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 (EAP)

ERYtech Pharma

Status

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: suspension of erythrocytes encapsulating L-asparaginase

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT02197650

GRASPALL 2012-10-EAP

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: Under 55 years old

Volunteers: No Healthy Volunteers

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