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

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ClinicalTrials.gov Identifier: NCT01523782
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: GRASPA Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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-)
Study Start Date : April 2009
Primary Completion Date : January 2011
Study Completion Date : October 2012


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. efficacy and toxicity combined [ Time Frame: End of induction (2 months) ]

    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 :
  1. Serum concentrations of asparagine,aspartate,glutamine, glutamate and asparaginase. [ Time Frame: 0, 1, 7, 14, 28 days post-dose ]
  2. Immunogenicity: evaluation of the titer of the anti-asparaginase antibody [ Time Frame: 0,1, 28 days post-dose ]
  3. Percentage of haematological Complete Remission after each induction phase [ Time Frame: 1 and 2 months ]
  4. Cerebral Spinal Fluid concentrations of asparagine,aspartate,glutamine, glutamate [ Time Frame: 0,6 days post-dose ]
  5. Overall Survival [ Time Frame: 6, 12 and 24 months ]
  6. Event Free Survival [ Time Frame: 6, 12 and 24 months ]
  7. Disease Free Survival [ Time Frame: 6, 12 and 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ERYtech Pharma
ClinicalTrials.gov Identifier: NCT01523782     History of Changes
Other Study ID Numbers: GRASPALL/GRAALLSA2-2008
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: March 8, 2013
Last Verified: March 2013

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

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