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Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT02197650
Other study ID # GRASPALL 2012-10-EAP
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information

Verified date November 2018
Source ERYtech Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
suspension of erythrocytes encapsulating L-asparaginase
Erythrocytes encapsulating L-asparaginase

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
ERYtech Pharma

Country where clinical trial is conducted

France, 

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