Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase II Study of Decitabine For the Front-line Treatment of Older Patients With Acute Myeloid Leukemia
Verified date | June 2010 |
Source | Eisai Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 55 |
Est. completion date | December 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Eisai Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Response = Morphologic Complete Remission (mCR) | 1 year | No |
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