Phase 3
N=45
Randomized Study of Decitabine in Maintenance Therapy of Acute Myeloid Leukemia (AML)
Acute Myelogenous Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00398983 ↗Enrolled (actual)
45
Serious AEs
2.2%
Results posted
Mar 2013
Primary outcome: Primary: Number of Participants With Relapse-Free Response at 1 Year — 10; 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Decitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Relapse-Free Response at 1 Year |
10; 10 | — |
Summary
The goal of this clinical study is to find out whether continued therapy with decitabine after achieving a remission in acute myeloid leukemia (AML) patients can help prolong the remission and prevent relapse of the disease.
Eligibility Criteria
Inclusion Criteria
- Adult patients (greater than 18 years) with acute myelogenous leukemia (AML) by World Health Organization (WHO) criteria (greater than 20% blasts) and unfavorable risk cytogenetics (including intermediate and poor risk categories) in first CR or complete remission without full platelet recovery (CRp)
- Adult patients (greater than 18 years) in second or subsequent Complete Response (CR) (or CRp)
- 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
- 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
- Performance status of 0, 1, or 2
- 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 aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) less than or equal to 3 times institutional upper limit of normal
Exclusion Criteria
- 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
- Known to be HIV+
- Active and uncontrolled disease/infection as judged by the treating physician
- Unable or unwilling to sign the consent form
- No other investigational therapy within the past 14 days
Data sourced from ClinicalTrials.gov (NCT00398983). 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.