Phase II Study on Gemtuzumab Ozogamicin in Combination with All-trans-Retinoic Acid, high-dose Cytarabine and Mitoxantrone in Patients with primary refractory acute myeloid leukemia [GO-A-HAM] - GO-A-HAM
- Conditions
- primary refractory patients with acute myeloid leukemia
- Registration Number
- EUCTR2004-003739-30-AT
- Lead Sponsor
- niversitätsklinikum Ulm / University Clinical Center Ulm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 84
1.) acute myeloid leukemia defined according the WHO classification not responding to first induction therapy
2.) age 18-60 years
3.) written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
1.) acute promyelocytic leukemia
2.) uncontrolled infection
3.) transfusion-refractory thrombocytopenia
4.) pregnancy, breast-feeding, insufficient contraception
5.) participation in other controlled clinical trials
6.) organ insufficiency: kidneys, liver, lungs, heart
7.) severe neurological or psychiatrical condition interfering with informed consent
8.) No consent for the registration, storage and processing of data concerning the characteristics of the AML and the individual course
9.) performance status > grad 2 according the WHO classification
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method