l-asparaginase loaded red blood cells in refractory or relapsing acute lymphoblastic leukaemia in children and adults: results of the GRASPALL 2005-01 randomized trial. - Archive ouverte HAL Access content directly
Journal Articles British Journal of Haematology Year : 2011

l-asparaginase loaded red blood cells in refractory or relapsing acute lymphoblastic leukaemia in children and adults: results of the GRASPALL 2005-01 randomized trial.

Sylvie Chabaud
  • Function : Author
Andre Baruchel
  • Function : Author
Françoise Mazingue
  • Function : Author
Selim Corm
  • Function : Author
Patrice Chevallier
Norbert Vey
David Liens
  • Function : Author
Yann Godfrin
  • Function : Author
Yves Bertrand
  • Function : Author
  • PersonId : 899520

Abstract

l-asparaginase encapsulated within erythrocytes (GRASPA(®) ) should allow serum asparagine depletion over a longer period than the native form of the enzyme, using lower doses and allowing better tolerance. The GRASPALL 2005-01 study, a multicentre randomized controlled trial, investigated three doses of GRASPA(®) for the duration of asparagine depletion in a phase I/II study in adults and children with acute lymphoblastic leukaemia (ALL) in first relapse. Between February 2006 and April 2008, 18 patients received GRASPA(®) (50 iu/kg: n = 6,100 iu/kg: n = 6, 150 iu/kg: n = 6) after randomization, and six patients were assigned to the Escherichia coli native l-asparaginase (E. colil-ASNase) control group. GRASPA(®) was effective at depleting l-asparagine. One single injection of 150 iu/kg of GRASPA(®) provided similar results to 8 × 10,000 iu/m(2) intravenous injections of E. colil-ASNase. The safety profile of GRASPA(®) showed a reduction in the number and severity of allergic reactions and a trend towards less coagulation disorders. Other expected adverse events were comparable to those observed with E. colil-ASNase and there was also no difference between the three doses of GRASPA(®) .

Domains

Cancer

Dates and versions

hal-00798134 , version 1 (08-03-2013)

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Carine Domenech, Xavier Thomas, Sylvie Chabaud, Andre Baruchel, François Gueyffier, et al.. l-asparaginase loaded red blood cells in refractory or relapsing acute lymphoblastic leukaemia in children and adults: results of the GRASPALL 2005-01 randomized trial.. British Journal of Haematology, 2011, 153 (1), pp.58-65. ⟨10.1111/j.1365-2141.2011.08588.x⟩. ⟨hal-00798134⟩
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