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Trial record 28 of 80 for:    ASNS

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
Results First Posted : June 14, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
ERYtech Pharma

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Lymphoblastic Leukemia
Intervention Drug: GRASPA
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

Period Title: Overall Study
Started 3 13 14
Completed 2 13 9
Not Completed 1 0 5
Arm/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg Total
Hide Arm/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.

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 3 13 14 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 13 participants 14 participants 30 participants
68.33
(65.0 to 72.0)
66.92
(59.0 to 77.0)
67.00
(61.0 to 77.0)
67.10
(59.0 to 77.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 13 participants 14 participants 30 participants
Female
2
  66.7%
6
  46.2%
8
  57.1%
16
  53.3%
Male
1
  33.3%
7
  53.8%
6
  42.9%
14
  46.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 3 participants 13 participants 14 participants 30 participants
3 13 14 30
1.Primary Outcome
Title Efficacy Primary Endpoint - Percentage of Patients Responding to Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

Overall Number of Participants Analyzed 3 13 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
11
  84.6%
10
  71.4%
2.Secondary Outcome
Title Safety Endpoint - DLTs Assessed During Induction 1 and Induction 2
Hide Description

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, 3, 4 of 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.

Information in a previous submission of this record indicated that "Number of Participants with DLTs" was included as a Secondary Outcome Measure, however only the number of DLTs is a pre-specified Secondary Outcome Measure.

Time Frame Induction 1 and Induction 2
Hide Outcome Measure Data
Hide Analysis Population Description
22 total DLTs occurred.
Arm/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

Overall Number of Participants Analyzed 3 13 14
Measure Type: Number
Unit of Measure: DLTs
0 5 17
3.Secondary Outcome
Title Plasma Concentrations of Asparagine
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

Overall Number of Participants Analyzed 3 13 14
Mean (Standard Deviation)
Unit of Measure: μmol/L
Induction 1, Day 3 Number Analyzed 3 participants 13 participants 14 participants
60.86  (9.38) 46.74  (21.44) 42.33  (10.98)
Induction 1, Day 4 Number Analyzed 3 participants 13 participants 14 participants
0.51  (0) 0.51  (0) 0.51  (0)
Induction 1, Day 10 Number Analyzed 3 participants 13 participants 14 participants
17.48  (11.46) 1.78  (3.39) 3.11  (4.05)
Induction 1, Day 17 Number Analyzed 3 participants 13 participants 13 participants
16.33  (9.62) 10.05  (8.10) 9.30  (7.39)
Induction 1, Day 22-28 Number Analyzed 2 participants 11 participants 12 participants
24.55  (1.60) 20.35  (10.60) 18.76  (8.74)
Induction 2, Day 6 Number Analyzed 2 participants 12 participants 9 participants
45.39  (1.24) 28.11  (9.74) 27.16  (14.45)
Induction 2, Day 7 Number Analyzed 2 participants 12 participants 9 participants
9.41  (12.59) 9.44  (16.23) 0.51  (0)
Induction 2, Day 13 Number Analyzed 2 participants 11 participants 9 participants
29.47  (34.69) 10.37  (11.16) 3.79  (6.58)
Induction 2, Day 20 Number Analyzed 2 participants 11 participants 9 participants
34.20  (8.48) 13.71  (10.40) 12.91  (8.17)
Induction 2, Day 22 to D28 Number Analyzed 2 participants 10 participants 8 participants
46.22  (28.92) 17.27  (12.12) 17.23  (4.77)
4.Secondary Outcome
Title Plasma Concentrations of Aspartic Acid
Hide Description Mean plasma concentration of aspartic acid over time.
Time Frame Induction 1 and Induction 2
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

