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

Acute Lymphoblastic Leukemia Clinical Trial

— EAP  

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02197650
• Other study ID #: GRASPALL 2012-10-EAP
• Status: No longer available

Study information

• Verified date: November 2018
• Source: ERYtech Pharma
• Contact: n/a
• Is FDA regulated: No
• 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
• 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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

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	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
ERYtech Pharma

Country where clinical trial is conducted

France,