Standard chemotherapy is capable of eliminating most leukemic blasts in acute myeloblastic leukemia (AML), while leukemia-initiating cells are not sufficiently eradicated. As a consequence, refractory disease and relapse frequently occur in AML, especially in elderly patients. The investigators propose that the addition of temsirolimus may improve standard AML chemotherapy. Furthermore, temsirolimus may specifically target the leukemia-initiating cells in AML, thereby reducing the risk of leukemia relapse. The study's main part is preceded by a open label run-in part, in which optimal temsirolimus dose and schedule for the main part o the study will be determined.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
33
intravenous application added to standard chemotherapy on up to 8 predefined days during the course of study treatment
intravenous application added to standard chemotherapy on up to 16 predefined days during the course of study treatment
Charité University Hospital Berlin, Campus Benjamin Franklin
Berlin, Germany
University Hospital Dresden
Dresden, Germany
University Hospital Erlangen
Erlangen, Germany
University Hospital Frankfurt
Frankfurt am Main, Germany
University Hospital Münster
Münster, Germany
median Event Free Survival (EFS)
Event Free Survival defined as time interval from day 1 of study treatment until treatment failure, relapse from complete remission (CR) or incomplete remission (CRi), or death from any cause, whichever occurs first.
Time frame: participants will be followed for one year after start of study treatment
event free survival probability
Event Free Survival defined as time interval from day 1 of study treatment until treatment failure, relapse from complete remission (CR) or incomplete remission (CRi), or death from any cause, whichever occurs first.
Time frame: participants will be followed for one year after start of study treatment
median Event Free Survival (EFS) of AML patients with different cytogenetic and molecular risk groups
Time frame: participants will be followed for one year after start of study treatment
rate of early response after the first induction cycle in the temsirolimus and the control group
Time frame: participants will be followed for one year after start of study treatment
rate of early response of AML patients with different cytogenetic and molecular risk groups
Time frame: participants will be followed for one year after start of study treatment
Complete Remission (CR) rate in the temsirolimus and the control group
Time frame: participants will be followed for one year after start of study treatment
CR rate of AML patients with different cytogenetic and molecular risk groups
Time frame: participants will be followed for one year after start of study treatment
Relapse Free Survival (RFS) of AML patients in the temsirolimus and the control group
Time frame: participants will be followed for one year after start of study treatment
Relapse Free Survival (RFS) of AML patients with different cytogenetic and molecular risk groups
Time frame: participants will be followed for one year after start of study treatment
Overall Survival (OS) of all AML patients in the temsirolimus and the control group
Time frame: participants will be followed for one year after start of study treatment
Overall Survival (OS) of AML patients with different cytogenetic and molecular risk groups
Time frame: participants will be followed for one year after start of study treatment
rate of molecular remissions in the temsirolimus and the control group
Time frame: participants will be followed for one year after start of study treatment
Number of adverse events in the temsirolimus and the control group
Time frame: participants will be followed for one year after start of study treatment
rate of molecular relapse after molecular remission of all AML patients in the temsirolimus and the control group after induction therapy and in the course of the first remission
Time frame: participants will be followed for one year after start of study treatment
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