NCT02117297

SCT Plus Immune Therapy in Average Risk AML/MDS

Allogeneic Stem Cell Transplantation Following by Targeted Immune Therapy) (Gemtuzumab Ozogamicin) in Average Risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome (AML/MDS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: New York Medical College · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.

Detailed description

Reduced intensity conditioning regimen of Busulfan (Bu) and Fludarabine (Flu) + Anti-Thymocyte Globulin (ATG ) (unrelated donors only) or reduced toxicity conditioning regimen of Bu/Flu/alemtuzumab, or reduced hepatic toxicity regimen of melphan/Flu/alemtuzumab and AlloSCT, followed by Gemtuzumab Ozogamicin consolidation in patients with average risk AML/MDS meeting eligibility criteria.

Conditions

• Acute Myelogenous Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Gemtuzumab Ozogamicin	Gemtuzumab, 9.0 mg/m2, will be given IV over 2 hours two times post allogeneic transplantation.

Timeline

• Start date: 2012-01-12
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2014-04-17
• Last updated: 2023-10-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study