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 obtained a second complete remission (CR. In France, in patients younger than 60 years old,the HyperCVAD regimen used by the MDAnderson in Houston is generally applied. In older patients (\>=60 years)or young patients \<= 60 years no eligible for intense chemotherapy, a combination of vincristine + Dexamethasone is generally chosen in order to avoid too much toxicity but the result is worse in term of CR. More than 90% of ALL with a B phenotype (2/3 of cases in adults)express the surface antigen CD22 on leukemic blasts which thus represents an interesting target for therapy. Epratuzumab is a humanized anti-CD22 antibody produced by Immunomedics, Inc, Morris Plain (New Jersey, USA). Epratuzumab has already shown efficacy in lymphoma patients. Only one study, including 15 children, has been published so far reporting the efficacy and the toxicity of Epratuzumab in the setting of ALL in monotherapy, one can observe 8 stable disease, 3 progressions and 4 partial responses. When combining chemotherapy and Epratuzumab, 9CR were observed with acceptable toxicity. Tolerance was acceptable. The French GRAALL group proposes to test an age-adapted combination of chemotherapy + Epratuzumab, in refractory/relapses CD22+ B ALL patients in order to improve their prognosis, in term of CR, survival and of number of patients eligible for allograft.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Combination of chemotherapy + Epratuzumab
Vincristine + Dexamethasone + Epratuzumab
Angers University Hospital
Angers, France
University Hospital
Caen, France
HEnri Mondor Hospital
Créteil, France
Edouard Herriot Hospital
Lyon, France
Institut Paoli Calmette
Marseille, France
Nantes University Hospital
Nantes, France
Saint Louis Hospital
Paris, France
St Antoine
Paris, France
Haut-Leveque Hospital
Pessac, France
CHU de Poitiers
Poitiers, France
...and 1 more locations
complete response rate (CR and CRp)
Overall response rate (ORR)(CR, CRp and PR)
Overall survival
Disease free survival
CD22 expression after Epratuzumab
Safety and tolerance of Epratuzumab in combination with chemotherapy
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