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Study Summary
No. 2006-0358:.......Leukemia......Farhad Ravandi-Kashani......Leukemia
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Study Summary Title
Study Summary
Number:		2006-0358
Study Title:Randomized study of decitabine versus observation as maintenance therapy for adults with unfavorable risk AML in first CR or adults with relapsed AML in second or greater CR
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Physician New Patient Referral
Name:Farhad Ravandi-KashaniPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-7026
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase II/Phase IIIReturn
Visit:		every 3 to 6 months
Treatment
Agents:		DecitabineHome Care:After the first course, the study treatment may be given at home. Patients on
the observation arm of the study may receive treatment at the discretion of
their physician.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		No hospitalization
Description/
Intervention:		The goal of this clinical study is to find out whether continued therapy with
decitabine after achieving a remission in AML patients can help prolong the
remission and prevent relapse of the disease.
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Study Objectives / Outcomes
      Primary: To evaluate the benefit of maintenance therapy with decitabine in prolonging the duration of relapse-free survival as compared with the control patients.
      Secondary: To evaluate the benefit of maintenance therapy with decitabine in prolonging the duration of survival as compared with the control patients.
      Tertiary: To assess the toxicity of decitabine in this setting.
Quaternary: To assess the benefit of monitoring minimal residual disease using multi-parameter flow cytometry, WT-1 gene, and methylation studies
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Study Status Information
Study Activation / Registration Date:08/28/2006
IRB Review and Approval Date:06/21/2006
Study Type:Phase Iii
Recruitment Status:Closed
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Adult patients (greater than 18 years) with AML by WHO criteria and unfavorable risk cytogenetics (including intermediate and poor risk categories) in first CR or CRp

2) Adult patients (greater than 18 years) in second or subsequent CR (or CRp)

3) Patients in first CR (or CRp) may have received any induction chemotherapy regimen; they may have received post-remission consolidation therapy (except for transplant) prior to inclusion in this protocol

4) Patients in 2nd or subsequent CR (or CRp) may have received any appropriate salvage regimen before achieving CR and may have received further therapy before inclusion

5) Performance status of 0, 1, or 2

6) Adequate organ function with creatinine less than or equal to 2.0 mg/dL, bilirubin less than or equal to 3.5 mg/dL and ALT and AST less than or equal to 3 times institutional upper limit of normal
Exclusion Criteria:1) Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization

2) Known to be HIV+

3) Active and uncontrolled disease/infection as judged by the treating physician

4) Unable or unwilling to sign the consent form

5) No other investigational therapy within the past 14 days
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Links
Registration Number: NCT00398983
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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