B ALL Clinical Trial
Official title:
Phase II, Multicenter, Open Label, Prospective to Evaluate Efficacy and Tolerance of a Chemoimmunotherapy With HyperCVAD or Vincristine/Dexamethasone Plus the Anti-CD22 Monovlonal Antobody Epratuzumab for the Treatment of Adult Relapsed/Refractory CD22+ B-Acute Lymphoblastic Leukaemia Patients : CHEPRALL Study, a GRAALL Study.
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.
n/a
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