Gemtuzumab Ozogamicin Before Allogeneic Stem Cell Transplantation (NCT00460447)
Prospective phase II trial with 30 patients in 1 site
- Option 1: Patient < 60 years of age with relapse after chemotherapy or > 12 months after hematopoetic stem cell transplantation gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories; an antibody-drug conjugate) 6 mg/ m² day –21 Mylotarg 3 mg/ m² day –14 Fludarabine (Fludara®; Genzyme, Inc. ) 30 mg/ m² day –6 to –3 TBI 2×2 Gy day –3 to –2 (total dose 8 Gy) tacrolimus (Protopic®; Astellas Pharma Inc.) (level adapted) from day –3 on mycophenolate Mofetil (CellCept®; Genentech, Inc.) 2 x 1000 mg p.o. from day 0 to day 40 PBSC day 0
- Option 2: Patient > 60 years of age or younger patients < 12 Months after hematopoetic stem cell transplantation Mylotarg 6 mg/ m² day –21 Mylotarg 3 mg/ m² day –14 Fludarabin 30 mg/ m² day –3 to –1 TBI 1×2 Gy day 0 (total dose 2 Gy) Tacrolimus (level adapted) from day –3 on Mycophenolat 2 x 1000 mg p.o. from day 0 to 40 PBSC day 0
This trial is sponsored by University Hospital Carl Gustav Carus. 
- Acute Myeloid Leukemia
- Allogeneic Transplantation
- Phase: I & II
- Estimated Enrollment: 30
- Start: October 2004
- Last verified: April 2007
Last Editorial review: July 23, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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