Clinical trial NCT01354457: Safety and Efficacy of Radio-immunotherapy (RIT) for Patients With Relapse or Refractory Acute Lymphoblastic Leukaemia (ALL) B CD22+
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Lymphoblastic Leukemia
Keywords: Patient with relapsing or refractory CD22+B-acute lymphoblastic leukemia (ALL)
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-05-16
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Determination of MTD by evaluation of hematological and non hematoligical toxicity
Secondary outcomes:
measure: rate of haematological response
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
affiliation: Nantes University Hospital
name: Chevallier Patrice, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Kraeber-Bodere Françoise, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chevallier P, Eugene T, Robillard N, Isnard F, Nicolini F, Escoffre-Barbe M, Huguet F, Hunault M, Marcais A, Gaschet J, Cherel M, Guillaume T, Delaunay J, Peterlin P, Eveillard M, Thomas X, Ifrah N, Lapusan S, Bodet-Milin C, Barbet J, Faivre-Chauvet A, Ferrer L, Bene MC, Le Houerou C, Goldenberg DM, Wegener WA, Kraeber-Bodere F. (90)Y-labelled anti-CD22 epratuzumab tetraxetan in adults with refractory or relapsed CD22-positive B-cell acute lymphoblastic leukaemia: a phase 1 dose-escalation study. Lancet Haematol. 2015 Mar;2(3):e108-17. doi: 10.1016/S2352-3026(15)00020-4. Epub 2015 Feb 25.