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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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
epratuzumab and 90y-epratuzumab
Sequential injections of each product with an escalating dose for radiolabeled Epratuzumab between patients

Primary Outcomes

Determination of MTD by evaluation of hematological and non hematoligical toxicity
time frame:

Secondary Outcomes

rate of haematological response
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Nantes University Hospital.