Clinical trial · Interventional
Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+
Evaluation of the Efficacy and Tolerance of Fractionated Radio-immunotherapy With 90Y-Epratuzumab (90Y-hLL2) for Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukaemia Patients
NCT01354457CI-TRIAL-00014934RIT 90YEpraunknownPhase 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)
The purpose of this study is to determine whether fractionated RIT with Epratuzumab and radiolabeled Epratuzumab are effective in the treatment of relapsing or refractory ALL.
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 |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epratuzumab and 90Y-Epratuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Epratuzumab and 90Y-Epratuzumab
- description
- Escalating dose schedule with 5 cohort. For each cohort 3 patients will receive Radio-immunotherapy (RIT ) at Day 1 and Day 8 ± 2 First cohort : 92,5 MBq/m² of 90Y-DOTA-hLL2 associated with hLL2 Second cohort : 185 MBq/m² d'90Y-DOTA-hLL2 associated with hLL2 Third cohort : 277,5 MBq/m² d'90Y-DOTA-hLL2 associated with hLL2 Fourth cohort : 370 MBq/m² d'90Y-DOTA-hLL2 associated with hLL2 Fifth cohort : 462.5 MBq/m² d'90Y-DOTA-hLL2 associated with hLL2
- interventionNames
- Drug: Epratuzumab and 90Y-Epratuzumab
Primary outcomes (1)
- measure
- Determination of MTD by evaluation of hematological and non hematoligical toxicity
- description
- The primary endpoint is to evaluate the incidence of dose limiting toxicities (DLT) in order to determine the maximal tolerated dose (MTD) in a dose escalating study design
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-70 years * B-ALL (OMS) with \>=20% of blasts in bone marrow * CD22+ expression \>=70% of the blast population * All previously treated ALL patients who have experienced relapse or treatment failure * At least 15 days since previous treatment * Performance status 0 - 2 * Creatinine clearance \>= 50 ml/min (Cockroft formula). * Serum bilirubin \<= 30 mmol/l * Written informed consent Exclusion Criteria: * T-ALL * Meningeal involvement * CD22 expression on tumor cells or \< 70% * HIV positive * Active Hepatitis B or C * Active infection within 7 days of starting treatment * Left ventricular ejection fraction \< 50%. * Contra-indication to 90Y-DOTA-hLL2 * Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 5 years * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Participation at the same time in another study in which investigational drugs are used * Absence of written informed consent
References
Publications (1)
- DERIVEDChevallier P, Eugene T, Robillard N, Isnard F, Nicolini F, Escoffre-Barbe M, Huguet F, Hunault M, Marcais A, Gaschet J, Cherel M, Guillaume T, Delaunay J, Peterlin P, Eveillard M, Thomas X, Ifrah N, Lapusan S, Bodet-Milin C, Barbet J, Faivre-Chauvet A, Ferrer L, Bene MC, Le Houerou C, Goldenberg DM, Wegener WA, Kraeber-Bodere F. (90)Y-labelled anti-CD22 epratuzumab tetraxetan in adults with refractory or relapsed CD22-positive B-cell acute lymphoblastic leukaemia: a phase 1 dose-escalation study. Lancet Haematol. 2015 Mar;2(3):e108-17. doi: 10.1016/S2352-3026(15)00020-4. Epub 2015 Feb 25. PMID 26687796