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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT05579769
Eligibility Criteria:
Inclusion criteria
Diagnosis:
* Patients with high risk acute lymphoblastic leukemia in first remission. Examples include, but are not limited to, patients with certain leukemic cell cytogenetic findings (e.g. t(9;22) or t(4;11)); delayed response to induction chemotherapy; re-emergence of leukemic blasts by MRD (at any level) in patients previously MRD negative; persistently detectable MRD at lower levels; early T-cell precursor (ETP) ALL.
* Patients with acute lymphoblastic leukemia beyond first remission.
* Patients with Hodgkin's disease beyond first remission or with refractory disease.
* Patients with chronic myelogenous leukemia.
* Patients with primary or secondary myelodysplastic syndrome.
* Patients with Non-Hodgkin's lymphoma beyond first remission or with refractory disease.
* Patients with de novo acute myeloid leukemia in or beyond first remission or with relapsed or refractory disease, or myeloid sarcoma (extra-medullary AML).
* Patients with secondary acute myeloid leukemia.
* NK cell lymphoblastic leukemia in any CR.
* Biphenotypic, bilineage, or undifferentiated leukemia.
* Juvenile Myelomonocytic Leukemia (JMML)
* All patients with prior evidence of CNS leukemia must be treated and be in CNS CR.
Patients must have a related or unrelated donor matched at 12 of 12 HLA alleles.
Patient must have a Karnofsky/Lansky score of 70 or higher.
Patients must be 12 years of age or older.
Patients must have a shortening fraction \>26% or left ventricular ejection fraction \>40%.
Patients must have bilirubin less than or equal to 2.5 mg/dL and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal.
Patients must have creatinine clearance, or a glomerular filtration rate (GFR), greater than 70 mL/min/1.73m2.
Patients must be free of severe infection that upon determination of principal investigator precludes BMT.
Patients must have FVC \>50% predicted OR, if unable to perform pulmonary function testing, must maintain pulse oximetry oxygen saturation \>92% on room air.
Female patients of childbearing age must have a negative pregnancy test.
Exclusion criteria
* Patients who have undergone prior HCT.
* Patients who have a peripheral blood stem cell graft source.
* Patients who have a non-permissive mismatch at the DPB1 allele.
* Patients who are HIV positive.
* Patients positive for Hepatitis B surface antigen (HBsAg).
* Patients positive for Hepatitis C.
* Patients with latent tuberculosis with positive TB IFN gamma release assay.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05579769
Study Brief:
Protocol Section:
NCT05579769