Gemtuzumab Ozogamicin Before Allogeneic Stem Cell Transplantation
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Study Design:
prospective phase II trial with 30 patients in 1 site
Treatment Scheme:
Option 1: Patient < 60 years of age with relapse after chemotherapy or > 12 months after
hematopoetic stem cell transplantation Mylotarg 6 mg/ m² day -21 Mylotarg 3 mg/ m² day -14
Fludarabin 30 mg/ m² day -6 to -3 TBI 2x2 Gy day -3 to -2 (total dose 8 Gy) Tacrolimus (level
adapted) from day -3 on Mycophenolat 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 1x2 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