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Study of Low-Dose Intravenous Decitabine in Patients Aged > 60 Years With Acute Myeloid Leukemia

NCT00866073 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2009-03-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Decitabine 15 mg/m2 i.v.

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

Sponsors & Collaborators

  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Michael Lübbert, Prof Dr med · University Medical Center Freiburg - Dept. of Oncology/Hematoloy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2009-02-28
Completion
2009-03-31

Countries

  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00866073 on ClinicalTrials.gov