Overall Number of Participants Analyzed 3 13 14
Mean (Standard Deviation)
Unit of Measure: μmol/L
Induction 1, D3 Number Analyzed 3 participants 13 participants 14 participants
1.91  (0.28) 2.38  (4.39) 3.59  (5.03)
Induction 1, D4 Number Analyzed 3 participants 13 participants 14 participants
11.08  (4.14) 5.22  (1.81) 8.11  (5.50)
Induction 1, D10 Number Analyzed 3 participants 13 participants 14 participants
17.93  (3.65) 16.47  (6.17) 13.51  (5.16)
Induction 1, D17 Number Analyzed 3 participants 13 participants 13 participants
3.76  (1.39) 10.60  (6.02) 8.43  (4.58)
Induction 1, D22-28 Number Analyzed 2 participants 12 participants 13 participants
5.17  (1.82) 10.27  (9.88) 6.93  (5.31)
Induction 2, D6 Number Analyzed 2 participants 12 participants 9 participants
2.32  (0.63) 4.17  (4.31) 5.08  (3.35)
Induction 2, D7 Number Analyzed 2 participants 12 participants 9 participants
12.06  (6.36) 6.35  (3.67) 7.59  (3.45)
Induction 2, D13 Number Analyzed 2 participants 11 participants 9 participants
9.07  (8.92) 9.82  (6.52) 10.07  (5.19)
Induction 2, D20 Number Analyzed 2 participants 11 participants 9 participants
2.56  (0.37) 8.39  (6.58) 7.06  (5.28)
Induction 2, D22-28 Number Analyzed 2 participants 10 participants 9 participants
3.37  (1.00) 11.04  (8.66) 6.32  (4.75)
5.Secondary Outcome
Title Plasma Concentrations of Glutamine
Hide Description Mean glutamine concentration over time.
Time Frame Induction 1 and Induction 2
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

Overall Number of Participants Analyzed 3 13 14
Mean (Standard Deviation)
Unit of Measure: μmol/L
Induction 1, D3 Number Analyzed 3 participants 13 participants 14 participants
558.78  (158.02) 484.19  (137.05) 432.07  (69.93)
Induction 1, D4 Number Analyzed 3 participants 13 participants 14 participants
616.13  (184.59) 494.76  (142.95) 463.03  (117.79)
Induction 1, D10 Number Analyzed 3 participants 13 participants 14 participants
576.86  (172.51) 521.86  (180.41) 447.07  (159.93)
Induction 1, D17 Number Analyzed 3 participants 13 participants 13 participants
384.12  (28.05) 344.03  (102.95) 266.08  (71.48)
Induction 1, D22-28 Number Analyzed 2 participants 12 participants 13 participants
394.53  (21.50) 422.76  (175.67) 393.87  (78.01)
Induction 2, D6 Number Analyzed 2 participants 12 participants 9 participants
508.99  (17.53) 436.71  (140.02) 426.28  (72.15)
Induction 2, D7 Number Analyzed 2 participants 12 participants 9 participants
553.63  (71.15) 498.41  (131.33) 445.00  (145.95)
Induction 2, D13 Number Analyzed 2 participants 11 participants 9 participants
517.42  (50.94) 467.52  (136.17) 456.52  (113.75)
Induction 2, D20 Number Analyzed 2 participants 11 participants 9 participants
436.17  (15.72) 406.62  (101.32) 394.51  (69.15)
Induction 2, D22-28 Number Analyzed 2 participants 10 participants 9 participants
530.40  (167.13) 504.97  (117.83) 441.50  (60.63)
6.Secondary Outcome
Title Plasma Concentrations of Glutamic Acid.
Hide Description Mean glutamic acid concentration over time.
Time Frame Induction 1 and Induction 2
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

