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

Phase 1

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Drug: Epratuzumab and 90Y-Epratuzumab

• Registration Number: NCT01354457
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-17
• Study Start: 2010-11
• Status Verified: 2011-05
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-16
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-06-25
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epratuzumab and 90Y-Epratuzumab	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
rate of haematological response		To determine the hematologic response

Trial Locations

Locations (1)

CHU Nantes; 🇫🇷 Nantes, France