Phase 2
Completed N=114
Genomic Predictors of Decitabine Response in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
Leukemia, Myeloid, Acute · Myelodysplastic Syndromes
Source: ClinicalTrials.gov NCT01687400 ↗
Enrolled (actual)
114
Serious AEs
78.1%
Results posted
Oct 2018
Primary outcomePrimary: Correlation of Patient Specific Mutations With Overall Response Rate — 26; 3; 9; 2 Participants — p=0.035
Summary
This clinical trial studies potential genetic markers which might be used to predict which patients with acute myeloid leukemia or myelodysplastic syndromes respond to decitabine. This study will contribute to the efforts to find effective and less toxic therapies to provide durable remissions in a significant proportion of elderly AML patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation of Patient Specific Mutations With Overall Response Rate |
26; 3; 9; 2; 7; 5 | 0.035 sig |
| SECONDARY Compare Outcomes of a 10-day Decitabine Per Cycle Regimen to a 5-day Regimen (Historical Controls) |
74.42; 63.95 | <0.0001 sig |
| SECONDARY Rate of Mutation Clearance During Treatment |
-0.781; -0.2214; -0.2122; -0.08344; -0.2641; -0.07478 | — |
| SECONDARY Peripheral Blood Decitabine Plasma Levels |
140.5; 117.2; 67.71; 145; 298.5; 99.64 | — |
| SECONDARY Change in Bone Marrow Methylcytosine |
0.53; 0.5374; 0.4416; 0.4639 | — |
Eligibility Criteria
Inclusion Criteria
All of the following:
- Patient must have non-M3 AML or MDS
- An adverse risk karyotype defined by:
- Complex karyotype by cytogenetics, or
- Deletion of all or part of chromosome 5, 7, 12, or 17 defined by FISH or cytogenetics, or
- Somatic TP53 mutation
All of the following:
- Patient must have an ECOG performance status ≤ 2.
- Patient must have >10% disease burden measured by cytomorphology, flow cytometry, or cytogenetics.
- Patient must have peripheral white blood cell count 18 years of age.
- Patient must be able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion Criteria
- Patient must not be pregnant or nursing
- Patient must not have acute promyelocytic leukemia or t(15;17) observed by FISH.
- Patient must not have known central nervous system (CNS) leukemia
- Patient must not have a history of positive human immunodeficiency virus (HIV) serology
- Patient must not have a history of positive hepatitis C serology
- Patient must not have undergone prior allogeneic stem cell transplant
- Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, ongoing or active graft-versus-host disease (GVHD), congestive heart failure of New York Heart Association (NYHA) class 3 or 4, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
- Patient must not have had radiation therapy within 14 days of enrollment
- Patient must not have received any chemotherapy within 21 days of enrollment and any acute treatment-related toxicities must have returned to baseline. Patients may be receiving hydrea at time of enrollment.
Data sourced from ClinicalTrials.gov (NCT01687400). 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. Informational only — not medical advice.