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Clinical Trial · 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
Overview
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.
Drug / Compound
Epratuzumab
Isotope(s):
YTTRIUM-90
Radioisotope: Y-90
Theranostic Role: Therapeutic Agent, SPECT Imaging & PET Imaging
T1/2 (Half-Life): 2.7 Days
Decay Mode: BETA
Energy: max 2.2 MeV
Range: In Tissue: Avg 2.5 mm, Max 11 mm; In Air: 35 feet
Decay Daughters: Zr90 (Stable)
Status: FDA Approvals: SIR-SPHERES® (2000), THERASPHERES® (2021)
Target(s):
- CD22
Ligand Class: Antibodies
Chelator: DOTA
Eligibility
Inclusion
- Expression of CD22 ≥ 30% in tumor population evaluated by flow cytometry or immunohistochemistry at diagnosis stage or relapse stage.
- Eligible for an allograft with reduced conditioning regimen
- B-Cell Acute Lymphoblastic Leukemia (ALL) CD22+ beyond RC1.
- Patient affiliated to or beneficiary of the National Health Service
- ECOG (Eastern Cooperative Oncology Group) ≤ 2
- Having or not received previously Epratuzumab
- HLA-identical donor intra family or not, without major HLA mismatch (9 / 10th accepted) without contra-indication for stem cell mobilization
- Acute lymphoblastic Leukemia (ALL) CD22 + B-type in RC1 with high risk
Exclusion
- Known hypersensibility to 90Y-DOTA-hLL2
- Women with childbearing potential without effective contraception
- Immunization against hLL2 for patients having already received one or several injections of this antibody
- Usual contraindications in the allogeneic transplant:
- Adult patient protected by the French law
- Patient eligible for myeloablative conditioning regimen
- Serious concomitant and uncontrolled infection
- HIV positive, hepatitis B-antigen positive, or hepatitis C positive patients who need a treatment
- Pregnant or breast-feeding women
- T-cell ALL
- Patient with progressive psychiatric condition.
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