Pracinostat and Gemtuzumab Ozogamicin (PraGO) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

May 24, 2019

Primary Completion Date

May 5, 2021

Study Completion Date

May 5, 2021

Conditions
Relapsed Adult AML
Interventions
DRUG

Gemtuzumab Ozogamicin 3 mg/m^2

"GO 3 mg/m\^2 on Day 1, 4, and 7~Maintenance: 2mg/m2 intravenous administration on day 1, in a 28-day cycle."

DRUG

Gemtuzumab Ozogamicin 2 mg/m^2

GO 2 mg/m\^2 on Day 1 of a 28-day cycle.

DRUG

Pracinostat - 45 mg

Induction: 45mg administered orally 3 days a week with 48 hours between dosing (e.g., Monday, Wednesday, and Friday) for three consecutive weeks, followed by 1 week of rest, in 28-day cycles.

DRUG

Pracinostat - 60 mg

Escalation: 60 mg administered orally three days a week with 48 hours between dosing (e.g., Monday, Wednesday, and Friday) for three consecutive weeks, followed by one week of rest, in 28-day cycles.

Trial Locations (1)

53226

Froedtert Hospital & the Medical College of Wisconsin, Milwaukee

All Listed Sponsors
lead

Medical College of Wisconsin

OTHER

NCT03848754 - Pracinostat and Gemtuzumab Ozogamicin (PraGO) in Patients With Relapsed/Refractory Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter