Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Patients (Adults/Children) With Relapse of Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ERYtech Pharma
ClinicalTrials.gov Identifier:
NCT01518517
First received: January 10, 2012
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

This study is run to confirm the benefit/risk profile of GRASPA® at 150 IU/kg in combination with the COOPRALL regimen in adults and children patients with relapsed ALL, with or without known hypersensitivity to L-asparaginase.


Condition Intervention Phase
Acute Lymphoblastic Leukemia, in Relapse
Drug: GRASPA
Drug: L-asparaginase
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2/3 Study Evaluating Efficacy and Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA)Versus Reference L-asparaginase Treatment in Combination With Standard Polychemotherapy in Patient With First Recurrence of Philadelphia Negative Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by ERYtech Pharma:

Primary Outcome Measures:
  • efficacy and toxicity combined [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    efficacy assessed according mean duration of asparaginase depletion / toxicity assessed according incidence of allergic reaction whatever the grade


Secondary Outcome Measures:
  • Molecular response rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Plasma concentration of asparagine, aspartate, glutamine, glutamate and asparaginase [ Time Frame: 0,1,3,6, 9 days post-dose ] [ Designated as safety issue: No ]
  • Specific anti L-asparaginase antibodies [ Time Frame: 0,10 days post-dose ] [ Designated as safety issue: No ]
  • Event free survival [ Time Frame: 6 and 12 month ] [ Designated as safety issue: No ]
  • Relapse free survival [ Time Frame: 6 and 12 month ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 6 and 12 month ] [ Designated as safety issue: No ]
  • Percentage of patient with complete remission [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: December 2009
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GRASPA Drug: GRASPA
one injection of GRASPA 150 IU/kg at each cycle of chemotherapy
Active Comparator: reference L-asparaginase Drug: L-asparaginase
3 to 4 Injections of Native E.coli asparaginase 10000IU/m² (every 3 days) at each cycle of chemotherapy

  Eligibility

Ages Eligible for Study:   1 Year to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient from 1 to 55 years old (Children and adolescents from 1 to 17 years/ Adults from 18 to 55 years)
  • Patients with 1st ALL relapse, which could be either isolated bone marrow relapse, or combined (medullary and extra-medullary) relapse, or extra-medullary isolated CNS relapse; or lymphoblastic lymphoma (excepted Burkitt lymphoma) OR Failure to ALL first line treatment (no complete remission obtained)
  • Patient previously treated with free E.Coli L-asparaginase form or pegylated one
  • Performance Status ≤ 2 (WHO score)
  • Patient informed and consent provided (the 2 parents need to consent when children are below 18)

Exclusion Criteria:

  • ALL t(9;22) and/or BCR-ABL positive (Philadelphia chromosome positive)
  • Patient with 2nd relapse and over
  • Isolated extra-medullary relapse, excluding isolated CNS relapse
  • Women of childbearing potential without effective contraception as well as pregnant or breast feeding women
  • Patient unable to receive treatments used in global chemotherapy protocols, due to general or visceral conditions such as:Severe cardiac impairment (NYHA grade 3 or 4 cardiomyopathy)/Serum creatinine 2 x ULN unless related to ALL /ALT or AST 5 x ULN unless related to ALL /Pancreatitis history /Other malignancy that ALL / Severe Infection, HIV positive, active hepatitis related to B or C virus infection / Trisomy 21 / Other serious conditions according to investigator's opinion
  • Known grade 4 allergic reaction to E.Coli L-asparaginase (according NCI-CTCAE, Version 3.0)
  • History of grade 3 transfusional incident
  • Presence of specific anti-erythrocyte antibodies preventing from getting a compatible erythrocyte concentrate for the patient
  • Patient under concomitant treatment likely to cause hemolysis
  • Patient undergoing yellow fever vaccination
  • Patient under phenytoin treatment
  • Patient included in previous clinical study less than 6 weeks ago
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518517

Locations
Belgium
Hopital Des Enfants Reine Fabiola
Bruxelles, Belgium
Chr de La Citadelle
Liege, Belgium
France
Chu D'Angers
Angers, France
Hopital Saint Jacques
Besancon, France
Hopital Pellegrin Enfants
Bordeaux, France
Chu Estaing
Clermont Ferrand, France
Hopital Henri Mondor
Creteil, France
Chu Grenoble
Grenoble, France
Chru Lille - Hop Jeanne de Flandres
Lille, France
Institut Hematologie Oncologie Pediatrique
Lyon, France
Institut Paoli Calmettes
Marseille, France
Hotel Dieu
Nantes, France
Hopital Mere Enfant
Nantes, France
Hopital de L'Archet 2
Nice, France
Hopital Saint Louis
Paris, France
Hopital Armand Trousseau
Paris, France
Hopital Robert Debre
Paris, France
Hopital Haut-Leveque
Pessac, France
Hopital Lyon Sud
Pierre Benite, France
Chru Hopital Sud
Rennes, France
Centre Henri Becquerel
Rouen, France
Chu Hopital Nord
Saint Etienne, France
Institut Cancerologie de La Loire
Saint Priest En Jarez, France
Hopital de Hautepierre
Strasbourg, France
Chu de Toulouse Enfants
Toulouse, France
Hotel Dieu
Valenciennes, France
Hopital Brabois Enfants
Vandoeuvre Les Nancy, France
Hopital de Brabois
Vandoeuvre Les Nancy, France
Sponsors and Collaborators
ERYtech Pharma
Investigators
Principal Investigator: Yves Bertand, MD
  More Information

No publications provided

Responsible Party: ERYtech Pharma
ClinicalTrials.gov Identifier: NCT01518517     History of Changes
Other Study ID Numbers: GRASPALL2009-06
Study First Received: January 10, 2012
Last Updated: January 23, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by ERYtech Pharma:
acute lymphoblastic leukemia
relapse
asparaginase

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Asparaginase
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014