Clinical trial · Interventional
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
NCT02577094CI-TRIAL-00115706EPRALLOwithdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphocyte B CD22 Positive Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 90Y-DOTA-Epratuzumab IgG/Epratuzumab IgG | Drug | — | UNRESOLVED |
| allogeneic stem cell transplantation. | Biological | — | UNRESOLVED |
| Busulfan | Drug | Busulfan | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Thymoglobulines | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determination of the maximum tolerated dose (MTD)
- timeFrame
- 6 weeks
- description
- Patient toxicity will be evaluated according to NTCAE V4 criteria.
Secondary outcomes (15)
- measure
- Overall survival
- timeFrame
- Month 12
- measure
- Disease free survival at one year post-transplant
- timeFrame
- Month 12
- measure
- Incidence of relapse at 1 year post-transplant
- timeFrame
- Month 12
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.