Overall Number of Participants Analyzed 3 13 14
Mean (Standard Deviation)
Unit of Measure: μmol/L
Induction 1, D3 Number Analyzed 3 participants 13 participants 14 participants
49.96  (17.23) 28.68  (18.01) 39.87  (49.71)
Induction 1, D4 Number Analyzed 3 participants 13 participants 14 participants
94.73  (35.53) 54.38  (29.68) 52.17  (29.01)
Induction 1, D10 Number Analyzed 3 participants 13 participants 14 participants
53.58  (6.94) 31.87  (17.41) 31.82  (23.20)
Induction 1, D17 Number Analyzed 3 participants 13 participants 13 participants
65.73  (21.31) 39.71  (27.67) 31.57  (23.33)
Induction 1, D22-28 Number Analyzed 2 participants 12 participants 13 participants
42.83  (2.56) 46.74  (27.49) 36.49  (22.90)
Induction 2, D6 Number Analyzed 2 participants 12 participants 9 participants
58.94  (37.41) 53.88  (29.03) 55.94  (32.51)
Induction 2, D7 Number Analyzed 2 participants 12 participants 9 participants
77.11  (29.37) 63.51  (35.37) 83.98  (49.74)
Induction 2, D13 Number Analyzed 2 participants 11 participants 9 participants
34.70  (9.57) 53.64  (27.70) 52.24  (23.91)
Induction 2, D20 Number Analyzed 2 participants 11 participants 9 participants
27.83  (7.63) 42.86  (20.70) 35.09  (14.87)
Induction 2, D22-28 Number Analyzed 2 participants 10 participants 9 participants
56.21  (1.85) 47.92  (31.07) 42.62  (11.94)
7.Secondary Outcome
Title Cerebral Spinal Fluid Concentrations of Asparagine
Hide Description Mean cerebral spinal fluid asparagine concentration over time.
Time Frame Induction 1 and Induction 2
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

Overall Number of Participants Analyzed 2 12 9
Mean (Standard Deviation)
Unit of Measure: μmol/L
Induction 1, D2 Number Analyzed 2 participants 12 participants 8 participants
5.98  (0.63) 8.35  (3.20) 6.06  (3.17)
Induction 1, D9 Number Analyzed 2 participants 12 participants 9 participants
6.57  (2.72) 1.47  (1.28) 1.61  (1.09)
Induction 2, D2 Number Analyzed 2 participants 12 participants 6 participants
6.24  (1.07) 6.42  (2.62) 7.59  (5.58)
Induction 2, D9 Number Analyzed 2 participants 11 participants 5 participants
5.09  (2.99) 2.74  (4.24) 0.52  (0.03)
8.Secondary Outcome
Title Cerebral Spinal Fluid Concentrations of Aspartic Acid
Hide Description Mean cerebral spinal fluid aspartic acid concentration
Time Frame Induction 1 and Induction 2
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

Overall Number of Participants Analyzed 2 12 9
Mean (Standard Deviation)
Unit of Measure: μmol/L
Induction 1, D2 Number Analyzed 2 participants 12 participants 9 participants
.95  (0.00) .95  (0.00) .95  (0.01)
Induction 1, D9 Number Analyzed 2 participants 12 participants 9 participants
.95  (0.00) 1.04  (0.32) 1.10  (0.46)
Induction 2, D2 Number Analyzed 2 participants 12 participants 6 participants
.95  (0.00) .95  (0.00) 1.35  (0.98)
Induction 2, D9 Number Analyzed 2 participants 11 participants 5 participants
.95  (0.00) 1.09  (0.26) .95  (0.00)
9.Secondary Outcome
Title Cerebral Spinal Fluid Concentrations of Glutamine
Hide Description Mean cerebral spinal fluid glutamine concentration
Time Frame Induction 1 and Induction 2
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

Overall Number of Participants Analyzed 2 12 9
Mean (Standard Deviation)
Unit of Measure: μmol/L
Induction 1, D2 Number Analyzed 2 participants 12 participants 9 participants
270.57  (108.21) 441.34  (239.50) 408.56  (116.84)
Induction 1, D9 Number Analyzed 2 participants 12 participants 9 participants
395.76  (32.50) 363.40  (142.12) 360.57  (99.56)
Induction 2, D2 Number Analyzed 2 participants 12 participants 6 participants
345.41  (4.13) 358.90  (107.03) 378.14  (70.19)
Induction 2, D9 Number Analyzed 2 participants 11 participants 5 participants
372.56  (15.67) 420.96  (93.42) 351.30  (44.86)
10.Secondary Outcome
Title Cerebral Spinal Fluid Concentrations of Glutamic Acid
Hide Description Mean cerebral spinal fluid glutamic acid concentration
Time Frame Induction 1 and Induction 2
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

Overall Number of Participants Analyzed 2 12 9
Mean (Standard Deviation)
Unit of Measure: μmol/L
Induction 1, D2 Number Analyzed 2 participants 12 participants 9 participants
91.55  (39.44) 91.98  (85.00) 61.48  (53.96)
Induction 1, D9 Number Analyzed 2 participants 12 participants 9 participants
132.53  (15.09) 71.78  (38.44) 43.93  (30.53)
Induction 2, D2 Number Analyzed 2 participants 12 participants 6 participants
69.35  (5.70) 52.89  (24.63) 41.24  (20.18)
Induction 2, D9 Number Analyzed 2 participants 11 participants 5 participants
62.04  (8.37) 60.30  (28.32) 47.02  (39.12)
11.Secondary Outcome
Title Summary of Free Asparaginase Over Time
Hide Description [Not Specified]
Time Frame Induction 1 and Induction 2
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

Overall Number of Participants Analyzed 3 13 14
Mean (Standard Deviation)
Unit of Measure: U/L
Induction 1, D3 Number Analyzed 3 participants 13 participants 14 participants
3.33  (0.00) 3.38  (0.16) 3.33  (0.00)
Induction 1, D4 Number Analyzed 3 participants 13 participants 14 participants
2.21  (0.57) 6.87  (5.77) 4.96  (2.63)
Induction 1, D10 Number Analyzed 3 participants 13 participants 14 participants
0.48  (0.09) 0.53  (0.23) 0.51  (0.30)
Induction 1, D17 Number Analyzed 3 participants 13 participants 13 participants
0.73  (0.38) 0.34  (0.10) 0.42  (0.26)
Induction 1, D22-28 Number Analyzed 2 participants 13 participants 12 participants
0.66  (0.11) 0.59  (0.37) 0.49  (0.32)
Induction 2, D6 Number Analyzed 2 participants 12 participants 9 participants
3.33  (0.00) 1.19  (1.03) 0.52  (0.18)
Induction 2, D7 Number Analyzed 2 participants 12 participants 9 participants
1.47  (1.65) 3.50  (2.86) 4.96  (3.78)
Induction 2, D13 Number Analyzed 2 participants 11 participants 9 participants
0.35  (0.02) 0.52  (0.35) 0.45  (0.38)
Induction 2, D20 Number Analyzed 2 participants 11 participants 9 participants
0.45  (0.04) 0.46  (0.42) 0.24  (0.07)
Induction 2, D22-28 Number Analyzed 1 participants 10 participants 8 participants
0.49  (0.00) 0.68  (0.95) 0.35  (0.10)
12.Secondary Outcome
Title Summary of Encapsulated Asparaginase (U/L) Over Time
Hide Description [Not Specified]
Time Frame Induction 1 and Induction 2
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

