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:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT07285668
Eligibility Criteria:
Inclusion Criteria:
* Patients with high-risk myeloid or lymphoid malignancies determined to be eligible to undergo a related, allo-SCT using Disease Risk Index (DRI), including the conditions listed below. These criteria apply BEFORE cyto-reductive therapy given within 28 days of planned conditioning:
* Refractory acute myelogenous or lymphoid leukemia
* Relapsed acute myelogenous or lymphoid leukemia
* Myelodysplastic syndromes with 5 percent or more blasts
* Chronic myelogenous leukemia in chronic phase 3 or more, blast phase presently, or second accelerated phase
* Recurrent or refractory malignant lymphoma or Hodgkin's disease with less than a partial response at transplant
* High risk chronic lymphocytic leukemia defined as no response or stable disease to the most recent treatment regimen
* Other high risk hematologic malignancies for which allo-SCT is deemed clinically necessary per PI and based on institutional standards
* The donor for the allo-SCT will have been identified prior to participant recruitment and must be:
* Related AND
* Matched OR mismatched OR haploidentical at Human Leukocyte Antigen (HLA) HLA-A, -B, -C, and -DRB1 by molecular methods
* Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
* Ability to understand and willingness to sign written informed consent document
* Willing to comply with all study procedures and be available for the duration of the study
* Individuals in sexual relationships that could result in pregnancy or impregnation of their partner must use an acceptable method of contraception§ from enrollment until 4 weeks after completing study treatment.
Exclusion Criteria:
* Poor organ function as follows (According to the pre-transplant workups results):
* Creatinine greater than or equal to 2.0 mg/dL
* Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) greater than or equal to 5 x Upper Limit of Normal (ULN). Liver biopsy preferred for such patients.
* Bilirubin greater than or equal to 3 x ULN (unless Gilbert's syndrome)
* Diffusing capacity of the Lungs for Carbon Monoxide (DLCO) less than 50 percent corrected for hemoglobin
* Left ventricular ejection fraction or shortening fraction less than 40 percent
NOTE: Exceptions to the above organ function exclusion criteria are allowable only with assent of the PI since the risks and benefits must be addressed for patients with potentially incurable hematologic malignancies. Such exceptions will be clearly documented in the subject's research record and will not be considered a deviation.
* Patients with uncontrolled intercurrent illness
* Patients with psychiatric illness/social situations that would limit compliance with study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07285668
Study Brief:
Protocol Section:
NCT07285668