Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+
This trial is active, not recruiting.
|Condition||acute lymphoblastic leukemia|
|Treatment||epratuzumab and 90y-epratuzumab|
|Phase||phase 1/phase 2|
|Sponsor||Nantes University Hospital|
|Start date||November 2010|
|End date||June 2016|
|Trial size||21 participants|
|Trial identifier||NCT01354457, BRD 08/12-H|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Determination of MTD by evaluation of hematological and non hematoligical toxicity
rate of haematological response
Male or female participants from 18 years up to 70 years old.
- 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
- 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
|Official title||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|
|Principal investigator||Chevallier Patrice, MD|
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