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 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT06814405
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of haematological malignancy undergoing high-dose chemotherapy (sub- or myeloablative)
* Age between 18-75 years
* WHO Performance Status \< 2 or Karnofsky ≥ 60%
* Adequate organ function:
* FE≥ 50% and absence of significant electrocardiographic changes
* eVFG \> 40 ml/min and/or creatinine ≤ 1.6 mg/dl (CPK-EPI formula)
* total bilirubin ≤ 3 mg/ml
* AST/ALT ≤ 5 ULN
* SpO2 ≥ 94%
* Reinfusion ≥ 2x106 CD34+/Kg
* Presence of a 24-hour SARS-COV-2 vaccinated caregiver
* Home \< 45 minutes' drive from hospital
* Informed consent obtained
Exclusion Criteria:
* Diagnosis of haematological malignancy at onset or in progression
* Significant cardiovascular disease: heart failure NYHA class 3 or 4, uncontrolled angina, history of myocardial infarction, unstable angina or stroke in the previous 6 months, uncontrolled hypertension, significant arrhythmias not controlled by medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06814405
Study Brief:
Protocol Section:
NCT06814405