Gemtuzumab Ozogamicin Before Allogeneic Stem Cell Transplantation

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Carl Gustav Carus
• Treatments: Gemtuzumab

Criteria

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)