Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+
NCT ID: NCT01354457
Last Updated: 2014-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
21 participants
INTERVENTIONAL
2010-11-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Epratuzumab and 90Y-Epratuzumab
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
Epratuzumab and 90Y-Epratuzumab
Sequential injections of each product with an escalating dose for radiolabeled Epratuzumab between patients
Interventions
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Epratuzumab and 90Y-Epratuzumab
Sequential injections of each product with an escalating dose for radiolabeled Epratuzumab between patients
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chevallier Patrice, MD
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Kraeber-Bodere Françoise, MD
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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CHU Nantes
Nantes, , France
Countries
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References
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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.
Other Identifiers
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BRD 08/12-H
Identifier Type: -
Identifier Source: org_study_id
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