NCT03338348 - Study of Vosaroxin With Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 19, 2018

Primary Completion Date

October 31, 2019

Study Completion Date

October 31, 2019

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndrome With Excess Blasts-2 (MDS-EB-2)

Interventions

DRUG

Vosaroxin

Cycle 1-8: Dose Level 0: 70mg/m², Dose Level -1: 50mg/m², Dose Level -2: 40mg/m², IV over ten minutes, d 1+4 .

DRUG

Azacitidine

"Cycle 1-8 Azacitidine: 75 mg/m²/d subcutaneously, d 1-7;~Maintenance with single agent azacitidine at 75 mg/m²/d on days 1-7 until relapse or progression."

Trial Locations (3)

26133

Klinikum Oldenburg, Klinik für Innere Medizin II, Oldenburg

45239

Kliniken Essen-Süd, Evang. Krankenhaus Essen-Werden gGmbH, Essen

89081

University Hospital Ulm, Ulm