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
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
1 other identifier
expanded_access
N/A
1 country
10
Brief Summary
Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase.
Trial Health
Trial Health Score
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10 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2014
CompletedFirst Posted
Study publicly available on registry
July 23, 2014
CompletedDecember 4, 2018
November 1, 2018
May 7, 2014
November 30, 2018
Conditions
Keywords
Interventions
Erythrocytes encapsulating L-asparaginase
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ERYtech Pharmalead
Study Sites (10)
Hôpital Jean Minjoz - Batiment MEMCP
Besançon, 25030, France
CHRU Lille - Hôpital Claude-Huriez
Lille, 59037, France
IHOP
Lyon, 69373, France
Hôpital de l'Archet 2
Nice, 06202, France
Hôpital Saint Louis
Paris, 75475, France
CHU Rouen - Hôpital des enfants
Rouen, 76031, France
CHU Saint Etienne Hôpital Nord
Saint-Etienne, 42055, France
Institut Universitaire du Cancer
Toulouse, 31100, France
Hôpital BRETONNEAU
Tours, 37044, France
Hôpital Brabois Enfants
Vandœuvre-lès-Nancy, 54511, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pr. Yves BERTRAND
IHOP, Lyon
- PRINCIPAL INVESTIGATOR
Pr. Hervé DOMBRET
Hôpital Saint Louis Paris
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2014
First Posted
July 23, 2014
Last Updated
December 4, 2018
Record last verified: 2018-11