Venetoclax, Azacitidine, and Lintuzumab-Ac225 in AML Patients

PHASE1/PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 31, 2023

Primary Completion Date

December 31, 2023

Study Completion Date

September 30, 2024

Conditions
Acute Myeloid LeukemiaRelapsed Adult AML
Interventions
BIOLOGICAL

Lintuzumab-Ac225

In the Phase I, patients will be enrolled into the following dose escalation cohorts: 0.50 μCi/kg, 1.0 μCi/kg, and 1.5 μCi/kg. If the 0.50 μCi/kg dose is determined to exceed the MTD, a 0.25 μCi/kg dose will be explored.

DRUG

Venetoclax

400 mg daily will be taken orally on Days 1-21 of a 28-day cycle. There will be a ramp up of venetoclax dosing in the first cycle, with 100 mg administered on Day 1, 200 mg on Day 2, and 400 mg on Day 3 and Day 4 and later. Patients on antifungal azoles should receive one-half these doses, up to a maximum of 200 mg of venetoclax.

DRUG

Azacitidine

75 mg/m2 will be administered on days 1-7 of a 28-day cycle.

Sponsors
All Listed Sponsors
lead

Actinium Pharmaceuticals

INDUSTRY