NCT02775903

An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Azacitidine	Administered by subcutaneous injection on Days 1 to 7 of each 4-week treatment cycle.
BIOLOGICAL	Durvalumab	Administered by intravenous infusion on Day 1 of every 4-week treatment cycle.

Timeline

• Start date: 2016-06-03
• Primary completion: 2018-12-31
• Completion: 2021-12-27
• First posted: 2016-05-18
• Last updated: 2023-02-28
• Results posted: 2020-05-04

Locations

103 sites across 12 countries: United States, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom