search
Back to results

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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Decitabine 15 mg/m2 i.v.
Sponsored by
University Hospital Freiburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, Acute myeloid leukemia, Decitabine

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • other malignancy that is not in remission (previous chemotherapy for other malignancies is not an exclusion criteria)
  • cardiac insufficiency NYHA IV
  • HIV infection
  • other uncontrolled active infection
  • psychiatric disorder that interferes with treatment
  • known hypersensitivity to retinoids
  • contact lenses

Sites / Locations

  • Medizinische Hochschule Hannover
  • Klinikum der Technischen Universität Aachen
  • Universitätsklinikum Düsseldorf
  • Katholisches Krankenhaus Hagen
  • Klinikum Lüdenscheid
  • Universitätsklinikum Ulm
  • Klinikum Villingen-Schwenningen
  • Leyenburg Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

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

Outcomes

Primary Outcome Measures

response rate (complete and partial remissions, antileukemic effect)

Secondary Outcome Measures

overall survival
progression-free survival time
toxicity of Decitabine (alone and in combination with all-trans retinoic acid)

Full Information

First Posted
March 19, 2009
Last Updated
March 19, 2009
Sponsor
University Hospital Freiburg
search

1. Study Identification

Unique Protocol Identification Number
NCT00866073
Brief Title
Study of Low-Dose Intravenous Decitabine in Patients Aged > 60 Years With Acute Myeloid Leukemia
Official Title
Phase II Study of Low-Dose Intravenous Decitabine in Patients Aged > 60 Years With Acute Myeloid Leukemia Who Are Not Eligible for Standard Induction Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Freiburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Hypothesis: If after 4 courses of Decitabine none out of 12 patients achieves a response (complete or partial remission, antileukemic effect), the protocol will be stopped. If at least one response is seen among the first 12 patients, 17 additional patients will be treated in an open, uncontrolled manner. If in 3 or more of these 29 patients a response is achieved, this treatment will be considered effective and will be studied further, otherwise it will be considered ineffective. At a preliminary analysis after recruitment of 29 patients, encouraging results (response rate, tolerability) are prompting continuation of recruitment, with a planned inclusion of at least 60 patients, until initiation of the planned large, controlled phase II follow-up trial. Unexpected toxicities will be carefully evaluated. 29 patients were needed for the first two steps of this phase II study, at least 60 patients are planned for the extension of the recruitment. Expected study duration for the first two steps was 15-20 months, with 35-40 months total when including the third step.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML, Acute myeloid leukemia, Decitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Decitabine 15 mg/m2 i.v. - single arm
Intervention Type
Drug
Intervention Name(s)
Decitabine 15 mg/m2 i.v.
Other Intervention Name(s)
Dacogen
Intervention Description
Decitabine at 15 mg/m2 i.v. x 3 hours, three times daily on three consecutive days
Primary Outcome Measure Information:
Title
response rate (complete and partial remissions, antileukemic effect)
Time Frame
after four treatment courses of Decitabine, after 6 months
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
after 1 year
Title
progression-free survival time
Time Frame
after 1 year
Title
toxicity of Decitabine (alone and in combination with all-trans retinoic acid)
Time Frame
after 3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 other malignancy that is not in remission (previous chemotherapy for other malignancies is not an exclusion criteria) cardiac insufficiency NYHA IV HIV infection other uncontrolled active infection psychiatric disorder that interferes with treatment known hypersensitivity to retinoids contact lenses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lübbert, Prof Dr med
Organizational Affiliation
University Medical Center Freiburg - Dept. of Oncology/Hematoloy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Klinikum der Technischen Universität Aachen
City
Aachen
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
Katholisches Krankenhaus Hagen
City
Hagen
Country
Germany
Facility Name
Klinikum Lüdenscheid
City
Luedenscheid
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
Facility Name
Klinikum Villingen-Schwenningen
City
Villingen-Schwenningen
Country
Germany
Facility Name
Leyenburg Hospital
City
The Hague
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs