Acute Lymphoblastic Leukemia
Conditions
Keywords
Acute Lymphoblastic leukemia, Elderly patient, Asparaginase
Brief 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-).
Detailed 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.
Interventions
DRUGGRASPA
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
Sponsors
ERYtech Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Primary Endpoint - Percentage of Patients Responding to Treatment | 7 days after the first administration of GRASPA® during Induction 1 | The main evaluation criterion is a composite efficacy/toxicity criterion. Efficacy, assessed during induction 1: percentage of patients responding to treatment, i.e. with plasma Asn concentration ≤2µM (depleted), for a duration of at least 7 days after the administration of GRASPA® |
| Safety Endpoint - DLTs Assessed During Induction 1 and Induction 2 | Induction 1 and Induction 2 | Safety: Toxicity, assessed during Induction 1 and Induction 2: according to NCI-CTCAE v3.0 August 2006, with Dose Limiting Toxicities (DLT) defined as: Grade 2 to 4 pancreatic toxicity, Grade 3 or 4 hepatic toxicity, allergic toxicity or deep cerebral thrombosis, known as potentially related to L-asparaginase; hematological toxicity defined as bone marrow blast free aplasia, 30 days following the last injection of chemotherapy, all other Grade 4 toxicities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentrations of Glutamine | Induction 1 and Induction 2 | Mean glutamine concentration over time. |
| Plasma Concentrations of Glutamic Acid. | Induction 1 and Induction 2 | Mean glutamic acid concentration over time. |
| Cerebral Spinal Fluid Concentrations of Asparagine | Induction 1 and Induction 2 | Mean cerebral spinal fluid asparagine concentration over time. |
| Cerebral Spinal Fluid Concentrations of Aspartic Acid | Induction 1 and Induction 2 | Mean cerebral spinal fluid aspartic acid concentration |
| Cerebral Spinal Fluid Concentrations of Glutamine | Induction 1 and Induction 2 | Mean cerebral spinal fluid glutamine concentration |
| Plasma Concentrations of Asparagine | Induction 1 & Induction 2 | Mean plasma concentration of asparagine over time. Participants who were Below the Lower Limit of Quantification (BLLQ) were assigned a value of 0.51 μmol/L. |
| Summary of Free Asparaginase Over Time | Induction 1 and Induction 2 | — |
| Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1 and Induction 2 | — |
| Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 1 and Induction 2 | Evaluation of the number of patients testing positive for anti-asparaginase antibodies. |
| Number of Participants With Complete Remission (CR) Rate Following Induction 1 and Induction 2 | 1 and 2 months | CR was defined using: * Clinical criteria: disappearance of clinical signs of acute lymphocytic leukemia (ALL) * Blood criteria: neutrophils \> 1 G/L and platelets \>100 G/L * Medullary criteria: normally rich bone marrow and percentage of blasts \<5% |
| Cerebral Spinal Fluid Concentrations of Glutamic Acid | Induction 1 and Induction 2 | Mean cerebral spinal fluid glutamic acid concentration |
| Plasma Concentrations of Aspartic Acid | Induction 1 and Induction 2 | Mean plasma concentration of aspartic acid over time. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 3 |
| 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
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 | 13 |
| GRASPA 150 IU/kg 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
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 | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | GRASPA 50 IU/kg | GRASPA 100 IU/kg | GRASPA 150 IU/kg | Total |
|---|---|---|---|---|
| Age, Continuous | 68.33 years | 66.92 years | 67.00 years | 67.10 years |
| Region of Enrollment France | 3 participants | 13 participants | 14 participants | 30 participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 1 Participants | 7 Participants | 6 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 3 | 2 / 13 | 3 / 14 |
| other Total, other adverse events | 3 / 3 | 13 / 13 | 14 / 14 |
| serious Total, serious adverse events | 3 / 3 | 13 / 13 | 13 / 14 |
Outcome results
Primary
Efficacy Primary Endpoint - Percentage of Patients Responding to Treatment
The main evaluation criterion is a composite efficacy/toxicity criterion. Efficacy, assessed during induction 1: percentage of patients responding to treatment, i.e. with plasma Asn concentration ≤2µM (depleted), for a duration of at least 7 days after the administration of GRASPA®
Time frame: 7 days after the first administration of GRASPA® during Induction 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GRASPA 50 IU/kg | Efficacy Primary Endpoint - Percentage of Patients Responding to Treatment | 0 Participants |
| GRASPA 100 IU/kg | Efficacy Primary Endpoint - Percentage of Patients Responding to Treatment | 11 Participants |
| GRASPA 150 IU/kg | Efficacy Primary Endpoint - Percentage of Patients Responding to Treatment | 10 Participants |
Primary
Safety Endpoint - DLTs Assessed During Induction 1 and Induction 2
Safety: Toxicity, assessed during Induction 1 and Induction 2: according to NCI-CTCAE v3.0 August 2006, with Dose Limiting Toxicities (DLT) defined as: Grade 2 to 4 pancreatic toxicity, Grade 3 or 4 hepatic toxicity, allergic toxicity or deep cerebral thrombosis, known as potentially related to L-asparaginase; hematological toxicity defined as bone marrow blast free aplasia, 30 days following the last injection of chemotherapy, all other Grade 4 toxicities.
