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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT02577094
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18
* Acute lymphoblastic Leukemia (ALL) CD22 + B-type in RC1 with high risk
* B-Cell Acute Lymphoblastic Leukemia (ALL) CD22+ beyond RC1.
* Expression of CD22 ≥ 30% in tumor population evaluated by flow cytometry or immunohistochemistry at diagnosis stage or relapse stage.
* HLA-identical donor intra family or not, without major HLA mismatch (9 / 10th accepted) without contra-indication for stem cell mobilization
* ECOG (Eastern Cooperative Oncology Group) ≤ 2
* Having or not received previously Epratuzumab
* Eligible for an allograft with reduced conditioning regimen
* With a signed informed consent
* Patient in age of children bearing with adequate contraception
* Patient affiliated to or beneficiary of the National Health Service
Exclusion Criteria:
* T-cell ALL
* Known hypersensibility to 90Y-DOTA-hLL2
* Immunization against hLL2 for patients having already received one or several injections of this antibody
* Patient eligible for myeloablative conditioning regimen
* Other prior malignancies must have had at least a 2-year disease-free interval with the exception of successfully treated carcinoma skin cancer or carcinoma in situ of the cervix.
* Patient with progressive psychiatric condition.
* HIV positive, hepatitis B-antigen positive, or hepatitis C positive patients who need a treatment
* Pregnant or breast-feeding women
* Women with childbearing potential without effective contraception
* Serious concomitant and uncontrolled infection
* Usual contraindications in the allogeneic transplant:
* Adult patient protected by the French law
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02577094
Study Brief:
Protocol Section:
NCT02577094