NCT05456269 - A Study of Bisantrene Combined With Cytarabine or With Decitabine for Adult Subjects With Extramedullary AML and MDS | Biotech Hunter

Timeline

Start Date

July 29, 2022

Primary Completion Date

August 31, 2023

Study Completion Date

August 31, 2023

Conditions

Acute Myeloid LeukemiaRecurrent Acute Myeloid LeukemiaRefractory Acute Myeloid LeukemiaHigher Risk Myelodysplastic SyndromeChronic Myelomonocytic Leukemia

Interventions

DRUG

Bisantrene Dihydrochloride (high dose)

Induction monotherapy cycle: IV bisantrene daily on Days 1 to 7, starting at 250 mg/m2 then adjusted to either 275 mg/m2 or 225 mg/m2 based on confirmed dose (Run-in) Consolidation combination cycle/s: IV bisantrene daily on Days 1 to 2

DRUG

Bisantrene Dihydrochloride (low dose)

IV bisantrene at escalating doses for 3 dose levels of 50, 65, 85 mg/m2 on Days 3 and 5 until Maximum tolerated dose (MTD) reached.

DRUG

Cytarabine Hydrochloride

Consolidation cycles: continuous IV cytarabine (100mg/m2) on Days 1 to 5

DRUG

Decitabine and cedazuridine

PO fixed-dose decitabine/cedazuridine 35/100 mg tablet daily for 5 days (Days 1 to 5), 1 hour prior bisantrene infusion

Trial Locations (1)

2298

Calvary Mater, Newcastle