Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+ (RIT 90YEpra)

Nantes University Hospital (NUH)

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: Epratuzumab and 90Y-Epratuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01354457

BRD 08/12-H

Details and patient eligibility

About

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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Epratuzumab and 90Y-Epratuzumab

Experimental group

Description:

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

Treatment:

Drug: Epratuzumab and 90Y-Epratuzumab