Time frame: Induction 1 and Induction 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GRASPA 50 IU/kg | Safety Endpoint - DLTs Assessed During Induction 1 and Induction 2 | 0 DLTs |
| GRASPA 100 IU/kg | Safety Endpoint - DLTs Assessed During Induction 1 and Induction 2 | 5 DLTs |
| GRASPA 150 IU/kg | Safety Endpoint - DLTs Assessed During Induction 1 and Induction 2 | 17 DLTs |
Secondary
Cerebral Spinal Fluid Concentrations of Asparagine
Mean cerebral spinal fluid asparagine concentration over time.
Time frame: Induction 1 and Induction 2
Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Asparagine | Induction 1, D2 | 5.98 μmol/L | Standard Deviation 0.63 |
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Asparagine | Induction 1, D9 | 6.57 μmol/L | Standard Deviation 2.72 |
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Asparagine | Induction 2, D2 | 6.24 μmol/L | Standard Deviation 1.07 |
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Asparagine | Induction 2, D9 | 5.09 μmol/L | Standard Deviation 2.99 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Asparagine | Induction 2, D9 | 2.74 μmol/L | Standard Deviation 4.24 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Asparagine | Induction 1, D2 | 8.35 μmol/L | Standard Deviation 3.2 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Asparagine | Induction 2, D2 | 6.42 μmol/L | Standard Deviation 2.62 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Asparagine | Induction 1, D9 | 1.47 μmol/L | Standard Deviation 1.28 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Asparagine | Induction 2, D9 | 0.52 μmol/L | Standard Deviation 0.03 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Asparagine | Induction 1, D9 | 1.61 μmol/L | Standard Deviation 1.09 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Asparagine | Induction 2, D2 | 7.59 μmol/L | Standard Deviation 5.58 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Asparagine | Induction 1, D2 | 6.06 μmol/L | Standard Deviation 3.17 |
Secondary
Cerebral Spinal Fluid Concentrations of Aspartic Acid
Mean cerebral spinal fluid aspartic acid concentration
Time frame: Induction 1 and Induction 2
Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Aspartic Acid | Induction 1, D2 | .95 μmol/L | Standard Deviation 0 |
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Aspartic Acid | Induction 1, D9 | .95 μmol/L | Standard Deviation 0 |
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Aspartic Acid | Induction 2, D2 | .95 μmol/L | Standard Deviation 0 |
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Aspartic Acid | Induction 2, D9 | .95 μmol/L | Standard Deviation 0 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Aspartic Acid | Induction 2, D9 | 1.09 μmol/L | Standard Deviation 0.26 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Aspartic Acid | Induction 1, D2 | .95 μmol/L | Standard Deviation 0 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Aspartic Acid | Induction 2, D2 | .95 μmol/L | Standard Deviation 0 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Aspartic Acid | Induction 1, D9 | 1.04 μmol/L | Standard Deviation 0.32 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Aspartic Acid | Induction 2, D9 | .95 μmol/L | Standard Deviation 0 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Aspartic Acid | Induction 1, D9 | 1.10 μmol/L | Standard Deviation 0.46 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Aspartic Acid | Induction 2, D2 | 1.35 μmol/L | Standard Deviation 0.98 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Aspartic Acid | Induction 1, D2 | .95 μmol/L | Standard Deviation 0.01 |
Secondary
Cerebral Spinal Fluid Concentrations of Glutamic Acid
Mean cerebral spinal fluid glutamic acid concentration
Time frame: Induction 1 and Induction 2
Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamic Acid | Induction 1, D2 | 91.55 μmol/L | Standard Deviation 39.44 |
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamic Acid | Induction 1, D9 | 132.53 μmol/L | Standard Deviation 15.09 |
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamic Acid | Induction 2, D2 | 69.35 μmol/L | Standard Deviation 5.7 |
