Venetoclax to Augment Epigenetic Modification and Chemotherapy

Acute Myeloid Leukemia, in Relapse Clinical Trial

Official title: A Phase I Study of Venetoclax to Augment Epigenetic Modification and Chemotherapy in Pediatric and Young Adult Patients With Relapsed and Refractory Acute Myeloid Leukemia

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The investigators are testing if the addition of venetoclax to epigenetic therapy will not only enhance the treatment response for patients with epigenetic lesions but improve the poor response we have observed in those patients without epigenetic lesions. The addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy will be investigated. This regimen may be tolerable and increase LSC targeting resulting in deeper, more durable responses in children, adolescents, and young adults with relapsed or refractory AML

The study will enroll patients in two strata - a primary stratum of eligible patients without Down syndrome, and a secondary stratum of eligible patients with Down syndrome (DS-AML). Subjects will receive two 35 day cycles of therapy. ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia Refractory
• Acute Myeloid Leukemia, in Relapse
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

• NCT number: NCT05317403
• Study type: Interventional
• Source: Medical College of Wisconsin
• Contact: Amberley Kemic, RN
• Phone: 414-266-2038
• Email: akemic@chw.org
• Status: Recruiting
• Phase: Phase 1
• Start date: March 31, 2023
• Completion date: January 2027