In:
British Journal of Haematology, Wiley, Vol. 153, No. 1 ( 2011-04), p. 58-65
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. coli l ‐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. coli l ‐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. coli l ‐ASNase and there was also no difference between the three doses of GRASPA ® .
Type of Medium:
Online Resource
ISSN:
0007-1048
,
1365-2141
DOI:
10.1111/bjh.2011.153.issue-1
DOI:
10.1111/j.1365-2141.2011.08588.x
Language:
English
Publisher:
Wiley
Publication Date:
2011
detail.hit.zdb_id:
80077-6
detail.hit.zdb_id:
1475751-5
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