Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-28 @ 2:11 PM
Study NCT ID:
NCT02197650
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2018-12-04
First Post:
2014-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access Program: 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
Sponsor:
ERYtech Pharma
Organization:
Study Overview
Official 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
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EAP
Brief Summary:
Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase.
Detailed Description:
Some patients can not be eligible to other clinical trials / program sponsored by Erytech Pharma but could have a benefit to be treated with GRASPA. Following discussion with French regulatory authorities, it has been suggested to propose access to GRASPA to patients unable to receive any other form of L-asparaginase and not eligible to the ongoing study or other program. This exploratory study should allow it in an "Expended Access Program" framework.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: