Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
Study Details
Study Description
Brief Summary
This randomized clinical trial is studying giving calaspargase pegol together with combination chemotherapy to see how well it works compared with giving pegaspargase together with combination chemotherapy in treating younger patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
PRIMARY OBJECTIVES:
- To determine the pharmacokinetic comparability of EZN-2285 (calaspargase pegol) compared to Oncaspar (pegaspargase) given intravenously during induction and consolidation in patients with high-risk ALL receiving augmented Berlin-Frankfurt-Munster (BFM) therapy.
SECONDARY OBJECTIVES:
-
To describe the pharmacodynamics (PD) of EZN-2285 compared to Oncaspar given intravenously during induction and consolidation in patients with high-risk ALL receiving augmented BFM therapy.
-
To determine end of induction therapy day 29 minimal residual disease (MRD) for patients randomized to the EZN-2285 containing regimen compared to the Oncaspar® containing regimen.
-
To determine the complete remission (CR) rates for patients receiving EZN-2285 by day 29 of induction compared to Oncaspar.
-
To assess event-free survival (EFS) associated with the administration of EZN-2285 given during augmented post Induction intensification therapy to patients with high-risk ALL compared to Oncaspar.
-
To determine the proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on days 4, 15, 22 and 29 of induction compared to Oncaspar.
-
To determine the plasma and cerebrospinal fluid (CSF) concentrations of asparagine after administration of EZN-2285 compared to Oncaspar.
-
To assess the immunogenicity of EZN-2285 including the detection of binding and neutralizing antibodies compared to Oncaspar.
-
To assess the tolerability and toxicities associated with the administration of EZN-2285 given during augmented post induction intensification therapy to patients with high risk ALL compared to Oncaspar.
-
To explore the relationship between the terminal pharmacokinetics (PK) of EZN-2285 and the presence of antibodies.
OUTLINE: This is a multicenter study. Patients are stratified according to response to induction therapy (slow early responders [SER] vs rapid early responders [RER]. Patients are randomized to 1 of 2 treatment arms in 2:1 ratio (arm I: arm II) (patients randomized to arm I receive study drug calaspargase pegol*; patients randomized to arm II receive study drug pegaspargase).
INDUCTION THERAPY** (ALL PATIENTS): Patients receive cytarabine intrathecally (IT) on day 1; vincristine intravenously (IV) and daunorubicin hydrochloride IV over 15 minutes on days 1, 8, 15, and 22; prednisone orally or IV twice daily (BID) on days 1-28; study drug IV over 1 hour on day 4; and methotrexate IT on days 8, 15*, 22*, and 29. Patients are assessed for response on day 8 and/or day 15 and day 29. Patients who achieve M1 marrow on day 8 or 15 and negative MRD (i.e., < 0.1%) on day 29 are considered RER. Patients who achieve M2 or M3 marrow on day 15 OR MRD >= 0.1% but < 1% on day 29 are considered SER. Patients with M3 bone marrow are removed from the study. RER and SER proceed to consolidation therapy. Patients with M2 marrow or M1 marrow with >= 1% MRD receive extended induction therapy. Patients also receive dexamethasone PO or IV BID on days 1-14 (patients < 10 years) or prednisone BID on days 1-28 (patients >= 10 years)
NOTE: *For patients with CNS3 disease only.
EXTENDED INDUCTION THERAPY**: Patients receive vincristine IV on days 1 and 8; prednisone orally (PO) or IV BID on days 1-14; daunorubicin hydrochloride IV over 15 minutes on day 1; and study drug IV over 1 hour on day 4. Patients are assessed for response on day 43. Patients who achieve M1 and MRD < 1% are treated as SER (proceed to consolidation therapy). All other patients are removed from study.
CONSOLIDATION THERAPY** (ALL PATIENTS): Beginning on day 36 (after completion of induction therapy) or after completion of extended induction therapy, patients (RER and SER) receive cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV or SC on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO on days 1-14 and 29-42; vincristine IV on days 15, 22, 43, and 50; study drug IV over 1 hour on days 15 and 43; and methotrexate IT on days 1, 8, 15*, and 22*. Patients then proceed to interim maintenance I therapy.
NOTE: *Omit doses for patients with CNS3 disease.
