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 (EPRALLO)

Nantes University Hospital (NUH)

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Lymphocyte B CD22 Positive Acute Lymphoblastic Leukemia

Treatments

Biological: allogeneic stem cell transplantation.

Biological: Thymoglobulines

Drug: Fludarabine

Drug: Busulfan

Drug: 90Y-DOTA-Epratuzumab IgG/Epratuzumab IgG

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02577094

RC14_0429

Details and patient eligibility

About

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.

Full description

Physical examination (screening and follow-up)
Complete blood counts (screening and follow-up)
Dosage of FLT3-ligand in plasma (screening and follow-up)
Blood ionogramme, creatinine hepatic work-up (screening and follow-up)
Left ventricular ejection fraction at pre-implant assessment
Immunization test (screening and follow-up)
Bone marrow aspiration or/and blood CD 22 immunophenotype for minimal residual disease evaluation (screening and follow-up)
All exams which were initially abnormal and which are necessary for response evaluation and All exams which are needed in case of relapse suspicion.
Pharmacokinetic of 90Y-hLL2

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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