drugset
drugset / Trial / NCT04798339

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

NCT04798339 ↗

Phase 1/2 Active not recruiting 13 enrolled H. Lee Moffitt Cancer Center and Research Institute Novartis Pharmaceuticals · collab
Non-randomizedSequentialOpen-labelTreatment

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)

Timeline

Start
2021-03-30
Primary completion
2025-05-26
Completion
2026-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Canakinumab Monoclonal antibody 150 mg Subcutaneous
Subject Canakinumab Monoclonal antibody 300 mg Subcutaneous
Background Darbepoetin alfa Protein / enzyme biologic 300 mg Subcutaneous

Indications

myelodysplastic syndrome