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Spots Global Cancer Trial Database for GRASPA Treatment for Patients With Acute Myeloblastic Leukemia

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Trial Identification

Brief Title: GRASPA Treatment for Patients With Acute Myeloblastic Leukemia

Official Title: A Multicenter, Open, Randomized, Controlled Phase IIb Trial Evaluating Efficacy and Tolerability of GRASPA (L-asparaginase Encapsulated in Red Blood Cells, Eryaspase) Plus Low-dose Cytarabine vs Low-dose Cytarabine Alone, in Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) Elderly Patients, Unfit for Intensive Chemotherapy

Study ID: NCT01810705

Interventions

GRASPA

Study Description

Brief Summary: The protocol aims at adding GRASPA (L-asparaginase encapsulated in red blood cells, eryaspase) to standard chemotherapy (low-dose cytarabine) to treat patients older than 65 years diagnosed with AML and unfit for intensive chemotherapy.

Detailed Description: L-asparaginase (ASNase) holds a key role in chemotherapy for Acute Lymphoblastic Leukemia (ALL) in children and young adults. In elderly patients, its efficacy is counterbalanced by its toxicity, which impairs its use. However, a study conducted with GRASPA (L-asparaginase encapsulated in red blood cells, eryaspase) in elderly ALL (study reference "GRASPALL-GRAAL SA2 2008") showed that efficacy/safety profile was positive, paving the way for introducing ASNase benefit into chemotherapy for elderly patients. In adults, Capizzi (1988) reported a significant benefit of ASNase associated with high-dose cytarabine treatment (HiDAC) in Acute Myeloid Leukemia (AML). Indeed, there was an overall statistically superior complete remission rate for HiDAC/ASNase (40%) vs HiDAC (24%) and an overall survival benefit for patients treated with HiDAC/ASNase (19.6 weeks vs 15.9 weeks). Another study in elderly patients also displayed positive results for ASNase treatment (Petti, 1989), as well as recent single case reports that point out the potential benefit of ASNase in different AML or mixed lineage leukemia (Horikoshi, 2009; Rubnitz, 2009). Our preclinical results also showed that an AML cell line and blast cells from the bone marrow of AML patients were sensitive to ASNase in vitro. However, up to now, the toxicity of ASNase for elderly had prevented its use in this population that represents the majority of AML patients. Considering the promising results of ASNase for AML treatment and the better safety profile offered by GRASPA (L-aspariginase encapsulated in red blood cells, erysapase), a multicenter, randomized, controlled IIb trial is open for recruitment. Efficacy and tolerability of GRASPA plus low-dose cytarabine will be evaluated versus low-dose cytarabine alone in treatment of AML patients over 65 year-old, unfit for intensive chemotherapy. One hundred and twenty-three patients (65-85 year-old) newly diagnosed for AML are planned for inclusion in the study. A 2:1 randomization will be respected (82 patients treated with GRASPA® plus low-dose cytarabine and 41 patients treated with low-dose cytarabine alone). Each patient will be followed for 24 months.

Eligibility

Minimum Age: 65 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hôpital l'Archet 1, Nice, Alpes Maritimes, France

Institut Paoli Calmettes, Marseille, Bouche Du Rhone, France

Hôpital JEAN MINJOZ, Besancon, Doubs, France

Hopital Morvan, Brest, Finistere, France

Hôpital Haut-Lévèque, Pessac, Gironde, France

CHRU de Nîmes, Nimes, Guard, France

Hopital de Hautepierre, Strasbourg, Haut Rhin, France

Hopital De Purpan CHU Toulouse, Toulouse, Haute Garonne, France

Hopital Région d'Annecy, Pringy, Haute Savoie, France

Hôpital Saint Eloi, Montpellier, Hérault, France

Hôtel Dieu - CHU de NANTES, Nantes, Loire Atlantique, France

Institut de Cancérologie de la Loire, Saint-priest-en-jarez, Loire, France

Chu D'Angers, Angers, Maine Et Loire, France

Hopital de Brabois, Vandoeuvre Les Nancy, Meurthe Et Moselle, France

Hôpital Claude-Huriez, Lille, Nord, France

CHU Estaing, Clermont-ferrand, Puy De Dome, France

hopital de Perpignan, Perpignan, Pyrénées Orientales, France

Centre Léon Bérard, Lyon, Rhone Alpes, France

Centre hospitalier Lyon Sud, Pierre Benite, Rhone Alpes, France

Centre Henri Becquerel, Rouen, Seine Maritime, France

Groupe Hospitalier Sud, Amiens, Somme, France

Contact Details

Name: X Thomas, Doctor

Affiliation:

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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