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Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Elderly Patients With First Line Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ERYtech Pharma
ClinicalTrials.gov Identifier:
NCT01523782
First received: January 16, 2012
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
  Purpose

There is not clinical validation that the benefits of L-asparaginase can offers during induction chemotherapy for elderly patients, where prevent toxicities is critical.This Phase IIa clinical trial propose to evaluate, specifically for elderly patients, the tolerated dose of GRASPA® in combination with a poly chemotherapy treatment which enables efficient L-asparagine depletion for a period at least equal to 7 days.


Condition Intervention Phase
Acute Lymphoblastic Leukemia
 Drug: GRASPA
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Escalating Dose Phase IIa Study of L-Asparaginase Encapsulated in Erythrocytes (GRASPA®) in Association With Polychemotherapy During Induction Phase for Treatment of Elderly Patients With Acute Lymphoblastic Leukaemia (ALL), Aged 55 Years and Over, With Philadelphia Chromosome-negative (ALL Ph-)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ERYtech Pharma:

Primary Outcome Measures:
  • efficacy and toxicity combined [ Time Frame: End of induction (2 months) ] [ Designated as safety issue: Yes ]

    The main evaluation criterion is a composite efficacy/toxicity criterion

    • Efficacy:Percentage of patients responding to treatment i.e. patients with blood levels of plasma asparagine ≤ 2µM over a period of at least 7 days after the administration of GRASPA®.
    • Toxicity:Grade 2,3 or 4 pancreatic toxicity, hepatic toxicity, allergy / Grade 3 or 4 deep cerebral thrombosis / Haematological toxicity /Any other grade 4 toxicity


Secondary Outcome Measures:
  • Serum concentrations of asparagine,aspartate,glutamine, glutamate and asparaginase. [ Time Frame: 0, 1, 7, 14, 28 days post-dose ] [ Designated as safety issue: No ]
  • Immunogenicity: evaluation of the titer of the anti-asparaginase antibody [ Time Frame: 0,1, 28 days post-dose ] [ Designated as safety issue: No ]
  • Percentage of haematological Complete Remission after each induction phase [ Time Frame: 1 and 2 months ] [ Designated as safety issue: No ]
  • Cerebral Spinal Fluid concentrations of asparagine,aspartate,glutamine, glutamate [ Time Frame: 0,6 days post-dose ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Event Free Survival [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Disease Free Survival [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2009
Study Completion Date: October 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GRASPA 50 IU/kg
Each patient will receive GRASPA 50 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase.
 Drug: GRASPA
Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Experimental: GRASPA 100 IU/kg
Each patient will receive GRASPA 100 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
 Drug: GRASPA
Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
Experimental: GRASPA 150
Each patient will receive GRASPA 150 IU/kg at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
 Drug: GRASPA
Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged ≥ 55 years
  • Newly diagnosed ALL without prior treatment
  • Patient capable to receive polychemotherapy (WHO < 2)
  • With or without meningeal disease
  • Signed Informed Consent Forms
  • Subscribed to social security insurance

Exclusion Criteria:

  • ALL t(9;22) and/or BCR-ABL positive
  • General state incompatible with chemotherapy treatment (WHO>2)
  • Presenting with a general or visceral contraindication to intensive treatment
  • Patient with another cancer other than ALL
  • Severe evolutive infection, or, HIV seropositive or, active hepatitis related to B or C viral infection
  • Prior treatment with L-asparaginase (irrespective of the form)
  • History of Grade 3 Transfusional incident (life threatening)
  • Presenting rare and/or dangerous anti-erythrocyte antibodies thus leading to the unavailable of a phenotype compatible Red Blood Cells
  • Included in another clinical trial during the last 4weeks.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: ERYtech Pharma
ClinicalTrials.gov Identifier: NCT01523782     History of Changes
Other Study ID Numbers: GRASPALL/GRAALLSA2-2008
Study First Received: January 16, 2012
Last Updated: March 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by ERYtech Pharma:
Acute Lymphoblastic leukemia
Elderly patient
Asparaginase

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

ClinicalTrials.gov processed this record on May 16, 2013