← Back to all trials
Withdrawn
NCT02577094
Testing a Reduced Conditioning Regimen FB2A2 Preceded by a Fractionated Radio-immunotherapy (RIT) With 90Y-Epratuzumab Before Allogeneic Stem Cell Transplantation for Patients With Lymphocyte B CD22 Positive Acute Lymphoblastic Leukemia
Conditions: Lymphocyte B CD22 Positive Acute Lymphoblastic Leukemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Sponsor: Nantes University Hospital
Summary
Determination of the maximum tolerated dose (MTD) of fractionated RIT with epratuzumab radiolabeled with yttrium-90 (90Y-epratuzumab) preceding a reduced conditioning regimen FB2A2 before allogeneic stem cell transplantation.
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
Source: ClinicalTrials.gov (NCT02577094). StuddyBuddy aggregates publicly available trial information.