Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)

Eisai

Status and phase: Completed; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Decitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00358644

DACO-017

Details and patient eligibility

About

The purpose of this study is to estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML).

Enrollment: 55 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Decitabine