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamic Acid | Induction 2, D9 | 62.04 μmol/L | Standard Deviation 8.37 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamic Acid | Induction 2, D9 | 60.30 μmol/L | Standard Deviation 28.32 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamic Acid | Induction 1, D2 | 91.98 μmol/L | Standard Deviation 85 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamic Acid | Induction 2, D2 | 52.89 μmol/L | Standard Deviation 24.63 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamic Acid | Induction 1, D9 | 71.78 μmol/L | Standard Deviation 38.44 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamic Acid | Induction 2, D9 | 47.02 μmol/L | Standard Deviation 39.12 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamic Acid | Induction 1, D9 | 43.93 μmol/L | Standard Deviation 30.53 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamic Acid | Induction 2, D2 | 41.24 μmol/L | Standard Deviation 20.18 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamic Acid | Induction 1, D2 | 61.48 μmol/L | Standard Deviation 53.96 |
Secondary
Cerebral Spinal Fluid Concentrations of Glutamine
Mean cerebral spinal fluid glutamine concentration
Time frame: Induction 1 and Induction 2
Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamine | Induction 1, D2 | 270.57 μmol/L | Standard Deviation 108.21 |
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamine | Induction 1, D9 | 395.76 μmol/L | Standard Deviation 32.5 |
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamine | Induction 2, D2 | 345.41 μmol/L | Standard Deviation 4.13 |
| GRASPA 50 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamine | Induction 2, D9 | 372.56 μmol/L | Standard Deviation 15.67 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamine | Induction 2, D9 | 420.96 μmol/L | Standard Deviation 93.42 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamine | Induction 1, D2 | 441.34 μmol/L | Standard Deviation 239.5 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamine | Induction 2, D2 | 358.90 μmol/L | Standard Deviation 107.03 |
| GRASPA 100 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamine | Induction 1, D9 | 363.40 μmol/L | Standard Deviation 142.12 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamine | Induction 2, D9 | 351.30 μmol/L | Standard Deviation 44.86 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamine | Induction 1, D9 | 360.57 μmol/L | Standard Deviation 99.56 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamine | Induction 2, D2 | 378.14 μmol/L | Standard Deviation 70.19 |
| GRASPA 150 IU/kg | Cerebral Spinal Fluid Concentrations of Glutamine | Induction 1, D2 | 408.56 μmol/L | Standard Deviation 116.84 |
Secondary
Number of Participants With Complete Remission (CR) Rate Following Induction 1 and Induction 2
CR was defined using: * Clinical criteria: disappearance of clinical signs of acute lymphocytic leukemia (ALL) * Blood criteria: neutrophils \> 1 G/L and platelets \>100 G/L * Medullary criteria: normally rich bone marrow and percentage of blasts \<5%
Time frame: 1 and 2 months
Population: 28 patients were analyzed for CR after Induction 1 (2 pts in 50 IU/kg; 13 pts in 100 IU/kg; 13 pts in 150 IU/kg). 22 patients were analyzed for CR after Induction 2 (2 pts in 50 IU/kg; 11 pts in 100 IU/kg; 9 pts in 150 IU/kg).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GRASPA 50 IU/kg | Number of Participants With Complete Remission (CR) Rate Following Induction 1 and Induction 2 | Participants who met CR criteria at Induction 1 | 2 Participants |
| GRASPA 50 IU/kg | Number of Participants With Complete Remission (CR) Rate Following Induction 1 and Induction 2 | Participants who met CR criteria at Induction 2 | 2 Participants |
| GRASPA 100 IU/kg | Number of Participants With Complete Remission (CR) Rate Following Induction 1 and Induction 2 | Participants who met CR criteria at Induction 1 | 10 Participants |
| GRASPA 100 IU/kg | Number of Participants With Complete Remission (CR) Rate Following Induction 1 and Induction 2 | Participants who met CR criteria at Induction 2 | 10 Participants |
| GRASPA 150 IU/kg | Number of Participants With Complete Remission (CR) Rate Following Induction 1 and Induction 2 | Participants who met CR criteria at Induction 1 | 8 Participants |
| GRASPA 150 IU/kg | Number of Participants With Complete Remission (CR) Rate Following Induction 1 and Induction 2 | Participants who met CR criteria at Induction 2 | 7 Participants |
Secondary
Number of Patients Positive for Anti-L-asparaginase Antibodies
Evaluation of the number of patients testing positive for anti-asparaginase antibodies.
