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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT06930105
Eligibility Criteria:
Inclusion Criteria:
Patients (Age 18-60 years ) with an ECOG performance status of 0-2 and HCT-CI score \<3.
2\. Diagnosis: Confirmed Philadelphia chromosome-negative (Ph-) acute B-cell lymphoblastic leukemia (B-ALL) by:
* Bone marrow morphology
* Cytochemistry
* Immunophenotyping (CD19-positive by flow cytometry, ≥20% positivity on leukemic cells)
* Chromosomal analysis
* Molecular/genetic testing. 3. Planned allo-HSCT candidates must have an eligible hematopoietic stem cell donor, including:
* HLA-matched sibling donors
* Unrelated donors (9/10 or 10/10 HLA allele-matched by high-resolution typing)
* Haploidentical related donors. 4. No significant organ dysfunction:
* Liver: ALT/AST ≤3× upper limit of normal (ULN); total bilirubin ≤2× ULN.
* Kidney: BUN and serum creatinine ≤1.25× ULN.
* Cardiac:
* No acute myocardial infarction or severe arrhythmia on ECG.
* Left ventricular ejection fraction (LVEF) ≥50% on echocardiography; no significant cardiomegaly, valvular disease, or congenital heart defects.
* Pulmonary: FEV1, FVC, and DLCO ≥60% of predicted values. 5. Contraception:
* Men, women of childbearing potential (postmenopausal women must be amenorrheic for ≥12 months), and their partners must use investigator-approved effective contraception during treatment and for ≥12 months after the last study intervention.
6\. Informed consent: Patients and their legal guardians must provide written informed consent, demonstrate willingness to undergo allo-HSCT, and agree to comply with treatment protocols, follow-up schedules, and laboratory tests.
Exclusion Criteria:
1. Non-de novo patients(i.e., relapsed/refractory disease).
2. BCR-ABL1 fusion gene-positive (Ph+ ALL confirmed by molecular testing).
3. Uncontrolled active infections or viral diseases:
* Active bacterial, viral, or fungal infections requiring treatment.
* Hepatitis B: HBsAg-positive or HBcAb-positive with detectable HBV DNA in peripheral blood.
* Hepatitis C: HCV antibody-positive with detectable HCV RNA.
* Syphilis: Positive TRUST test.
* HIV: HIV antibody-positive.
4. Major organ dysfunction or comorbidities:
* Cardiovascular:
* Uncontrolled hypertension, hypertensive crisis, or encephalopathy.
* History of congestive heart failure (CHF), unstable angina, clinically significant arrhythmias (e.g., ventricular fibrillation, ventricular tachycardia).
* Arterial thrombosis within 3 months (e.g., stroke, transient ischemic attack).
* Symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months.
* Coronary angioplasty, defibrillation, or other high-risk cardiovascular procedures.
* Pulmonary: Severe respiratory insufficiency.
* Gastrointestinal: Active bleeding within 3 months.
5. Uncontrolled concurrent illnesses that may compromise safety or study integrity.
6. Active or untreated central nervous system (CNS) involvement (e.g., CNS leukemia, epilepsy requiring therapy).
7. Pregnancy, lactation, or plans for pregnancy within 1 year post-infusion or during the study period.
8. Uncontrolled active infections (excluding uncomplicated UTIs or upper respiratory infections).
9. Hypersensitivity to blinatumomab or its components.
10. Inability to provide informed consent or comply with study procedures.
11. Investigator discretion: Any condition deemed to jeopardize patient safety or interfere with study objectives.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06930105
Study Brief:
Protocol Section:
NCT06930105