Acute Lymphoblastic Leukemia Clinical Trial
— EAPOfficial title:
Expanded Access Program for a Multicentre, Open, Non Randomized Study, Evaluating Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase
NCT number | NCT02197650 |
Other study ID # | GRASPALL 2012-10-EAP |
Secondary ID | |
Status | No longer available |
Phase | |
First received | |
Last updated |
Verified date | November 2018 |
Source | ERYtech Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Expanded Access |
Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase.
Status | No longer available |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 55 Years |
Eligibility |
Inclusion Criteria: - Patients with ALL de novo or in relapse or refractory - Eligible to a chemotherapy treatment including L-asparaginase - Known contraindication and/or at risk of toxicity to other L-asparaginase formulation according to investigator opinion based on information available - Patient under 55 years old - Patient informed and consent provided (the 2 parents need to consent for children). Exclusion Criteria: - Patient unable to receive GRASPA due to general or visceral conditions - Serum creatinine = 2 x ULN unless related to ALL - ALT or AST = 3 x ULN unless related to ALL - Active clinical pancreatitis any grade or pancreatic enzyme elevation = 1.5 ULN - Other serious conditions according to investigator's opinion. - Absence of documented serological test for HIV, B and C hepatitis - History of grade 3 transfusional incident or any contraindication to receive blood transfusion - Patient under concomitant treatment likely to cause hemolysis - Presence of specific anti-erythrocyte antibodies preventing from getting a compatible erythrocyte concentrate for the patient. - Patient undergoing yellow fever vaccination. - Patient under phenytoin treatment. - Women of childbearing potential without effective contraception as well as pregnant or breast feeding women. - Patient already included in another clinical trial |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Jean Minjoz - Batiment MEMCP | Besançon | |
France | CHRU Lille - Hôpital Claude-Huriez | Lille | |
France | IHOP | Lyon | |
France | Hôpital de l'Archet 2 | Nice | |
France | Hôpital Saint Louis | Paris | |
France | CHU Rouen - Hôpital des enfants | Rouen | |
France | CHU Saint Etienne Hôpital Nord | Saint-Étienne | |
France | Institut Universitaire du Cancer | Toulouse | |
France | Hôpital BRETONNEAU | Tours | |
France | Hôpital Brabois Enfants | VandÅ“uvre-lès-Nancy |
Lead Sponsor | Collaborator |
---|---|
ERYtech Pharma |
France,
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