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 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT01354457
Eligibility Criteria:
Inclusion Criteria:
* Age 18-70 years
* B-ALL (OMS) with \>=20% of blasts in bone marrow
* CD22+ expression \>=70% of the blast population
* All previously treated ALL patients who have experienced relapse or treatment failure
* At least 15 days since previous treatment
* Performance status 0 - 2
* Creatinine clearance \>= 50 ml/min (Cockroft formula).
* Serum bilirubin \<= 30 mmol/l
* Written informed consent
Exclusion Criteria:
* T-ALL
* Meningeal involvement
* CD22 expression on tumor cells or \< 70%
* HIV positive
* Active Hepatitis B or C
* Active infection within 7 days of starting treatment
* Left ventricular ejection fraction \< 50%.
* Contra-indication to 90Y-DOTA-hLL2
* 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 5 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01354457
Study Brief:
Protocol Section:
NCT01354457