Gemtuzumab Ozogamicin Before Allogeneic Stem Cell Transplantation

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

Sex

All

Minimum age

18 Years

Maximum age

70 Years

Inclusion Criteria:

* \- patients with acute myelotic leukemia and expression of CD33 on \> 5% of blasts in bone marrow
* relapse after chemotherapy
* relapse after autologous or allogenic hematopoetic stem cell transplantation
* pts. in 2nd remission after chemotherapy and ineligible for a conventional allogeneic transplantation
* age: 18-70 years
* informed consent of the patient
* ASAT/ ALAT \< 3fold of upper standard
* Bilirubin \< 2fold of upper standard
* ejection fraction \> 40% in echocardiography
* potential donor in accordance with the following priorities:
* 1st HLA-identical related donor (HLA \*A, \*B, \*C and \*DR)
* 2nd HLA-identical non-related donor with the maximum of 1 allelmismatch (DNA typing A, B, C, DRB1, DQB1)