Trials / No Longer Available
No Longer AvailableNCT02197650
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
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
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- ERYtech Pharma · Industry
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | suspension of erythrocytes encapsulating L-asparaginase | Erythrocytes encapsulating L-asparaginase |
Timeline
- First posted
- 2014-07-23
- Last updated
- 2018-12-04
Locations
10 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02197650. Inclusion in this directory is not an endorsement.