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)

November 30, 2018 updated by: ERYtech Pharma

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

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

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

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 Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • Hôpital Jean Minjoz - Batiment MEMCP
      • Lille, France, 59037
        • CHRU Lille - Hôpital Claude-Huriez
      • Lyon, France, 69373
        • IHOP
      • Nice, France, 06202
        • Hopital de l'Archet 2
      • Paris, France, 75475
        • Hopital Saint Louis
      • Rouen, France, 76031
        • CHU Rouen - Hôpital des enfants
      • Saint-Étienne, France, 42055
        • CHU Saint Etienne Hopital Nord
      • Toulouse, France, 31100
        • Institut universitaire du cancer
      • Tours, France, 37044
        • Hopital Bretonneau
      • Vandœuvre-lès-Nancy, France, 54511
        • Hôpital Brabois Enfants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 55 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ERYtech Pharma

Investigators

  • Principal Investigator: Pr. Yves BERTRAND, IHOP, Lyon
  • Principal Investigator: Pr. Hervé DOMBRET, Hôpital Saint Louis Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 7, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 23, 2014

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

November 30, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRASPALL 2012-10-EAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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