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 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT05279859
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years.
* Willing and able to give written informed consent.
* Diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) according to World Health Organization classification.
* Relapsed after or refractory to first-line AML therapy.
* Positive for FLT3 mutation in bone marrow or whole blood.
* Eastern Cooperative Oncology Group performance status ≤ 2 with no deterioration during screening period.
* Adequate hepatic and renal function.
* Recovery from non-hematologic AEs associated with prior therapy to baseline CTCAE v5 Grade 0 or 1, except for AEs not considered a safety risk (eg, alopecia or vitiligo).
* Able to take oral medication with no medical conditions that prevent swallowing and absorbing oral medications.
* Willing to comply with all protocol-required visits, assessments, and procedures.
Exclusion Criteria:
* Diagnosis of AML secondary to prior chemotherapy or other neoplasms (except for MDS).
* Diagnosis of acute promyelocytic leukemia or BCR-ABL-positive leukemia (chronic myeologenous leukemia in blast crisis).
* Clinically active central nervous system leukemia.
* Second or later hematologic relapse or prior salvage therapy for refractory disease.
* For participants being considered for ERAS-007+gilteritinib treatment: prior therapy with ERK inhibitor.
* For participants being considered for ERAS-601+gilteritinib treatment: prior therapy with SHP2 inhibitor.
* Anticancer therapy ≤14 days prior to first dose (except hydroxyurea given for controlling blast count), or ≤5 half-lives prior to first dose, whichever is shorter.
* Palliative radiation ≤7 days prior to first dose.
* Major surgery within 28 days of enrollment.
* Contraindication to gilteritinib use as per local label.
* Known hypersensitivity to any of the components of ERAS-007 or ERAS-601.
* Clinically active infection, requiring systemic therapy.
* Impaired cardiovascular function or clinically significant cardiovascular disease.
* History of thromboembolic or cerebrovascular events ≤6 months prior to first dose.
* History of other malignancy ≤3 years prior to first dose.
* History of retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vein occlusion (RVO), or risk factors to RPED or RVO.
* History of or clinically active interstitial lung disease (ILD), drug induced ILD, or radiation pneumonitis that required steroid treatment.
* Any evidence of severe or uncontrolled systemic disease or evidence of any other significant clinical disorder or laboratory finding that renders the participant inappropriate to participate in the study.
* Pregnant or breastfeeding women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05279859
Study Brief:
Protocol Section:
NCT05279859