Overall Number of Participants Analyzed 3 13 14
Mean (Standard Deviation)
Unit of Measure: U/L
Induction 1, D3 Number Analyzed 3 participants 13 participants 14 participants
72.50  (0.00) 239.49  (602.11) 72.50  (0.00)
Induction 1, D4 Number Analyzed 3 participants 13 participants 14 participants
915.32  (137.09) 1308.48  (490.99) 1795.03  (564.74)
Induction 1, D10 Number Analyzed 3 participants 13 participants 14 participants
579.22  (129.99) 1105.24  (339.77) 1309.08  (497.53)
Induction 1, D17 Number Analyzed 3 participants 13 participants 13 participants
402.41  (181.91) 790.39  (193.78) 793.97  (291.67)
Induction 1, D22-28 Number Analyzed 2 participants 13 participants 12 participants
383.59  (62.77) 571.49  (225.69) 629.35  (253.60)
Induction 2, D6 Number Analyzed 2 participants 12 participants 9 participants
72.50  (0.00) 382.51  (275.00) 524.37  (164.72)
Induction 2, D7 Number Analyzed 2 participants 12 participants 9 participants
722.57  (120.11) 1223.20  (323.83) 1913.32  (788.45)
Induction 2, D13 Number Analyzed 2 participants 11 participants 9 participants
714.90  (49.91) 1051.64  (285.32) 1536.06  (401.09)
Induction 2, D20 Number Analyzed 2 participants 11 participants 9 participants
556.00  (52.10) 745.22  (288.06) 1191.24  (450.38)
Induction 2, D22-28 Number Analyzed 1 participants 10 participants 8 participants
509.20  (0) 673.64  (307.10) 813.98  (240.88)
13.Secondary Outcome
Title Number of Patients Positive for Anti-L-asparaginase Antibodies
Hide Description Evaluation of the number of patients testing positive for anti-asparaginase antibodies.
Time Frame Induction 1 and Induction 2
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

Overall Number of Participants Analyzed 3 13 14
Measure Type: Count of Participants
Unit of Measure: Participants
Induction 1, D3 Number Analyzed 3 participants 13 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
Induction 1, D4 Number Analyzed 3 participants 13 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
Induction 1, D22-28 Number Analyzed 2 participants 13 participants 12 participants
0
   0.0%
1
   7.7%
1
   8.3%
Induction 2, D6 Number Analyzed 0 participants 1 participants 6 participants
0
0
   0.0%
1
  16.7%
Induction 2, D22-28 Number Analyzed 2 participants 11 participants 9 participants
1
  50.0%
4
  36.4%
5
  55.6%
14.Secondary Outcome
Title Number of Participants With Complete Remission (CR) Rate Following Induction 1 and Induction 2
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

Overall Number of Participants Analyzed 2 13 13
Measure Type: Count of Participants
Unit of Measure: Participants
Participants who met CR criteria at Induction 1 Number Analyzed 2 participants 13 participants 13 participants
2
 100.0%
10
  76.9%
8
  61.5%
Participants who met CR criteria at Induction 2 Number Analyzed 2 participants 11 participants 9 participants
2
 100.0%
10
  90.9%
7
  77.8%
Time Frame The period of adverse event (AE) reporting was from the patient inclusion until the end of the product safety follow-up, reached 2 months after the last GRASPA® administration, thus theoretically corresponding to the end of the 2nd cycle of consolidation (Visit V12).
Adverse Event Reporting Description Some Adverse Events were monitored/assessed without regard to the specific Adverse Event Term (i.e. "Gastrointestinal Disorder" and "General Disorder").
 
Arm/Group Title GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Hide Arm/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.

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

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

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

All-Cause Mortality
GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/3 (33.33%)   2/13 (15.38%)   3/14 (21.43%) 
Show Serious Adverse Events Hide Serious Adverse Events
GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   13/13 (100.00%)   13/14 (92.86%) 
Blood and lymphatic system disorders       
Febrile bone marrow aplasia  1  1/3 (33.33%)  3/13 (23.08%)  1/14 (7.14%) 
Bone marrow failure  1  0/3 (0.00%)  2/13 (15.38%)  0/14 (0.00%) 
Pancytopenia  1  0/3 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Thrombocytopenia  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Cardiac disorders       
Arrythmia  1  1/3 (33.33%)  0/13 (0.00%)  0/14 (0.00%) 
Gastrointestinal disorders       
Gastrointestinal haemorrhage  1  0/3 (0.00%)  1/13 (7.69%)  1/14 (7.14%) 
Faecaloma  1  1/3 (33.33%)  0/13 (0.00%)  0/14 (0.00%) 
Haemmorhoids  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Rectal haemorrhage  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
General disorders       
Generalised oedema  1  0/3 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Infusion site ulcer  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Multi-organ failure  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Hepatobiliary disorders       
Cytolytic hepatitis  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Immune system disorders       
Drug hypersensitivity  1  0/3 (0.00%)  2/13 (15.38%)  4/14 (28.57%) 
Infections and infestations       
Septic Shock  1  0/3 (0.00%)  3/13 (23.08%)  3/14 (21.43%) 
Escherichia sepsis  1  1/3 (33.33%)  2/13 (15.38%)  0/14 (0.00%) 
Aspergillosis  1  0/3 (0.00%)  1/13 (7.69%)  1/14 (7.14%) 
Bronchopulmonary aspergillosis  1  0/3 (0.00%)  1/13 (7.69%)  1/14 (7.14%) 
Pneumonia herpes viral  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Sepsis  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Bacterial Sepsis  1  1/3 (33.33%)  0/13 (0.00%)  0/14 (0.00%) 
Cellulitis  1  0/3 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Citrobacter infection  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Diverticulitis  1  1/3 (33.33%)  0/13 (0.00%)  0/14 (0.00%) 
Escherichia bacteraemia  1  0/3 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Herpes zoster  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Klebsiella sepsis  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Lung infection  1  0/3 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Pneumocystitis jroveci infection  1  1/3 (33.33%)  0/13 (0.00%)  0/14 (0.00%) 
Pseudomonal sepsis  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Staphylococcal sepsis  1  0/3 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Stenotrophomonas sepsis  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Investigations       
Antithrombin III decreased  1  0/3 (0.00%)  0/13 (0.00%)  2/14 (14.29%) 
Pancreatic enzymes increased  1  0/3 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Metabolism and nutrition disorders       
Hypoalbuminemia  1  0/3 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Tumor lysis syndrome  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Hypernatremia  1  0/3 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Leukemia recurrent  1  1/3 (33.33%)  6/13 (46.15%)  5/14 (35.71%) 
Myelodysplastic syndrome  1  0/3 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Nervous system disorders       
Metabolic encephalopathy  1  0/3 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Renal and urinary disorders       
Renal failure  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Lung disorder  1  0/3 (0.00%)  3/13 (23.08%)  0/14 (0.00%) 
Haemoptysis  1  0/3 (0.00%)  2/13 (15.38%)  0/14 (0.00%) 
Pulmonary oedema  1  0/3 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Vascular disorders       
