NCT03395873

Avelumab With Decitabine as First Line for AML Treatment of Patients With AML, Who Are Unfit for Intensive Chemotherapy

A Phase I Study of Avelumab in Combination With Decitabine as First Line Treatment of Patients With AML, Who Are Unfit for Intensive Chemotherapy

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to test the safety of combination treatment with Avelumab and Decitabine in newly diagnosed AML patients who are unfit for intensive induction chemotherapy.

Detailed description

This is a single arm, open label phase I study with expansion to evaluate safety and tolerability of Avelumab in combination with Decitabine in patients with untreated AML, who are unfit for intensive chemotherapy. Decitabine will be given 20mg/m2 IV day 1-5, every 28 days. Avelumab will be given at 10mg/kg IV (initial dose) day 1, every 14 days. Using a standard 3x3 statistical design, protocol defined Dose Limiting Toxicities (DLT) will be assessed. In expansion stage, we will perform an expansion cohort of 9 additional patients using the Maximum Tolerated Dose (MTD) established in the Phase I portion.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Avelumab	* Decitabine 20mg/m2 IV day 1-5, every 28 days * Avelumab 10mg/kg IV, day 1, every 14 days

Timeline

• Start date: 2018-01-29
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2018-01-10
• Last updated: 2019-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study