Status:
COMPLETED
Multi-centric Study
Lead Sponsor:
Nantes University Hospital
Conditions:
B ALL
CD22+ Expression
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients with relapsed/refractory adult acute lymphoblastic leukemia (ALL)have a very dismal prognosis. In this case, allogeneic transplantation is the only curative treatment when patient have obtain...
Eligibility Criteria
Inclusion
- Age \>= 18 years
- B-ALL (OMs) with \>= 20 % of blasts in bone marrow
- CD22+ expression \>= 30% of the blast population
- Refractory B-ALL defined by treatment failure after 2 successive courses of induction therapy or relapse \< 6 months after first CR
- First relapse of B-ALL
- Second relapse or beyond
- Performance status 0-2
- Creatinine clearance \>= 50 ml/min (Cockroft formula)
- Serum bilirubine \<= 30 µmom/l
- Written informed consent
Exclusion
- T-ALL
- Meningeal involvement
- CD22 expression on tumor cells or \< 30%
- HIV positive
- Active Hepatitis B or C
- Left ventricular ejection fraction \< 50% in patients \<60 years
- Contra-indication to Epratuzumab
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01219816
Start Date
November 1 2010
End Date
November 1 2016
Last Update
February 27 2018
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Angers University Hospital
Angers, France, 49933
2
University Hospital
Caen, France, 14000
3
HEnri Mondor Hospital
Créteil, France, 94010
4
Edouard Herriot Hospital
Lyon, France, 69437