Clinical trial NCT02197650: 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
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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Acute Lymphoblastic Leukemia
Keywords: ALL L-asparaginase encapsulated erythrocytes
Lead sponsor: ERYtech Pharma
Sponsor class: INDUSTRY
First posted: 2014-07-23
Sex: ALL
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Hôpital Jean Minjoz - Batiment MEMCP
city: Lille
country: France
facility: CHRU Lille - Hôpital Claude-Huriez
city: Lyon
country: France
facility: IHOP
city: Nice
country: France
facility: Hôpital de l'Archet 2
city: Paris
country: France
facility: Hôpital Saint Louis
city: Rouen
country: France
facility: CHU Rouen - Hôpital des enfants
city: Saint-Étienne
country: France
facility: CHU Saint Etienne Hôpital Nord
city: Toulouse
country: France
facility: Institut Universitaire du Cancer
city: Tours
country: France
facility: Hôpital BRETONNEAU
city: Vandœuvre-lès-Nancy
country: France
facility: Hôpital Brabois Enfants
Study officials:
affiliation: IHOP, Lyon
name: Pr. Yves BERTRAND
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Saint Louis Paris
name: Pr. Hervé DOMBRET
role: PRINCIPAL_INVESTIGATOR
References: