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

• Conditions: Acute Lymphoblastic Leukemia

• Registration Number: NCT02197650
• Lead Sponsor: ERYtech Pharma

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.

Study Timeline

• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-23
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-30
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (10)

IHOP; 🇫🇷 Lyon, France

CHRU Lille - Hôpital Claude-Huriez; 🇫🇷 Lille, France

Institut Universitaire du Cancer; 🇫🇷 Toulouse, France

Hôpital BRETONNEAU; 🇫🇷 Tours, France

Hôpital Brabois Enfants; 🇫🇷 Vandœuvre-lès-Nancy, France

Hôpital de l'Archet 2; 🇫🇷 Nice, France

CHU Saint Etienne Hôpital Nord; 🇫🇷 Saint-Étienne, France

Hôpital Saint Louis; 🇫🇷 Paris, France

Hôpital Jean Minjoz - Batiment MEMCP; 🇫🇷 Besançon, France

CHU Rouen - Hôpital des enfants; 🇫🇷 Rouen, France