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 @ 3:05 AM
Ignite Modification Date:
2025-12-25 @ 3:05 AM
NCT ID:
NCT03862833
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-70 years old
* Patients with a hematological disease eligible for a haplo-SCT using the Baltimore regimen as conditioning regimen (Luznik, BBMT, 2008) (See 5.1.2)
* Patients with no HLA matched sibling or unrelated donors
* ECOG \<=2
* Signed informed consent
* Patient affiliated to or beneficiary of the National Health Service
* Patients previously transplanted are eligible to the study
Exclusion Criteria:
* Patients with a HLA matched sibling or unrelated donor
* Active uncontrolled infections
* HIV positive, active Hepatitis B or C
* Childbearing or child-breastfeading women
* Women or men without effective contraceptive barrier if needed
* Left ventricular ejection fraction \< 50% with no previous severe cardiopathy
* Respiratory insufficiency defined as DLCO \<40% of the corrected value
* Creatinine clearance \<50 ml/min
* Serum bilirubin \>2.5 or transaminases \>5 fold of normal value except if due to the hematological disease
* Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Participation at the same time in another study in which investigational drugs are used
* Absence of written informed consent
* Contra-indication to Zoledronic acid: known hypersensitivity to Zoledronic acid or other bisphosphonate or Zoledronic acid formulation (excipients)
* Recent or programmed dental care
* Contra-indication to IL-2: known hypersensitivity to IL-2 or IL-2 formulation (excipients)
* No previous ou current use of zoledronic acid
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03862833
Study Brief:
Protocol Section:
NCT03862833