Overview
Gemtuzumab Ozogamicin in Combination With A-HAM in Refractory AML (GO-A-HAM)
Status:
Completed
Completed
Trial end date:
2009-06-01
2009-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
GO-A-HAM: Gemtuzumab Ozogamicin 3g/m² day 1 Cytarabine 3g/m² bid days 1-3 Mitoxantrone 12mg/m² days 2,3 All-trans Retinoic acid 45mg/m² days 4-6 and 15 mg/m² days 7-28Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of UlmTreatments:
CytarabineGemtuzumab
Mitoxantrone
Criteria
Inclusion Criteria:- Acute myeloid leukemia defined according the WHO classification not responding to
first induction therapy
- Age 18-60 years
- Written informed consent
Exclusion Criteria:
- Acute promyelocytic leukemia
- Uncontrolled infection
- Transfusion-refractory thrombocytopenia
- Pregnancy, breast-feeding, insufficient contraception
- Organ insufficiency: kidneys, liver, lungs, heart
- Severe neurological and psychiatrical interfering with informed consent
- No consent for the registration, storage and processing of data concerning the
characteristics of the AML and the individual course
- Performance status > grad 2 according the WHO classification