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

E

ERYtech Pharma

Status and phase

Completed
Phase 2

Conditions

Acute Lymphoblastic Leukemia

Treatments

Drug: GRASPA

Study type

Interventional

Funder types

Industry

Identifiers

NCT01523782
GRASPALL/GRAALLSA2-2008

Details and patient eligibility

About

The main purpose of this study is to determine the maximum tolerated and efficient dose of GRASPA® in combination with polychemotherapy treatment of elderly patients with ALL, 55 years and over, Philadelphia chromosome-negative (ALL Ph-).

Full description

This open label, non randomised, multicentric and national phase IIa study was designed to evaluate the safety and efficacy of GRASPA®, a suspension of red blood cells encapsulating E. Coli L-asparaginase, at different doses and in combination with the polychemotherapy regimen recommended by the European Working Group on Adult ALL (EWALL) for frontline therapy of patients with ALL Ph-, aged 55 years old and over. Patients with a good performance status (WHO score ≤2) and a newly diagnosed ALL Ph- were treated with the backbone polychemotherapy consisting of a first 4-week induction phase comprising dexamethasone, vincristine and idarubicin, a second 4-week induction phase including cyclophosphamide, cytarabine, a 6-month consolidation phase consisting of 6 alternating cycles with methotrexate, asparaginase and folinic acid (cycles 1, 3 and 5) and high-dose cytarabine (cycles 2, 4 and 6) with Granulocyte colony stimulating factor (G-CSF) support followed by a 16-month maintenance period with mercaptopurine, methotrexate and vincristine/dexamethasone pulses. GRASPA® was administered on day 3 of induction 1 and on day 6 of induction 2 of the chemotherapy regimen.

Enrollment

30 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient aged ≥55 years old
  • With newly diagnosed ALL without prior treatment
  • Capable to receive polychemotherapy (World Health Organization (WHO) performance status ≤2)
  • With or without meningeal disease
  • Having signed an Informed Consent Form
  • Subscribed to social security insurance

Exclusion criteria

  • ALL translocation(9;22) and/or BCR-ABL (Breakpoint Cluster Region-Abelson) positive

  • Performance status incompatible with chemotherapy treatment (WHO score >2)

  • Patient presenting with a general or visceral contraindication to intensive treatment including :

    • Cardiac insufficiency defined as Left Ventricular Ejection Fraction <50% of the theoretical value
    • Plasma creatinine concentration 2 times greater than the upper limit of laboratory ranges, except if related to ALL
    • Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) levels 5 times greater than the upper limit of laboratory ranges, except if related to ALL
    • Patient with another evolutive cancer other than ALL
    • Severe evolutive infection, or Human Immunodeficiency Virus (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)

  • Patient presenting rare and/or dangerous anti-erythrocyte antibodies thus leading to the unavailability of phenotype compatible Red Blood Cells Concentrate

  • Patient included in another clinical trial during the last 4 weeks

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 3 patient groups

GRASPA 50 IU/kg
Experimental group
Description:
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.
Treatment:
Drug: GRASPA
GRASPA 100 IU/kg
Experimental group
Description:
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
Treatment:
Drug: GRASPA
GRASPA 150 IU/kg
Experimental group
Description:
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
Treatment:
Drug: GRASPA

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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