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A Double-blind, Placebo-controlled, Randomized, Multicenter Phase II Trial to Assess the Efficacy of Temsirolimus Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML

Phase 2
61 Years
Open (Enrolling)
Acute Myeloblastic Leukemia

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Trial Information

A Double-blind, Placebo-controlled, Randomized, Multicenter Phase II Trial to Assess the Efficacy of Temsirolimus Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML

Inclusion Criteria:

- Newly diagnosed AML (except APL) according to the FAB classification, including AML
evolving from MDS or other hematological diseases and AML after previous cytotoxic
therapy or radiation (secondary AML)

- Bone marrow aspirate or biopsy contains ≥ 20% blasts of all nucleated cells or
differential blood count must contain ≥ 20% blasts. In AML FAB M6 ≥ 30% of
non-erythroid cells in the bone marrow must be leukemic blasts. In AML defined by
cytogenetic aberrations the proportion of blasts may be < 20%.

- Age ≥ 61 years

- Informed consent, personally signed and dated to participate in the study

- Willingness of male patients whose sexual partners are women of child-bearing
potential (WOCBP), to use an effective form of contraception (pearl index < 1%)
during the study and at least 6 months thereafter.

Exclusion Criteria:

- Patients who are not eligible for standard chemotherapy

- Previous treatment for AML, except leukapheresis for patients with hyperleukocytosis
(leukocytes > 100,000/µl and / or leukostatic syndrome) or hydroxyurea

- Known central nervous system manifestation of AML

- Cardiac Disease: Heart failure NYHA III° or IV°; active coronary artery disease (MI
more than 6 months prior to study entry is permitted); serious cardiac ventricular
arrhythmias, defined as: ventricular extrasystoles grade LOWN IV, sustained or
non-sustained ventricular tachycardias, and history of ventricular fibrillation /
ventricular flutter, unless patient is protected by an internal cardioverter /
defibrillator or ventricular arrhythmia was attributable to a myocardial ischemia > 6
months before study entry.

- Chronically impaired renal function (creatinine clearance < 30 ml / min)

- Chronic pulmonary disease with relevant hypoxia

- Inadequate liver function (ALT and AST ≥ 2.5 x ULN) if not caused by leukemic

- Total bilirubin ≥ 1.2 mg/dL if not caused by leukemic infiltration

- Uncontrolled active infection

- Concurrent malignancies other than AML with an estimated life expectancy of less than
two years and requiring therapy

- Known HIV and/or hepatitis C infection

- Evidence or history of CNS disease, including primary or metastatic brain tumors,
seizure disorders

- History of organ allograft

- Concomitant treatment with kinase inhibitors, angiogenesis inhibitors, calcineurin
inhibitors and Mylotarg

- Serious, non-healing wound, ulcer or bone fracture

- Allergy to study medication or excipients in study medication

- Investigational drug therapy outside of this trial during or within 4 weeks of study

- Any severe concomitant condition which makes it undesirable for the patient to
participate in the study or which could jeopardise compliance with the protocol

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

median Event Free Survival (EFS)

Outcome Description:

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.

Outcome Time Frame:

participants will be followed for one year after start of study treatment

Safety Issue:


Principal Investigator

Christian Brandts, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johann Wolfgang Goethe University Hospital


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

May 2012

Completion Date:

September 2016

Related Keywords:

  • Acute Myeloblastic Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid