Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT02204020
Eligibility Criteria:
Inclusion Criteria:
* Age≥18 with MDS or high-risk AML, morphologically confirmed and based on World Health Organization criteria (see below for definition of high-risk AML)\*, who are transplant candidates with an available human leukocyte antigen (HLA) -matched sibling or unrelated donor with at least 8/8 match
\*Definition of high-risk AML:
* Age≥60 years
* Age\<60 years with any of the following:
* Secondary AML
* Poor risk cytogenetics, which include abnormalities of chromosome 3, 5, or 7, trisomy 8, 11q23 abnormalities, t(6;9), 20q-, and complex karyotype
* Fms-like tyrosine kinase 3 (FLT3) mutation
* Disease status ≥ second complete remission (CR2) at time of HCT
* Detectable disease at time of HCT
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate major organ function, as defined by AST and ALT \< 2 x upper limit of normal, total serum bilirubin \< 2 x upper limit of normal (unless due to hemolysis or Gilbert's syndrome, then no upper limit), creatinine \< 2 x upper limit of normal, unless there is known chronic kidney disease (creatinine must be at baseline for subjects with chronic kidney disease)
* In agreement to use an effective barrier method of birth control to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile
Exclusion Criteria:
* Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
* Serum creatinine \> 2 x upper limit of normal, unless there is known chronic kidney disease (creatinine must be at baseline for subjects with chronic kidney disease), aspartate aminotransferase (AST),alanine aminotransferase (ALT), or total bilirubin \> 2x upper limit of normal
* History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent
* Patient may not be receiving any other antineoplastic agents
* Pregnancy
* Concurrent use of any other investigational agents on a clinical trial
* Prior allogeneic stem cell transplant
* Known hypersensitivity to 5-azacytidine \* Prior treatment with 5-azacytidine is allowed
Post-transplant eligibility and exclusion criteria
Patients will have to meet the following post-transplant eligibility criteria to initiate treatment:
* In complete response (including complete remission with incomplete blood count recovery and marrow complete response) on bone marrow biopsy for response assessment after HCT (typically day +30)
* Patient is within 30-100 days after HCT
* Absolute neutrophil count (ANC) ≥ 1000/µL, platelet count ≥ 20,000/µL
* ECOG performance status 0-2
* Adequate major organ function, as defined by AST and ALT \< 2 x upper limit of normal, total serum bilirubin \< 2 x upper limit of normal (unless due to hemolysis or Gilbert's syndrome, then no upper limit), creatinine \< 2 x upper limit of normal unless there is known chronic kidney disease (creatinine must be at baseline for subjects with chronic kidney disease)
* In agreement to use an effective barrier method of birth control to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile
Patients may not have any of the following post-transplant exclusion criteria:
* Active grade II-IV acute GVHD, for example requiring treatment with steroids at a dose equivalent to prednisone 1mg/kg daily or higher
* Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
* Serum creatinine \> 2 x upper limit of normal unless there is known chronic kidney disease (creatinine must be at baseline for subjects with chronic kidney disease), aspartate aminotransferase (AST),alanine aminotransferase (ALT), or total bilirubin \> 2x upper limit of normal
* History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent
* Pregnancy
* Concurrent use of any other investigational agents on a clinical trial
* Known hypersensitivity to 5-azacytidine \* Prior treatment with 5-azacytidine is allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02204020
Study Brief:
Protocol Section:
NCT02204020