NCT00669890

Allogenic Stem Cell Transplantation in Patients With High Risk CD33+ AML/MDS/JMML

Gemtuzumab Ozogamicin in Combination With Busulfan and Cyclophosphamid and Allogenic Stem Cell Transplantation in Patients With High Risk CD33+ Acute Myelogenous Leukemia/Myelodysplastic Syndrome/Juvenile Myelomonocytic Leukemia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: New York Medical College · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The addition of gemtuzumab ozogamicin (GO) in combination with Busulfan/Cyclophosphamide followed by AlloSCT in patients with high risk CD33+ AML/JMML/MDS will be safe and well tolerated. This study will attempt to determine the maximum tolerated dose of the immune therapy (gemtuzumab) when given in combination with the myeloablative (high dose) drugs used in this study for allogeneic stem cell transplant. (Part A)

Detailed description

Gemtuzumab Ozogamicin (CMA-676) is a chemotherapeutic agent consisting of recombinant humanized anti-CD33 antibody conjugated with calicheamicin, a highly potent cytotoxic antitumor antibiotic. The antibody portion of Gemtuzumab binds specifically to the CD33 antigen, a sialic acid-dependent adhesion protein expressed on the surface of leukemia blasts, normal and leukemic myeloid colony-forming cells, including leukemic clonogenic precursors, but excluding pluripotent hematopoietic stem cells and nonhematopoietic cells. This results in formation of the complex that is internalized, upon which calicheamicin derivative is released with in the lysosomes of the myeloid cell. The free calicheamicin derivative then binds to the DNA, resulting in DNA double strand breaks and consequential cell death.

Conditions

• Acute Myeloid Leukemia
• Juvenile Myelomonocytic Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Gemtuzumab Ozogamicin	Dose Escalation
DRUG	Busulfan	Conditioning Regimen
DRUG	Cyclophosphamide	Conditioning Regimen
DRUG	Thymoglobulin	(Unrelated Donors only)
DRUG	Tacrolimus	GVHD Prophylaxis
DRUG	Mycophenolate Mofetil	GVHD Prophylaxis
DRUG	Methotrexate	GVHD Prophylaxis

Timeline

• Start date: 2004-05-01
• Primary completion: 2012-12-01
• Completion: 2013-12-01
• First posted: 2008-05-01
• Last updated: 2015-04-22

Locations

1 site across 1 country: United States