NCT00866073

Brief Summary

This study is an open-label phase II trial to investigate the efficacy and toxicity of low-dose decitabine (5-aza-2'-deoxycytidine) in elderly patients with acute myeloid leukemia (AML) not eligible for aggressive induction chemotherapy. AML patients above the age of 60 years (no upper age limit) who have not previously received and are not eligible for, standard induction treatment of their disease will be eligible for this trial. Decitabine will be administered as a 3 hour infusion at 15 mg/m2 three times daily on three consecutive days (total dose 135 mg/m2). In all patients with \> 20000 WBC/µl, this treatment will be repeated 1 week later. In patients with white blood cells exceeding 50 000/μl, decitabine treatment will be preceded by cytoreductive doses of hydroxyurea.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_2

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
Last Updated

March 20, 2009

Status Verified

March 1, 2009

Enrollment Period

5.8 years

First QC Date

March 19, 2009

Last Update Submit

March 19, 2009

Conditions

Acute Myeloid Leukemia

Keywords

AMLAcute myeloid leukemiaDecitabine

Outcome Measures

Primary Outcomes (1)

  • response rate (complete and partial remissions, antileukemic effect)

    after four treatment courses of Decitabine, after 6 months

Secondary Outcomes (3)

  • overall survival

    after 1 year

  • progression-free survival time

    after 1 year

  • toxicity of Decitabine (alone and in combination with all-trans retinoic acid)

    after 3-6 months

Study Arms (1)

A

EXPERIMENTAL

Decitabine 15 mg/m2 i.v. - single arm

Drug: Decitabine 15 mg/m2 i.v.

Interventions

Decitabine 15 mg/m2 i.v.DRUG

Decitabine at 15 mg/m2 i.v. x 3 hours, three times daily on three consecutive days

Also known as: Dacogen
A

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 60 years with acute myeloid leukemia (\> 30 % bone marrow blasts) not qualifying for, or not consenting to, standard induction chemotherapy or immediate allografting
  • life expectancy \> 3 months with successful treatment
  • performance status ECOG 0, 1, 2
  • age-adjusted normal cardiac, kidney, liver function (creatinine \< 1.5 mg/dl unless leukemia-related, total bilirubin \< 2.0 of upper normal limits)
  • patients with \>50 000 leukocytes/µl in whom initial cytoreduction according to protocol is effective
  • written informed consent

You may not qualify if:

  • AML of FAB subtype M3
  • previous induction-type chemotherapy for MDS or AML
  • previous treatment with Decitabine, 5-azacytidine or ATRA
  • "low-dose" chemotherapy (e.g.hydroxyurea, cytosine arabinoside, melphalan) within 8 weeks prior to Decitabine treatment, except for cytoreduction of leukocytosis \> 50 000/µl according to protocol - patients with \> 50 000 leukocytes/µl in whom initial cytoreduction according to protocol is ineffective
  • treatment with cytokines within previous 4 weeks
  • concomitant use of any other investigational drug
  • cardiac insufficiency NYHA IV
  • HIV infection
  • other uncontrolled active infection
  • psychiatric disorder that interferes with treatment
  • known hypersensitivity to retinoids
  • contact lenses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Klinikum der Technischen Universität Aachen

Aachen, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Katholisches Krankenhaus Hagen

Hagen, Germany

Location

Klinikum Lüdenscheid

Lüdenscheid, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Klinikum Villingen-Schwenningen

Villingen-Schwenningen, Germany

Location

Leyenburg Hospital

The Hague, Netherlands

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Michael Lübbert, Prof Dr med

    University Medical Center Freiburg - Dept. of Oncology/Hematoloy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 20, 2009

Study Start

April 1, 2003

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

March 20, 2009

Record last verified: 2009-03

Locations

DE(7)NL(1)