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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epratuzumab and 90Y-Epratuzumab | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epratuzumab and 90Y-Epratuzumab | Drug | Sequential injections of each product with an escalating dose for radiolabeled Epratuzumab between patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of MTD by evaluation of hematological and non hematoligical toxicity | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| rate of haematological response | To determine the hematologic response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chevallier Patrice, MD | Nantes University Hospital | Principal Investigator |
| Kraeber-Bodere Françoise, MD | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nantes | Nantes | 44000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26687796 | Derived | Chevallier 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. |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C448700 | epratuzumab |
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