AML
Conditions
Brief summary
The purpose of this study is to show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone.
Sponsors
Goethe University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Refractory AML after primary therapy * First relapse after a safe previous diagnosis of de novo or secondary AML * Age \> 18 years * Serum bilirubin \< 2.0 mg/dl * Serum creatinine \< 1.5 times the normal value or a creatinine clearance \> 60 ml/min * ECG and heart echography prior to start of therapy without severe findings * Overall condition \< 2 according to ECOG criteria * Life expectancy \> 6 weeks * Written informed consent by patients with full legal capacity
Exclusion criteria
* Serious secondary disease (clinically relevant cardiac disease, chronic- obstructive pulmonary disease, hepatic dysfunction, renal insufficiency) * Active secondary neoplasia (exception: adequately treated basalioma or epidermoid cancer and cervical carcinoma) * Known hypersensitivity to topoisomerase-I inhibitors * Overall condition \> 2 according to ECOG criteria * Pregnant/breast feeding women * Serious intercurrent infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone. | — |
Countries
Germany
Outcome results
None listed