Status:
COMPLETED
Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML)
Lead Sponsor:
Goethe University
Conditions:
AML
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00744081
Start Date
July 1 2004
End Date
December 1 2010
Last Update
March 10 2023
Active Locations (1)
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1
University of Frankfurt, Medical Dept. II
Frankfurt, Germany