Time frame: Induction 1 and Induction 2
Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GRASPA 50 IU/kg | Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 2, D6 | 0 Participants |
| GRASPA 50 IU/kg | Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 1, D22-28 | 0 Participants |
| GRASPA 50 IU/kg | Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 1, D3 | 0 Participants |
| GRASPA 50 IU/kg | Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 1, D4 | 0 Participants |
| GRASPA 50 IU/kg | Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 2, D22-28 | 1 Participants |
| GRASPA 100 IU/kg | Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 1, D22-28 | 1 Participants |
| GRASPA 100 IU/kg | Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 1, D3 | 0 Participants |
| GRASPA 100 IU/kg | Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 1, D4 | 0 Participants |
| GRASPA 100 IU/kg | Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 2, D6 | 0 Participants |
| GRASPA 100 IU/kg | Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 2, D22-28 | 4 Participants |
| GRASPA 150 IU/kg | Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 2, D22-28 | 5 Participants |
| GRASPA 150 IU/kg | Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 2, D6 | 1 Participants |
| GRASPA 150 IU/kg | Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 1, D3 | 0 Participants |
| GRASPA 150 IU/kg | Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 1, D22-28 | 1 Participants |
| GRASPA 150 IU/kg | Number of Patients Positive for Anti-L-asparaginase Antibodies | Induction 1, D4 | 0 Participants |
Secondary
Plasma Concentrations of Asparagine
Mean plasma concentration of asparagine over time. Participants who were Below the Lower Limit of Quantification (BLLQ) were assigned a value of 0.51 μmol/L.
Time frame: Induction 1 & Induction 2
Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GRASPA 50 IU/kg | Plasma Concentrations of Asparagine | Induction 1, Day 3 | 60.86 μmol/L | Standard Deviation 9.38 |
| GRASPA 50 IU/kg | Plasma Concentrations of Asparagine | Induction 1, Day 4 | 0.51 μmol/L | Standard Deviation 0 |
| GRASPA 50 IU/kg | Plasma Concentrations of Asparagine | Induction 1, Day 10 | 17.48 μmol/L | Standard Deviation 11.46 |
| GRASPA 50 IU/kg | Plasma Concentrations of Asparagine | Induction 1, Day 17 | 16.33 μmol/L | Standard Deviation 9.62 |
| GRASPA 50 IU/kg | Plasma Concentrations of Asparagine | Induction 1, Day 22-28 | 24.55 μmol/L | Standard Deviation 1.6 |
| GRASPA 50 IU/kg | Plasma Concentrations of Asparagine | Induction 2, Day 6 | 45.39 μmol/L | Standard Deviation 1.24 |
| GRASPA 50 IU/kg | Plasma Concentrations of Asparagine | Induction 2, Day 7 | 9.41 μmol/L | Standard Deviation 12.59 |
| GRASPA 50 IU/kg | Plasma Concentrations of Asparagine | Induction 2, Day 13 | 29.47 μmol/L | Standard Deviation 34.69 |
| GRASPA 50 IU/kg | Plasma Concentrations of Asparagine | Induction 2, Day 20 | 34.20 μmol/L | Standard Deviation 8.48 |
| GRASPA 50 IU/kg | Plasma Concentrations of Asparagine | Induction 2, Day 22 to D28 | 46.22 μmol/L | Standard Deviation 28.92 |
| GRASPA 100 IU/kg | Plasma Concentrations of Asparagine | Induction 2, Day 20 | 13.71 μmol/L | Standard Deviation 10.4 |
| GRASPA 100 IU/kg | Plasma Concentrations of Asparagine | Induction 1, Day 3 | 46.74 μmol/L | Standard Deviation 21.44 |
| GRASPA 100 IU/kg | Plasma Concentrations of Asparagine | Induction 2, Day 6 | 28.11 μmol/L | Standard Deviation 9.74 |
| GRASPA 100 IU/kg | Plasma Concentrations of Asparagine | Induction 1, Day 22-28 | 20.35 μmol/L | Standard Deviation 10.6 |
| GRASPA 100 IU/kg | Plasma Concentrations of Asparagine | Induction 1, Day 4 | 0.51 μmol/L | Standard Deviation 0 |
| GRASPA 100 IU/kg | Plasma Concentrations of Asparagine | Induction 2, Day 22 to D28 | 17.27 μmol/L | Standard Deviation 12.12 |
| GRASPA 100 IU/kg | Plasma Concentrations of Asparagine | Induction 2, Day 13 | 10.37 μmol/L | Standard Deviation 11.16 |
| GRASPA 100 IU/kg | Plasma Concentrations of Asparagine | Induction 1, Day 10 | 1.78 μmol/L | Standard Deviation 3.39 |
| GRASPA 100 IU/kg | Plasma Concentrations of Asparagine | Induction 2, Day 7 | 9.44 μmol/L | Standard Deviation 16.23 |
| GRASPA 100 IU/kg | Plasma Concentrations of Asparagine | Induction 1, Day 17 | 10.05 μmol/L | Standard Deviation 8.1 |
| GRASPA 150 IU/kg | Plasma Concentrations of Asparagine | Induction 2, Day 13 | 3.79 μmol/L | Standard Deviation 6.58 |
| GRASPA 150 IU/kg | Plasma Concentrations of Asparagine | Induction 1, Day 17 | 9.30 μmol/L | Standard Deviation 7.39 |
