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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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-).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ERYtech Pharma
• Treatments: Asparaginase

Criteria

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