Cerebrovascualr accident  1  0/3 (0.00%)  0/13 (0.00%)  2/14 (14.29%) 
Subarachnoid haemorrhage  1  0/3 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
Subclavian vein thrombosis  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Venous thrombosis  1  0/3 (0.00%)  0/13 (0.00%)  1/14 (7.14%) 
1
Term from vocabulary, MedDRA 14.0 (2011)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GRASPA 50 IU/kg GRASPA 100 IU/kg GRASPA 150 IU/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   13/13 (100.00%)   14/14 (100.00%) 
Blood and lymphatic system disorders       
Febrile bone marrow aplasia  1  1/3 (33.33%)  3/13 (23.08%)  4/14 (28.57%) 
Febrile neutropenia  1  0/3 (0.00%)  1/13 (7.69%)  2/14 (14.29%) 
Gastrointestinal disorders       
Gastrointestinal disorders  1  1/3 (33.33%)  3/13 (23.08%)  2/14 (14.29%) 
General disorders       
General disorder  1  0/3 (0.00%)  3/13 (23.08%)  2/14 (14.29%) 
Hepatobiliary disorders       
Cytolytic hepatitis  1  1/3 (33.33%)  3/13 (23.08%)  4/14 (28.57%) 
Hyperbilirubinaemia  1  0/3 (0.00%)  2/13 (15.38%)  1/14 (7.14%) 
Immune system disorders       
Drug hypersensitivity  1  1/3 (33.33%)  2/13 (15.38%)  4/14 (28.57%) 
Infections and infestations       
Septic Shock  1  0/3 (0.00%)  3/13 (23.08%)  3/14 (21.43%) 
Aspergillosis  1  1/3 (33.33%)  2/13 (15.38%)  1/14 (7.14%) 
Bronchopulmonary aspergillosis  1  0/3 (0.00%)  1/13 (7.69%)  2/14 (14.29%) 
Escherichia sepsis  1  1/3 (33.33%)  2/13 (15.38%)  0/14 (0.00%) 
Lung infection  1  0/3 (0.00%)  1/13 (7.69%)  2/14 (14.29%) 
Oral herpes  1  0/3 (0.00%)  2/13 (15.38%)  1/14 (7.14%) 
Investigations       
Antithrombin III decreased  1  2/3 (66.67%)  7/13 (53.85%)  12/14 (85.71%) 
Gamma-glutamyltransferase increased  1  1/3 (33.33%)  6/13 (46.15%)  4/14 (28.57%) 
Alanine aminotransferase increased  1  1/3 (33.33%)  4/13 (30.77%)  4/14 (28.57%) 
Blood glucose increased  1  1/3 (33.33%)  4/13 (30.77%)  4/14 (28.57%) 
Blood bilirubin increased  1  0/3 (0.00%)  6/13 (46.15%)  2/14 (14.29%) 
Blood fibrinogen decreased  1  0/3 (0.00%)  3/13 (23.08%)  4/14 (28.57%) 
Lipase increased  1  1/3 (33.33%)  2/13 (15.38%)  3/14 (21.43%) 
Prothrombin level decreased  1  0/3 (0.00%)  1/13 (7.69%)  5/14 (35.71%) 
Activated partial thromboplastin time prolonged  1  2/3 (66.67%)  0/13 (0.00%)  3/14 (21.43%) 
Blood albumin decreased  1  1/3 (33.33%)  2/13 (15.38%)  1/14 (7.14%) 
Pancreatic enzymes increased  1  0/3 (0.00%)  2/13 (15.38%)  2/14 (14.29%) 
Aspartate aminotransferase increased  1  1/3 (33.33%)  1/13 (7.69%)  1/14 (7.14%) 
Metabolism and nutrition disorders       
Hypoalbuminaemia  1  1/3 (33.33%)  1/13 (7.69%)  8/14 (57.14%) 
Hyponatraemia  1  1/3 (33.33%)  2/13 (15.38%)  4/14 (28.57%) 
Hypocalcaemia  1  1/3 (33.33%)  2/13 (15.38%)  3/14 (21.43%) 
Hypokalaemia  1  0/3 (0.00%)  4/13 (30.77%)  2/14 (14.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Leukemia recurrent  1  1/3 (33.33%)  6/13 (46.15%)  5/14 (35.71%) 
Nervous system disorders       
Nervous system  1  1/3 (33.33%)  2/13 (15.38%)  2/14 (14.29%) 
Renal and urinary disorders       
Renal failure acute  1  0/3 (0.00%)  1/13 (7.69%)  1/14 (7.14%) 
Renal failure  1  0/3 (0.00%)  1/13 (7.69%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory disorders  1  0/3 (0.00%)  4/13 (30.77%)  1/14 (7.14%) 
Vascular disorders       
Vascular disorder  1  1/3 (33.33%)  2/13 (15.38%)  5/14 (35.71%) 
1
Term from vocabulary, MedDRA 14.0 (2011)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Denise Tilton, Global Head Clinical Operations & Program Management
Organization: ERYTECH Pharma
Phone: +1 857-706-1587
EMail: dtilton@erytech.com
Layout table for additonal information
Responsible Party: ERYtech Pharma
ClinicalTrials.gov Identifier: NCT01523782     History of Changes
Other Study ID Numbers: GRASPALL/GRAALLSA2-2008
First Submitted: January 16, 2012
First Posted: February 1, 2012
Results First Submitted: July 11, 2017
Results First Posted: June 14, 2018
Last Update Posted: July 11, 2018