NCT02577094WithdrawnPhase 1
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
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Nantes University Hospital
- Primary Endpoint
- Determination of the maximum tolerated dose (MTD)
Study Overview
Brief 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.
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Acute lymphoblastic Leukemia (ALL) CD22 + B-type in RC1 with high risk
- •B-Cell Acute Lymphoblastic Leukemia (ALL) CD22+ beyond RC
- •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
Outcomes
Primary Outcomes
Determination of the maximum tolerated dose (MTD)
Time Frame: 6 weeks
Patient toxicity will be evaluated according to NTCAE V4 criteria.
Secondary Outcomes
- Incidence of relapse at 1 year post-transplant(Month 12)
- Hematologic reconstitutions post-transplant(Month 3)
- Residual disease post-transplant(Month 3 and Month 12)
- Overall survival(Month 12)
- Non relapse mortality at day 100 post-transplant(Day 100)
- Disease free survival at one year post-transplant(Month 12)
- Non relapse mortality at one year post-transplant(Month 12)
- Immune reconstitutions post-transplant(Month 3)
- Incidence of acute and chronic GVHD(Month 3 and 12)
- Toxicity of RIT(Week 6 and Month 12)
- Immunization analysis : detection of antibody anti epratuzumab(Month 12)
- Dosage of FLT3-ligand in plasma and correlation with efficacy and toxicity of RIT(Month 12)
- Chimerism post-transplant(Month 3)
- Tolerance of RIT(Week 6 and Month 12)
- 90Y-DOTA-Epratuzumab blood pharmacokinetics(Month 2)
Investigators
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