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

Status:

NO_LONGER_AVAILABLE

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

Lead Sponsor:

ERYtech Pharma

Conditions:

Acute Lymphoblastic Leukemia

Eligibility:

All Genders

Up to 55 years

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 authori...

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT02197650

Last Update

December 4 2018

Active Locations (10)

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Page 1 of 3 (10 locations)

Hôpital Jean Minjoz - Batiment MEMCP

Besançon, France, 25030

CHRU Lille - Hôpital Claude-Huriez

Lille, France, 59037

IHOP

Lyon, France, 69373