The oral presentation will be held on June 17th 2012 by Prof.
Dr. Hervé Dombret, Hospital Saint Louis, Paris (France) at the 17th
Annual Meeting of European Hematology Association (EHA) in Amsterdam
(The Netherlands).
Thirty patients over 55-years old, newly diagnosed with Acute
Lymphoblastic leukemia (ALL) were included in this Phase II trial. The
patients received different doses of erythrocyte encapsulated
Asparaginase in combination with the chemotherapy recommended by the
European Working group for Adult Lymphoblastic Leukemia (EWALL).
Asparaginase is a major and mainstay drug to treat ALL, but current
formulations are not recommended in induction therapy for these older
patients who are particularly frail for toxicity reasons.
Erythrocyte encapsulated Asparaginase introduced in first line induction
therapy showed a good safety profile even in the elderly patients and is
efficient for asparagine depletion. At the optimal dose (100IU/Kg), 91%
of the patients at the end of induction therapy reached a complete
remission and the median overall survival was 15.6 months. The
enrollment of the patients was finished 2 months in anticipation to the
expectations. The study was performed in close collaboration to the
cooperative group GRAALL (Group for Research in Adult Acute
Lymphoblastic Leukemia).
"I would like to thank the investigators of the GRAALL for their
collaboration in setting up and conducting this important clinical
trial. The results demonstrate that our asparaginase formulation offers
the possibility to safely administrate this very useful drug in fragile
older ALL patients for which today no alternative exist." says Dr Yann
Godfrin, Executive Vice President Preclinical and Clinical Reseach.
Hallucinogen-related hospital care linked to higher risk of future mania