NCT03699384

Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD)

A Phase I/II Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I / II study. The purposes of this study are to: 1) find out what effects, good and/or bad, the combination of the experimental drug avelumab and the drug azacitidine has on people with AML and MRD, and 2) test if the two drugs, avelumab and azacitidine, are effective in getting rid of AML MRD when the drugs are given together in combination.

Conditions

• Acute Myeloid Leukemia (AML)
• Minimal Residual Disease

Interventions

Type	Name	Description
DRUG	Azacitidine	AZA 75 mg/m\^2 SC or IV D 1-7 28 day cycle x 1
DRUG	Avelumab	Avelumab 10mg/kg IV D1, D15, 28d cycle Until progression or MRD If MRD-, tx x 1 yr or go to allo SCT

Timeline

• Start date: 2018-10-03
• Primary completion: 2019-02-18
• Completion: 2019-02-18
• First posted: 2018-10-09
• Last updated: 2019-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study