At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 Years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)
In Brief
A Phase 2 clinical trial evaluating Azacitidine and Durvalumab for Leukemia, Myeloid, Acute and Myelodysplastic Syndromes. Completed, enrolled 213 participants across 103 sites in 12 countries.
Detailed Summary
The primary objective of this study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in adults with previously untreated, higher risk MDS who are not eligible for HSCT or in adults ≥ 65 years old with previously untreated AML who are not eligible for HSCT, with intermediate or poor cytogenetic risk.
Study Details
Timeline
Interventions
Administered by subcutaneous injection on Days 1 to 7 of each 4-week treatment cycle.
Administered by intravenous infusion on Day 1 of every 4-week treatment cycle.