NCT06337331

Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant

A Phase II Trial of Venetoclax-Enhanced Reduced Intensity HLA-Mismatched Allogeneic Transplant for Ultra-High-Risk Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northside Hospital, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients eligible for a mismatch allogeneic stem cell transplant will receive Venetoclax daily for 7 days prior to transplant in addition to the following chemotherapy regimen: Decitabine daily for 5 days, Fludarabine daily for 5 days, and Busulfan daily for 2 days followed by 1 day of total body irradiation. Stem cell transplant will occur thereafter.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Venetoclax	400mg/day PO Days -8 to -2
DRUG	Decitabine	20mg/m2/day IV Days -7 to -3
DRUG	Fludarabine	30mg/m2/day IV Days -7 to -3
DRUG	Busulfan	3.2mg/kg/day IV Days -5 to -4
RADIATION	Total Body Irradiation	200cGy Day -2

Timeline

• Start date: 2024-08-31
• Primary completion: 2026-08-31
• Completion: 2027-08-31
• First posted: 2024-03-29
• Last updated: 2024-06-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study