Study Title
Allogenic Stem Cell Transplantation in Patients With High Risk CD33+ AML/MDS/JMML (NCT00669890)
Trial Description
The addition of gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories) in combination with busulfan (Myleran®; GlaxoSmithKline LLC)/ cyclophosphamide (Cytoxan® ;Bristol-Myers Squibb Company) 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 (MTD) of the immune therapy (gemtuzumab ozogamicin) when given in combination with the myeloablative (high dose) drugs used in this study for allogeneic stem cell transplant (ASCT)
This trial is sponsored by New York Medical College. [1]
Study Data
- Condition:
- Acute Myeloid Leukemia
- Juvenile Myelomonocytic Leukemia
- Myelodysplastic Syndrome
- Interventions:
- Drugs used in this trial
- gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories)
- busulfan (Myleran®; GlaxoSmithKline LLC)
- cyclophosphamide (Cytoxan® ;Bristol-Myers Squibb Company)
- thymoglobulin (ATG/ATGAM)
- tacrolimus (Protopic®; Astellas Pharma Inc.)
- Mycophenolate Mofetil (CellCept®; Genentech, Inc.)
- methotrexate (Trexall®; Teva Pharmaceuticals)
- Drugs used in this trial
- Phase: I
- Enrollment: 12
- Start: May 2004
- Completion: December 2013
- Last verified: April 2015
Study Schematic
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Last Editorial review: July 21, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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