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A Randomized, Multi-center Phase II Trial to Assess the Efficacy of 5-azacytidine Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML

Phase 2
61 Years
Not Enrolling
Acute Myeloid Leukemia

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Trial Information

A Randomized, Multi-center Phase II Trial to Assess the Efficacy of 5-azacytidine Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML

Inclusion Criteria:

- Patients with newly diagnosed AML (except APL) according to the FAB or WHO
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 must contain ≥ 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

- Male patients enrolled in this trial must use adequate barrier birth control measures
during the course of the 5-azacytidine treatment and for at least 3 months after the
last administration of 5-azacytidine.

Exclusion Criteria:

- Patients who are not eligible for standard chemotherapy as described in chapter 5.2
and 5.3

- Hyperleukocytosis (leukocytes > 20,000/µl) at study entry. These patients should be
treated with hydroxyurea or receive leukocytapheresis treatment (if leukocytes >
100,000/µl) according to routine practice and entered into the study when leukocyte
counts below 20,000/µl are reached. This applies only for the controlled part of the

- Patients with initial hyperleukocytosis above 20,000/µl can only be enrolled into the
controlled part of the study, but not in the run-in dose finding part.

- Known central nervous system manifestation of AML

- Cardiac Disease: Heart failure NYHA class 3 or 4; unstable coronary artery disease
(MI more than 6 months prior to study entry is permitted); serious cardiac
ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin
are permitted)

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

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

- Total bilirubin ≥ 1.5 x ULN if not caused by leukemic infiltration

- Known HIV and/or hepatitis C infection

- Evidence or history of severe non-leukemia associated bleeding diathesis or

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

- Uncontrolled active infection

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

- History of organ allograft

- Hypersensitivity to cytarabine (not including drug fever or exanthema), daunorubicin,
azacytidine or mannitol

- Previous treatment of AML except hydroxyurea and up to 2 days of ≤100 mg/m2/d

- Previous therapy with 5-azacytidine (i.e. for an antecedent myelodysplastic syndrome)

- Patients with investigational drug therapy outside of this trial during or within 4
weeks of study entry should be discussed with the study office whether study
participation is possible

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median Event Free Survival (EFS) of all AML patients

Outcome Time Frame:

continously up to 12 months after start of study

Safety Issue:


Principal Investigator

Carsten Müller-Tidow, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitätsklinikum Münster, Medizinische Klinik A


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

July 2009

Completion Date:

December 2012

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia
  • azacitidine
  • elderly
  • demethylating agent
  • flt3
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid