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An Expanded Access Protocol to Administer Decitabine to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome


Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia, Myelodysplastic Syndrome

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Trial Information

An Expanded Access Protocol to Administer Decitabine to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome


The objectives of this trial are:

- To generate additional information about the overall safety profile,

- To generate safety information of hepatically or renally impaired patients, as
appropriate, and

- To generate safety information when patients are also taking concomitant medications
and/or therapies without trial restrictions when decitabine is administered at a dose
of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks in
patients with MDS or AML (≥ 30% blasts).

The purpose of this open-label, expanded-access trial is to provide decitabine to patients
with AML or MDS who have completed participation per protocol in the DACO-018 study and for
whom continuation of treatment with decitabine is indicated, per the opinion of the
investigator. In order to continue treatment with decitabine, at a minimum, there must be
no disease progression while the patient was participating in the DACO-018 trial and during
the period after the patient discontinued from the DACO-018 study and before entering this
trial. Patients must enroll in this trial within 8 weeks of discontinuing from the DACO-018
study and not have received any other chemotherapy for their disease during this interim
period.

Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for
5 consecutive days every 4 weeks.


Inclusion Criteria:



1. Must sign an Institutional Review Board (IRB) -approved informed consent form,
indicating his/her awareness of the investigational nature of decitabine and its
potential hazards prior to initiation of any study-specific procedures or treatment.

2. Must have had one of the following:

MDS (de novo or secondary) fitting any of the recognized French-American-British
classifications

OR

chronic myelomonocytic leukemia (with WBC <12,000/μL)

AND

an International Prognostic Scoring System score of ≥1.5 as determined by complete
blood count, bone marrow assessment and bone marrow cytogenetics within 30 days of
study entry OR AML (≥ 30 % bone marrow blasts), except M3 or acute promyelocytic
leukemia.

3. Must be age 18 years or older.

4. Must have completed participation per protocol in the MGI PHARMA DACO-018 decitabine
trial.

5. Must enroll in this trial no more than 8 weeks after discontinuation from the MGI
PHARMA DACO-018 trial.

6. Must have recovered from all toxic effects of all prior therapy.

Exclusion Criteria:

1. Must not have any other active malignancy, other than basal or squamous cell skin
carcinoma.

2. Must not have received in the period after discontinuation from DACO-018 and
enrollment into this trial any other chemotherapy agent, including investigational
agents, for their disease.

3. Must not have evidence of any other significant clinical disorder or laboratory
finding that makes it undesirable for the patient to participate in the trial, at the
discretion of the principal investigator.

4. Must not be pregnant or lactating.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The Number of Subjects With Adverse Events

Outcome Description:

Generate safety information when patients were also taking concomitant medications and/or therapies without trial restrictions when decitabine was administered at a dose of 20 milligrams per meter squared (mg/m^2) over a 1-hour intravenous (IV) infusion for 5 consecutive days every 4 weeks in patients with MDS (< 30% blasts) or AML (> 30% blasts).

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Akhil Baranwal, MD

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

DACO-021

NCT ID:

NCT00760084

Start Date:

July 2005

Completion Date:

February 2008

Related Keywords:

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Dacogen
  • Decitabine
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110