Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Drug: Epratuzumab and 90Y-Epratuzumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epratuzumab and 90Y-Epratuzumab<br>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 | Drug: Epratuzumab and 90Y-Epratuzumab<br>* Sequential injections of each product with an escalating dose for radiolabeled Epratuzumab between patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of haematological response | To determine the hematologic response |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient with relapsing or refractory CD22+B-acute lymphoblastic leukemia (ALL)