacy of Canakinumab With Darbepoetin Alfa in Patients With Lower-Risk Myelodysplastic Syndromes (MDS) Who Have Failed Erythropoietin Stimulating Agents (ESA)

Study ID: NCT04798339

Conditions

Myelodysplastic Syndromes

Interventions

Canakinumab Injection

Darbepoetin Alfa

Study Description

Brief Summary: This study is a multi-institution, open-label, Phase 1b/2 clinical trial evaluating the toxicity and efficacy of canakinumab in combination with darbepoetin alfa in patients with lower-risk MDS who have failed prior treatment with an Erythropoietin Stimulating Agent (ESA)

Detailed Description: This study is a multi-institution, open-label, Phase 1b/2 clinical trial evaluating the toxicity and efficacy of canakinumab in combination with darbepoetin alfa in patients with lower-risk MDS who have failed prior treatment with an ESA. The study will be conducted in two parts, an initial Phase 1b dose escalation study followed by a dose expansion phase.