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

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: Epratuzumab

Criteria

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