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Clinical Trials/EUCTR2008-004583-40-DE
EUCTR2008-004583-40-DE
Active, not recruiting
Phase 1

A randomized, multi-center phase II trial to assess the efficay of 5-azacytidine added to standard primery therapy in elderly patients with newly diagnosed AML. - AML-AZA

niversitaetsklinikum Muenster0 sites234 target enrollmentJanuary 7, 2009
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ConditionsThe disease under investigation is newly diagnosed Acute Myeloid Leucemia (AML) in elderly patients.MedDRA version: 13.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DrugsVidaza (MA in USA and Switzerland)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
The disease under investigation is newly diagnosed Acute Myeloid Leucemia (AML) in elderly patients.
Sponsor
niversitaetsklinikum Muenster
Enrollment
234
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 7, 2009
End Date
December 8, 2012
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversitaetsklinikum Muenster

Eligibility Criteria

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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes

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 (leukocytes \> 100 000/µl) according to routine practice and entered into the study when leukocyte counts of 20,000/µl and below are reached. This applies only for the controlled part of the study.
  • •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 III° or IV°; 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 infiltration
  • •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 coagulopathy

Outcomes

Primary Outcomes

Not specified

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