Genomic Predictors of Decitabine Response in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

Completed · Phase 2

Conditions studied: Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

In brief

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.

Key facts

Study ID: NCT01687400
Run by: Washington University School of Medicine
People needed: 114
Starts: 2013-02-12
Expected to finish: 2017-11-13
Last updated by the study team: 2018-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 < 50,000/mcl.
Patient must have adequate organ function, defined as:
Total bilirubin < 1.5 x ULN
AST/ALT < 2.5 x ULN
Serum creatinine < 2.0 x ULN
Patient must have undergone ≤ 2 cycles of prior hypomethylating agent (decitabine or azacitidine).
Patient must be enrolled in HRPO# 201011766 ("Tissue Acquisition for Analysis of Genetic Progression Factors in Hematologic Diseases").
Patient must be > 18 years of age.
Patient must be able to understand and willing to sign an IRB-approved written informed consent document.

You may not qualify if…

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.

Where it is running

Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.