Status:
COMPLETED
Trial of Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Lead Sponsor:
Eisai Inc.
Conditions:
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to provide decitabine to patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have completed participation per protocol in the DACO-018 study.
Detailed Description
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, ...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Must be age 18 years or older.
- Must have completed participation per protocol in the MGI PHARMA DACO-018 decitabine trial.
- Must enroll in this trial no more than 8 weeks after discontinuation from the MGI PHARMA DACO-018 trial.
- Must have recovered from all toxic effects of all prior therapy.
Exclusion
- Must not have any other active malignancy, other than basal or squamous cell skin carcinoma.
- 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.
- 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.
- Must not be pregnant or lactating.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00760084
Start Date
July 1 2005
End Date
February 1 2008
Last Update
August 8 2011
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110