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.

Carine Domenech; Xavier Thomas; Sylvie Chabaud; Andre Baruchel; François Gueyffier; Françoise Mazingue; Anne Auvrignon; Selim Corm; Herve Dombret; Patrice Chevallier; Claire Galambrun; Françoise Huguet; Faezeh Legrand; Françoise Mechinaud; Norbert Vey; Irène Philip; David Liens; Yann Godfrin; Dominique Rigal; Yves Bertrand

doi:10.1111/j.1365-2141.2011.08588.x

Journal articles

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.

Carine Domenech ^{1, *} Xavier Thomas ² Sylvie Chabaud Andre Baruchel François Gueyffier ^{3, 4} Françoise Mazingue Anne Auvrignon ⁵ Selim Corm Herve Dombret ⁶ Patrice Chevallier Claire Galambrun ⁷ Françoise Huguet ⁸ Faezeh Legrand ⁹ Françoise Mechinaud ¹⁰ Norbert Vey ¹¹ Irène Philip ¹² David Liens Yann Godfrin Dominique Rigal ¹³ Yves Bertrand ¹

* Corresponding author

1 Hôpital Edouard Herriot [CHU - HCL]

2 equipe 14

UNICANCER/CRCL - Centre de Recherche en Cancérologie de Lyon, Hôpital Edouard Herriot [CHU - HCL]

3 Evaluation et modélisation des effets thérapeutiques

Département biostatistiques et modélisation pour la santé et l'environnement [LBBE]

4 CIC CHU Lyon (inserm)

5 CHU Trousseau [APHP]

6 Lymphocyte et cancer

7 Service d'Hématologie pédiatrique, Hôpital de la Timone, Marseille

8 Laboratoire d'Hématologie [Purpan]

9 Service d'hématologie

10 Children's Cancer Center

11 Hematology (IPC-Marseille)

12 FNCLCC - Fédération Nationale des Centres de Lutte Contre le Cancer

13 EFS - Alpes-Méditerranée - Etablissement Français du Sang - Alpes-Méditerranée

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(®) .

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Journal articles

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Life Sciences [q-bio] / Cancer

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https://hal.archives-ouvertes.fr/hal-00798134
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Submitted on : Friday, March 8, 2013 - 9:42:37 AM
Last modification on : Wednesday, August 25, 2021 - 3:09:01 AM

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.

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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.

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