| GRASPA 150 IU/kg | Plasma Concentrations of Asparagine | Induction 1, Day 22-28 | 18.76 μmol/L | Standard Deviation 8.74 |
| GRASPA 150 IU/kg | Plasma Concentrations of Asparagine | Induction 2, Day 6 | 27.16 μmol/L | Standard Deviation 14.45 |
| GRASPA 150 IU/kg | Plasma Concentrations of Asparagine | Induction 2, Day 20 | 12.91 μmol/L | Standard Deviation 8.17 |
| GRASPA 150 IU/kg | Plasma Concentrations of Asparagine | Induction 2, Day 7 | 0.51 μmol/L | Standard Deviation 0 |
| GRASPA 150 IU/kg | Plasma Concentrations of Asparagine | Induction 1, Day 3 | 42.33 μmol/L | Standard Deviation 10.98 |
| GRASPA 150 IU/kg | Plasma Concentrations of Asparagine | Induction 2, Day 22 to D28 | 17.23 μmol/L | Standard Deviation 4.77 |
| GRASPA 150 IU/kg | Plasma Concentrations of Asparagine | Induction 1, Day 4 | 0.51 μmol/L | Standard Deviation 0 |
| GRASPA 150 IU/kg | Plasma Concentrations of Asparagine | Induction 1, Day 10 | 3.11 μmol/L | Standard Deviation 4.05 |
Secondary
Plasma Concentrations of Aspartic Acid
Mean plasma concentration of aspartic acid over time.
Time frame: Induction 1 and Induction 2
Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GRASPA 50 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 1, D3 | 1.91 μmol/L | Standard Deviation 0.28 |
| GRASPA 50 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 1, D4 | 11.08 μmol/L | Standard Deviation 4.14 |
| GRASPA 50 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 1, D10 | 17.93 μmol/L | Standard Deviation 3.65 |
| GRASPA 50 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 1, D17 | 3.76 μmol/L | Standard Deviation 1.39 |
| GRASPA 50 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 1, D22-28 | 5.17 μmol/L | Standard Deviation 1.82 |
| GRASPA 50 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 2, D6 | 2.32 μmol/L | Standard Deviation 0.63 |
| GRASPA 50 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 2, D7 | 12.06 μmol/L | Standard Deviation 6.36 |
| GRASPA 50 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 2, D13 | 9.07 μmol/L | Standard Deviation 8.92 |
| GRASPA 50 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 2, D20 | 2.56 μmol/L | Standard Deviation 0.37 |
| GRASPA 50 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 2, D22-28 | 3.37 μmol/L | Standard Deviation 1 |
| GRASPA 100 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 2, D20 | 8.39 μmol/L | Standard Deviation 6.58 |
| GRASPA 100 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 1, D3 | 2.38 μmol/L | Standard Deviation 4.39 |
| GRASPA 100 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 2, D6 | 4.17 μmol/L | Standard Deviation 4.31 |
| GRASPA 100 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 1, D22-28 | 10.27 μmol/L | Standard Deviation 9.88 |
| GRASPA 100 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 1, D4 | 5.22 μmol/L | Standard Deviation 1.81 |
| GRASPA 100 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 2, D22-28 | 11.04 μmol/L | Standard Deviation 8.66 |
| GRASPA 100 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 2, D13 | 9.82 μmol/L | Standard Deviation 6.52 |
| GRASPA 100 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 1, D10 | 16.47 μmol/L | Standard Deviation 6.17 |
| GRASPA 100 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 2, D7 | 6.35 μmol/L | Standard Deviation 3.67 |
| GRASPA 100 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 1, D17 | 10.60 μmol/L | Standard Deviation 6.02 |
| GRASPA 150 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 2, D13 | 10.07 μmol/L | Standard Deviation 5.19 |
| GRASPA 150 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 1, D17 | 8.43 μmol/L | Standard Deviation 4.58 |
| GRASPA 150 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 1, D22-28 | 6.93 μmol/L | Standard Deviation 5.31 |
| GRASPA 150 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 2, D6 | 5.08 μmol/L | Standard Deviation 3.35 |
| GRASPA 150 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 2, D20 | 7.06 μmol/L | Standard Deviation 5.28 |
| GRASPA 150 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 2, D7 | 7.59 μmol/L | Standard Deviation 3.45 |
| GRASPA 150 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 1, D3 | 3.59 μmol/L | Standard Deviation 5.03 |
| GRASPA 150 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 2, D22-28 | 6.32 μmol/L | Standard Deviation 4.75 |
| GRASPA 150 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 1, D4 | 8.11 μmol/L | Standard Deviation 5.5 |
| GRASPA 150 IU/kg | Plasma Concentrations of Aspartic Acid | Induction 1, D10 | 13.51 μmol/L | Standard Deviation 5.16 |
Secondary
Plasma Concentrations of Glutamic Acid.
