Status:
COMPLETED
Gemtuzumab Ozogamicin in Combination With A-HAM in Refractory AML (GO-A-HAM)
Lead Sponsor:
University of Ulm
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 7-28
Detailed Description
Primary refractory AML is associated with an extremely poor prognosis \[1,2\]. In the AMLHD93 trial conducted by the AMLSG ULM, patients refractory to the first induction therapy with ICE (idarubicin,...
Eligibility Criteria
Inclusion
- Acute myeloid leukemia defined according the WHO classification not responding to first induction therapy
- Age 18-60 years
- Written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00143975
Start Date
June 1 2004
End Date
June 1 2009
Last Update
August 12 2010
Active Locations (27)
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1
Department of Hematology / Oncology, University Hospital of Innsbruck
Innsbruck, Austria, A-6020
2
St. Johann Hospital, Clinical Center of Salzburg
Salzburg, Austria, A-5020
3
Medical Department III, Hanusch-Hospital
Vienna, Austria, A-1140
4
Medical Department II, Central Hospital of Augsburg
Augsburg, Germany, 86156