Status:
UNKNOWN
Gemtuzumab Ozogamicin Before Allogeneic Stem Cell Transplantation
Lead Sponsor:
University Hospital Carl Gustav Carus
Conditions:
Acute Myeloid Leukemia
Allogeneic Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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 ce...
Detailed Description
Scientific/Medical Rationale (Objective): Primary: documentation of the extramedullary toxicity of the standard therapy Secondary: Induction of a persistent remission by the combination of Mylotar...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00460447
Start Date
October 1 2004
Last Update
April 16 2007
Active Locations (1)
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1
Medizinische Klinik und Poliklinik I
Dresden, Germany, 01307