Mean glutamic acid concentration over time.
Time frame: Induction 1 and Induction 2
Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 1, D3 | 49.96 μmol/L | Standard Deviation 17.23 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 1, D4 | 94.73 μmol/L | Standard Deviation 35.53 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 1, D10 | 53.58 μmol/L | Standard Deviation 6.94 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 1, D17 | 65.73 μmol/L | Standard Deviation 21.31 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 1, D22-28 | 42.83 μmol/L | Standard Deviation 2.56 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 2, D6 | 58.94 μmol/L | Standard Deviation 37.41 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 2, D7 | 77.11 μmol/L | Standard Deviation 29.37 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 2, D13 | 34.70 μmol/L | Standard Deviation 9.57 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 2, D20 | 27.83 μmol/L | Standard Deviation 7.63 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 2, D22-28 | 56.21 μmol/L | Standard Deviation 1.85 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 2, D20 | 42.86 μmol/L | Standard Deviation 20.7 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 1, D3 | 28.68 μmol/L | Standard Deviation 18.01 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 2, D6 | 53.88 μmol/L | Standard Deviation 29.03 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 1, D22-28 | 46.74 μmol/L | Standard Deviation 27.49 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 1, D4 | 54.38 μmol/L | Standard Deviation 29.68 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 2, D22-28 | 47.92 μmol/L | Standard Deviation 31.07 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 2, D13 | 53.64 μmol/L | Standard Deviation 27.7 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 1, D10 | 31.87 μmol/L | Standard Deviation 17.41 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 2, D7 | 63.51 μmol/L | Standard Deviation 35.37 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 1, D17 | 39.71 μmol/L | Standard Deviation 27.67 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 2, D13 | 52.24 μmol/L | Standard Deviation 23.91 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 1, D17 | 31.57 μmol/L | Standard Deviation 23.33 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 1, D22-28 | 36.49 μmol/L | Standard Deviation 22.9 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 2, D6 | 55.94 μmol/L | Standard Deviation 32.51 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 2, D20 | 35.09 μmol/L | Standard Deviation 14.87 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 2, D7 | 83.98 μmol/L | Standard Deviation 49.74 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 1, D3 | 39.87 μmol/L | Standard Deviation 49.71 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 2, D22-28 | 42.62 μmol/L | Standard Deviation 11.94 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 1, D4 | 52.17 μmol/L | Standard Deviation 29.01 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamic Acid. | Induction 1, D10 | 31.82 μmol/L | Standard Deviation 23.2 |
Secondary
Plasma Concentrations of Glutamine
Mean glutamine concentration over time.
Time frame: Induction 1 and Induction 2
Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamine | Induction 1, D3 | 558.78 μmol/L | Standard Deviation 158.02 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamine | Induction 1, D4 | 616.13 μmol/L | Standard Deviation 184.59 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamine | Induction 1, D10 | 576.86 μmol/L | Standard Deviation 172.51 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamine | Induction 1, D17 | 384.12 μmol/L | Standard Deviation 28.05 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamine | Induction 1, D22-28 | 394.53 μmol/L | Standard Deviation 21.5 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamine | Induction 2, D6 | 508.99 μmol/L | Standard Deviation 17.53 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamine | Induction 2, D7 | 553.63 μmol/L | Standard Deviation 71.15 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamine | Induction 2, D13 | 517.42 μmol/L | Standard Deviation 50.94 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamine | Induction 2, D20 | 436.17 μmol/L | Standard Deviation 15.72 |
