drugset
drugset / Trial / NCT05317403

Venetoclax to Augment Epigenetic Modification and Chemotherapy

NCT05317403 ↗

Phase 1 Recruiting 40 enrolled Medical College of Wisconsin
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The investigator is testing the addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy to enhance treatment response in AML patients.

Timeline

Start
2023-03-31
Primary completion
2027-01
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Venetoclax Small molecule 120 mg/m2 Oral
Subject Venetoclax Small molecule 240 mg/m2 Oral
Subject Venetoclax Small molecule 360 mg/m2 Oral
Background Azacitidine Other / unclassified 75 mg/m2 Intravenous
Background Cytarabine Small molecule 30 mg Intravenous
Background Cytarabine Small molecule 50 mg Intravenous
Background Cytarabine Small molecule 70 mg Intravenous
Background Cytarabine Small molecule 2000 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background Vorinostat Small molecule 180 mg/m2 Oral
Background Vorinostat Small molecule 200 mg Oral
Background filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous

Indications

acute myeloid leukemia