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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. ;


Study Design


Related Conditions & MeSH terms


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

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