Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML)
Phase 2
Completed
- Conditions
- AML
- Registration Number
- NCT00744081
- Lead Sponsor
- Goethe University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Frankfurt, Medical Dept. II
🇩🇪Frankfurt, Germany