Overview

Gemtuzumab Ozogamicin in Combination With A-HAM in Refractory AML (GO-A-HAM)

Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
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 7-28
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Ulm
Treatments:
Cytarabine
Gemtuzumab
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