Phase 2
N=30
Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Elderly Patients With First Line Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01523782 ↗Enrolled (actual)
30
Serious AEs
96.7%
Results posted
Jun 2018
Primary outcome: Primary: Efficacy Primary Endpoint - Percentage of Patients Responding to Treatment — 0; 11; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GRASPA (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- ERYtech Pharma
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Primary Endpoint - Percentage of Patients Responding to Treatment |
0; 11; 10 | — |
| PRIMARY Safety Endpoint - DLTs Assessed During Induction 1 and Induction 2 |
0; 5; 17 | — |
| SECONDARY Plasma Concentrations of Asparagine |
60.86; 46.74; 42.33; 0.51; 0.51; 0.51 | — |
| SECONDARY Plasma Concentrations of Aspartic Acid |
1.91; 2.38; 3.59; 11.08; 5.22; 8.11 | — |
| SECONDARY Plasma Concentrations of Glutamine |
558.78; 484.19; 432.07; 616.13; 494.76; 463.03 | — |
| SECONDARY Plasma Concentrations of Glutamic Acid. |
49.96; 28.68; 39.87; 94.73; 54.38; 52.17 | — |
| SECONDARY Cerebral Spinal Fluid Concentrations of Asparagine |
5.98; 8.35; 6.06; 6.57; 1.47; 1.61 | — |
| SECONDARY Cerebral Spinal Fluid Concentrations of Aspartic Acid |
.95; .95; .95; .95; 1.04; 1.10 | — |
| SECONDARY Cerebral Spinal Fluid Concentrations of Glutamine |
270.57; 441.34; 408.56; 395.76; 363.40; 360.57 | — |
| SECONDARY Cerebral Spinal Fluid Concentrations of Glutamic Acid |
91.55; 91.98; 61.48; 132.53; 71.78; 43.93 | — |
| SECONDARY Summary of Free Asparaginase Over Time |
3.33; 3.38; 3.33; 2.21; 6.87; 4.96 | — |
| SECONDARY Summary of Encapsulated Asparaginase (U/L) Over Time |
72.50; 239.49; 72.50; 915.32; 1308.48; 1795.03 | — |
| SECONDARY Number of Patients Positive for Anti-L-asparaginase Antibodies |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Complete Remission (CR) Rate Following Induction 1 and Induction 2 |
2; 10; 8; 2; 10; 7 | — |
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-).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01523782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.