| GRASPA 50 IU/kg | Plasma Concentrations of Glutamine | Induction 2, D22-28 | 530.40 μmol/L | Standard Deviation 167.13 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamine | Induction 2, D20 | 406.62 μmol/L | Standard Deviation 101.32 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamine | Induction 1, D3 | 484.19 μmol/L | Standard Deviation 137.05 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamine | Induction 2, D6 | 436.71 μmol/L | Standard Deviation 140.02 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamine | Induction 1, D22-28 | 422.76 μmol/L | Standard Deviation 175.67 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamine | Induction 1, D4 | 494.76 μmol/L | Standard Deviation 142.95 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamine | Induction 2, D22-28 | 504.97 μmol/L | Standard Deviation 117.83 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamine | Induction 2, D13 | 467.52 μmol/L | Standard Deviation 136.17 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamine | Induction 1, D10 | 521.86 μmol/L | Standard Deviation 180.41 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamine | Induction 2, D7 | 498.41 μmol/L | Standard Deviation 131.33 |
| GRASPA 100 IU/kg | Plasma Concentrations of Glutamine | Induction 1, D17 | 344.03 μmol/L | Standard Deviation 102.95 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamine | Induction 2, D13 | 456.52 μmol/L | Standard Deviation 113.75 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamine | Induction 1, D17 | 266.08 μmol/L | Standard Deviation 71.48 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamine | Induction 1, D22-28 | 393.87 μmol/L | Standard Deviation 78.01 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamine | Induction 2, D6 | 426.28 μmol/L | Standard Deviation 72.15 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamine | Induction 2, D20 | 394.51 μmol/L | Standard Deviation 69.15 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamine | Induction 2, D7 | 445.00 μmol/L | Standard Deviation 145.95 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamine | Induction 1, D3 | 432.07 μmol/L | Standard Deviation 69.93 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamine | Induction 2, D22-28 | 441.50 μmol/L | Standard Deviation 60.63 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamine | Induction 1, D4 | 463.03 μmol/L | Standard Deviation 117.79 |
| GRASPA 150 IU/kg | Plasma Concentrations of Glutamine | Induction 1, D10 | 447.07 μmol/L | Standard Deviation 159.93 |
Secondary
Summary of Encapsulated Asparaginase (U/L) Over Time
Time frame: Induction 1 and Induction 2
Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GRASPA 50 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 2, D7 | 722.57 U/L | Standard Deviation 120.11 |
| GRASPA 50 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1, D10 | 579.22 U/L | Standard Deviation 129.99 |
| GRASPA 50 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 2, D13 | 714.90 U/L | Standard Deviation 49.91 |
| GRASPA 50 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 2, D20 | 556.00 U/L | Standard Deviation 52.1 |
| GRASPA 50 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1, D3 | 72.50 U/L | Standard Deviation 0 |
| GRASPA 50 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 2, D22-28 | 509.20 U/L | Standard Deviation 0 |
| GRASPA 50 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1, D17 | 402.41 U/L | Standard Deviation 181.91 |
| GRASPA 50 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1, D4 | 915.32 U/L | Standard Deviation 137.09 |
| GRASPA 50 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1, D22-28 | 383.59 U/L | Standard Deviation 62.77 |
| GRASPA 50 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 2, D6 | 72.50 U/L | Standard Deviation 0 |
| GRASPA 100 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 2, D7 | 1223.20 U/L | Standard Deviation 323.83 |
| GRASPA 100 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1, D17 | 790.39 U/L | Standard Deviation 193.78 |
| GRASPA 100 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 2, D6 | 382.51 U/L | Standard Deviation 275 |
| GRASPA 100 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1, D10 | 1105.24 U/L | Standard Deviation 339.77 |
| GRASPA 100 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1, D3 | 239.49 U/L | Standard Deviation 602.11 |
| GRASPA 100 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 2, D20 | 745.22 U/L | Standard Deviation 288.06 |
| GRASPA 100 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1, D22-28 | 571.49 U/L | Standard Deviation 225.69 |
| GRASPA 100 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1, D4 | 1308.48 U/L | Standard Deviation 490.99 |
| GRASPA 100 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 2, D22-28 | 673.64 U/L | Standard Deviation 307.1 |
| GRASPA 100 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 2, D13 | 1051.64 U/L | Standard Deviation 285.32 |
| GRASPA 150 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 2, D22-28 | 813.98 U/L | Standard Deviation 240.88 |
