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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT01824693
Eligibility Criteria:
Inclusion Criteria:
* Patients must have a strong clinical suspicion of JMML, based on a modified category 1 of the revised diagnostic criteria; specifically, eligible patients must have all of the following:
* Splenomegaly
* Absolute monocyte count (AMC) \> 1000/uL
* Blasts in peripheral blood (PB)/bone marrow (BM) \< 20%
* For the 7-10% of patients without splenomegaly, the diagnostic entry criteria must include all other features described above and at least 2 of the following criteria:
* Circulating myeloid precursors
* White blood cell (WBC) \> 10,000/uL
* Increased fetal hemoglobin (HgbF) for age
* Sargramostim (GM-CSF) hypersensitivity OR, patients must have been previously diagnosed with JMML
* Patients must be previously untreated with HCT
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Patients with a known germline mutation of PTPN11 (Noonan?s Syndrome) are not eligible
* Patients with a known history of NF1 (Neurofibromatosis Type 1) and either
* A history of a tumor of the central nervous system (astrocytoma or optic glioma), or
* A malignant peripheral nerve sheath tumor with a complete remission of \< 1 year are not eligible
* Human immunodeficiency virus (HIV) positive patients are not eligible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
18 Years
Study:
NCT01824693
Study Brief:
Protocol Section:
NCT01824693