Open-Label Multicenter Trial of Glivec® (Imatinib Mesylate, Formerly Known as STI571) in Combination With Chemotherapy (MTC) in Patients With Refractory or Relapsed Acute Myeloid Leukemia (AML)
18 Years
N/A
Both
AML
Trial Information
Open-Label Multicenter Trial of Glivec® (Imatinib Mesylate, Formerly Known as STI571) in Combination With Chemotherapy (MTC) in Patients With Refractory or Relapsed Acute Myeloid Leukemia (AML)
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Safety Issue:
Yes
Principal Investigator
Lothar Bergmann, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital of Frankfurt, Medical Dept. II
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
AMLSG-R1
NCT ID:
NCT00744081
Start Date:
July 2004
Completion Date:
Related Keywords:
- AML
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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