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Genomic Predictors of Decitabine Response in AML/MDS


N/A
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

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Trial Information

Genomic Predictors of Decitabine Response in AML/MDS


Inclusion Criteria:



ONE OF THE FOLLOWING:

- Patient must have non-M3 AML and be >= 60 years of age OR

- Non-M3 AML with relapsed disease OR

- Symptomatic MDS with one of the following:

- Symptomatic anemia with either hemoglobin < 10.0 g/dL or requiring red blood cell
(RBC) transfusion

- Thrombocytopenia with a history of two or more platelet counts < 50,000/mcL or a
significant hemorrhage requiring platelet transfusions

- Neutropenia with two or more absolute neutrophil count (ANC) < 1,000/mcL

ALL OF THE FOLLOWING:

- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status =<
2

- Patient must have > 10% disease burden measured by cytomorphology, flow cytometry, or
cytogenetics

- Peripheral white blood cell count =< 50,000/mcl

- Total bilirubin =< 1.5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST)/alanine aminotransferase (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 Human Research Protections Office (HRPO) # 201011766
("Tissue Acquisition for Analysis of Genetic Progression Factors in Hematologic
Malignancies")

- Patient myst be >= 18 years of age

- Patient must be able to understand and willing to sign an Institutional Review Board
(IRB)-approved written informed consent document

Exclusion Criteria:

- Patient must not be pregnant or nursing

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Correlation of patient specific mutations with overall response rate

Outcome Description:

Best response after 4 treatment cycles as assessed according to International Working Group (IWG) criteria; bone marrow for gene sequencing will be collected at baseline; mutations will be correlated with overall response and their respective 95% confidence intervals will be provided.

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Welch John, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

201210102

NCT ID:

NCT01687400

Start Date:

February 2013

Completion Date:

January 2019

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Myelodysplastic Syndromes
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110