An Open-label Study of Lirilumab (BMS-986015) in Combination With 5-azacytidine (Vidaza) for the Treatment of Patients With Refractory/ Relapsed Acute Myeloid Leukemia | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02399917

An Open-label Study of Lirilumab (BMS-986015) in Combination With 5-azacytidine (Vidaza) for the Treatment of Patients With Refractory/ Relapsed Acute Myeloid Leukemia
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

The goal of this clinical research study is to find the highest tolerated dose of the combination of lirilumab and 5-azacytidine that can be given to patients with AML or high-risk MDS. Researchers also want to learn if the drug combination can help to control the disease. The safety of the drug combination will also be studied.

Status: 
Recruiting
Study Date: 
Wed, 04/01/2015 to Wed, 04/01/2020
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: 5-azacytidine Phase I Starting Dose: 75 mg/m2 a day by vein or subcutaneously on Days 1 - 7 of a 28 day cycle. Phase II Starting Dose: Maximum tolerated dose (MTD) from Phase I. Other Names: Azacitidine 5-aza Vidaza 5-AZC AZA-CR Ladakamycin NSC-102816 Azacytidine Drug: Lirilumab Phase I Starting Dose: 1.0 mg/kg by vein on Day 8 of a 28 day cycle. Phase II Starting Dose: Maximum tolerated dose (MTD) from Phase I. Behavioral: Phone Call If participant cannot come to the clinic, they will be called about 30 days after they go off study. This call will last about 5 minutes. If participant goes off study for reasons other than the disease getting worse, they will be called every 3-6 months for up to 5 years. Each call should last about 5 minutes.