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A Phase II Study of Decitabine For the Front-line Treatment of Older Patients With Acute Myeloid Leukemia


Phase 2
60 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia

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Trial Information

A Phase II Study of Decitabine For the Front-line Treatment of Older Patients With Acute Myeloid Leukemia


Inclusion Criteria:



1. A diagnosis of AML or transformed from myelodysplastic syndrome (MDS) within 2 weeks
of study enrollment.

2. Ineligible to receive intensive chemotherapy for their disease.

3. Have not received any chemotherapy within 4 weeks of study enrollment and must have
recovered from any treatment-related toxicities.

Exclusion Criteria:

1. Received previous treatment for AML.

2. Previously received Vidaza.

3. Received any other investigational agents within 30 days of first dose of study drug.

4. Uncontrolled intercurrent illness.

5. Had radiotherapy within 14 days prior to study enrollment.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete Response = Morphologic Complete Remission (mCR)

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Eisai US Medical Services

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

DACO-017

NCT ID:

NCT00358644

Start Date:

March 2005

Completion Date:

December 2008

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia
  • AML
  • Decitabine
  • Dacogen
  • MGI PHARMA, INC.
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Fountain Valley, California  92708
Columbia, Missouri  65203