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.
Author(s): Domenech C, Thomas X, Chabaud S, Baruchel A, Gueyffier F, Mazingue F, Auvrignon A, Corm S, Dombret H, Chevallier P, Galambrun C, Huguet F, Legrand F, Mechinaud F, Vey N, Philip I, Liens D, Godfrin Y, Rigal D, Bertrand Y
Affiliation(s): Institut d'Hemato-Oncologie pediatrique, Hospices civils de Lyon, Universite Claude Bernard, France. firstname.lastname@example.org
Publication date & source: 2011-04, Br J Haematol., 153(1):58-65. Epub 2011 Feb 20.
Publication type: Clinical Trial, Phase I; Clinical Trial, Phase II; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
l-asparaginase encapsulated within erythrocytes (GRASPA((R)) ) 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((R)) 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((R)) (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((R)) was effective at depleting l-asparagine. One single injection of 150 iu/kg of GRASPA((R)) provided similar results to 8 x 10,000 iu/m(2) intravenous injections of E. colil-ASNase. The safety profile of GRASPA((R)) 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((R)) . (c) 2011 Blackwell Publishing Ltd.