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

• Status: Withdrawn
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Collaborators: Gilead Sciences; Immunomedics, Inc.; Institut Cancerologie de l'Ouest
• Treatments: Busulfan; Epratuzumab; Fludarabine; Thymoglobulin

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