Phase 2 N=55 Treatment

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

Acute Myeloid Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00358644 ↗

Enrolled (actual)

Serious AEs

72.7%

Results posted

Sep 2009

Primary outcome: Primary: Complete Response = Morphologic Complete Remission (mCR) — 13 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Decitabine (Drug)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Eisai Inc.
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Complete Response = Morphologic Complete Remission (mCR)	13	—

Summary

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).

Eligibility Criteria

Inclusion Criteria

A diagnosis of AML or transformed from myelodysplastic syndrome (MDS) within 2 weeks of study enrollment.
Ineligible to receive intensive chemotherapy for their disease.
Have not received any chemotherapy within 4 weeks of study enrollment and must have recovered from any treatment-related toxicities.

Exclusion Criteria

Received previous treatment for AML.
Previously received Vidaza.
Received any other investigational agents within 30 days of first dose of study drug.
Uncontrolled intercurrent illness.
Had radiotherapy within 14 days prior to study enrollment.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00358644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.