| GRASPA 150 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1, D3 | 72.50 U/L | Standard Deviation 0 |
| GRASPA 150 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1, D4 | 1795.03 U/L | Standard Deviation 564.74 |
| GRASPA 150 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1, D10 | 1309.08 U/L | Standard Deviation 497.53 |
| GRASPA 150 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1, D17 | 793.97 U/L | Standard Deviation 291.67 |
| GRASPA 150 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 1, D22-28 | 629.35 U/L | Standard Deviation 253.6 |
| GRASPA 150 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 2, D6 | 524.37 U/L | Standard Deviation 164.72 |
| GRASPA 150 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 2, D7 | 1913.32 U/L | Standard Deviation 788.45 |
| GRASPA 150 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 2, D13 | 1536.06 U/L | Standard Deviation 401.09 |
| GRASPA 150 IU/kg | Summary of Encapsulated Asparaginase (U/L) Over Time | Induction 2, D20 | 1191.24 U/L | Standard Deviation 450.38 |
Secondary
Summary of Free Asparaginase Over Time
Time frame: Induction 1 and Induction 2
Population: The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GRASPA 50 IU/kg | Summary of Free Asparaginase Over Time | Induction 1, D17 | 0.73 U/L | Standard Deviation 0.38 |
| GRASPA 50 IU/kg | Summary of Free Asparaginase Over Time | Induction 1, D4 | 2.21 U/L | Standard Deviation 0.57 |
| GRASPA 50 IU/kg | Summary of Free Asparaginase Over Time | Induction 2, D6 | 3.33 U/L | Standard Deviation 0 |
| GRASPA 50 IU/kg | Summary of Free Asparaginase Over Time | Induction 2, D7 | 1.47 U/L | Standard Deviation 1.65 |
| GRASPA 50 IU/kg | Summary of Free Asparaginase Over Time | Induction 1, D22-28 | 0.66 U/L | Standard Deviation 0.11 |
| GRASPA 50 IU/kg | Summary of Free Asparaginase Over Time | Induction 1, D3 | 3.33 U/L | Standard Deviation 0 |
| GRASPA 50 IU/kg | Summary of Free Asparaginase Over Time | Induction 2, D20 | 0.45 U/L | Standard Deviation 0.04 |
| GRASPA 50 IU/kg | Summary of Free Asparaginase Over Time | Induction 1, D10 | 0.48 U/L | Standard Deviation 0.09 |
| GRASPA 50 IU/kg | Summary of Free Asparaginase Over Time | Induction 2, D22-28 | 0.49 U/L | Standard Deviation 0 |
| GRASPA 50 IU/kg | Summary of Free Asparaginase Over Time | Induction 2, D13 | 0.35 U/L | Standard Deviation 0.02 |
| GRASPA 100 IU/kg | Summary of Free Asparaginase Over Time | Induction 2, D7 | 3.50 U/L | Standard Deviation 2.86 |
| GRASPA 100 IU/kg | Summary of Free Asparaginase Over Time | Induction 1, D3 | 3.38 U/L | Standard Deviation 0.16 |
| GRASPA 100 IU/kg | Summary of Free Asparaginase Over Time | Induction 1, D4 | 6.87 U/L | Standard Deviation 5.77 |
| GRASPA 100 IU/kg | Summary of Free Asparaginase Over Time | Induction 1, D10 | 0.53 U/L | Standard Deviation 0.23 |
| GRASPA 100 IU/kg | Summary of Free Asparaginase Over Time | Induction 1, D17 | 0.34 U/L | Standard Deviation 0.1 |
| GRASPA 100 IU/kg | Summary of Free Asparaginase Over Time | Induction 1, D22-28 | 0.59 U/L | Standard Deviation 0.37 |
| GRASPA 100 IU/kg | Summary of Free Asparaginase Over Time | Induction 2, D6 | 1.19 U/L | Standard Deviation 1.03 |
| GRASPA 100 IU/kg | Summary of Free Asparaginase Over Time | Induction 2, D13 | 0.52 U/L | Standard Deviation 0.35 |
| GRASPA 100 IU/kg | Summary of Free Asparaginase Over Time | Induction 2, D20 | 0.46 U/L | Standard Deviation 0.42 |
| GRASPA 100 IU/kg | Summary of Free Asparaginase Over Time | Induction 2, D22-28 | 0.68 U/L | Standard Deviation 0.95 |
| GRASPA 150 IU/kg | Summary of Free Asparaginase Over Time | Induction 2, D7 | 4.96 U/L | Standard Deviation 3.78 |
| GRASPA 150 IU/kg | Summary of Free Asparaginase Over Time | Induction 1, D10 | 0.51 U/L | Standard Deviation 0.3 |
| GRASPA 150 IU/kg | Summary of Free Asparaginase Over Time | Induction 1, D3 | 3.33 U/L | Standard Deviation 0 |
| GRASPA 150 IU/kg | Summary of Free Asparaginase Over Time | Induction 2, D13 | 0.45 U/L | Standard Deviation 0.38 |
| GRASPA 150 IU/kg | Summary of Free Asparaginase Over Time | Induction 1, D4 | 4.96 U/L | Standard Deviation 2.63 |
| GRASPA 150 IU/kg | Summary of Free Asparaginase Over Time | Induction 2, D22-28 | 0.35 U/L | Standard Deviation 0.1 |
| GRASPA 150 IU/kg | Summary of Free Asparaginase Over Time | Induction 1, D22-28 | 0.49 U/L | Standard Deviation 0.32 |
| GRASPA 150 IU/kg | Summary of Free Asparaginase Over Time | Induction 1, D17 | 0.42 U/L | Standard Deviation 0.26 |
| GRASPA 150 IU/kg | Summary of Free Asparaginase Over Time | Induction 2, D20 | 0.24 U/L | Standard Deviation 0.07 |
| GRASPA 150 IU/kg | Summary of Free Asparaginase Over Time | Induction 2, D6 | 0.52 U/L | Standard Deviation 0.18 |