INTERIM MAINTENANCE I** (ALL PATIENTS): Patients receive vincristine IV and methotrexate** IV on days 1, 11, 21, 31, and 41; study drug IV over 1 hour on days 2 and 22; and methotrexate IT on days 1 and 31. Patients then proceed to delayed intensification I therapy.
DELAYED INTENSIFICATION I** (ALL PATIENTS): Patients receive vincristine IV on days 1, 8, 15, 43, and 50; dexamethasone PO or IV BID on days 1-21 for patients age 1-9, or on days 1-7 and 15-21 for patients age >= 10; doxorubicin hydrochloride IV over 15 minutes on days 1, 8, and 15; study drug IV over 1 hour on days 4 and 43; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV or subcutaneously (SC) on days 29-32 and 36-39; thioguanine PO on days 29-42; and methotrexate IT on days 1, 29, and 36. Patients treated as RER proceed to maintenance therapy. Patients treated as SER (i.e., patients with CNS3 disease at diagnosis, or pre-treated with steroids, or who are RERs with mixed lineage leukemia [MLL] gene rearrangements) proceed to interim maintenance II followed by delayed intensification II.
INTERIM MAINTENANCE II** (SER ONLY): Patients receive vincristine IV, methotrexate IV, study drug IV, and methotrexate IT as in interim maintenance I.
DELAYED INTENSIFICATION II** (SER ONLY): Beginning on day 29, patients (except patients with CNS3 disease) receive 8 daily fractions of cranial radiotherapy. All patients then receive vincristine IV, dexamethasone PO or IV, doxorubicin hydrochloride IV, study drug IV, cyclophosphamide IV, cytarabine IV or SC, thioguanine PO, and methotrexate IT as in delayed intensification I. Patients who were initially diagnosed with CNS3 disease receive cranial radiotherapy on days 1-5 and 8-12. Patients then proceed to maintenance therapy.
MAINTENANCE THERAPY** (ALL PATIENTS): Patients receive vincristine IV on days 1, 29, and 57; oral dexamethasone on days 1-5, 29-33, and 57-61; mercaptopurine PO on days 1-84; methotrexate IT on day 29; and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for up to 2 years (for female patients) or up to 3 years (for male patients) from the start of interim maintenance I.
NOTE: ** As per amendment #4, most patients receive high-dose methotrexate instead of Capizzi methotrexate at most stages of therapy. CNS3 patients and SER patients who have received cranial irradiation receive planned therapy with no modifications.
NOTE: As per amendment #4, the maximum number of intrathecal treatments is limited by RER/SER/CNS3 status and gender.
Blood and cerebrospinal fluid samples are collected periodically for correlative studies, including immunogenicity, pharmacokinetic, and pharmacodynamic studies.
After completion of study therapy, patients are followed every 2 months for 2 years, every 3 months for 1 year, and then every 6-12 months for 2 years.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm I (combination chemotherapy) Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 4 years. |
Drug: Calaspargase Pegol-mknl
Given IV
Other Names:
Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine
Given IV, IT, PO, or SC
Other Names:
Drug: Daunorubicin Hydrochloride
Given IV
Other Names:
Drug: Dexamethasone
Given PO or IV
Other Names:
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Mercaptopurine
Given PO
Other Names:
Drug: Methotrexate
Given IV, IT, or PO
Other Names:
Drug: Pegaspargase
Given IV
Other Names:
Other: Pharmacological Study
Correlative studies
Drug: Prednisone
Given IV or PO
Other Names:
Radiation: Radiation Therapy
Some patients undergo RT
Other Names:
Drug: Thioguanine
Given PO
Other Names:
Drug: Vincristine Sulfate
Given IV
Other Names:
|
Active Comparator: Arm II (combination chemotherapy) Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 4 years. |
Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Cytarabine
Given IV, IT, PO, or SC
Other Names:
Drug: Daunorubicin Hydrochloride
Given IV
Other Names:
Drug: Dexamethasone
Given PO or IV
Other Names:
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Mercaptopurine
Given PO
Other Names:
Drug: Methotrexate
Given IV, IT, or PO
Other Names:
Drug: Pegaspargase
Given IV
Other Names:
Other: Pharmacological Study
Correlative studies
Drug: Prednisone
Given IV or PO
Other Names:
Radiation: Radiation Therapy
Some patients undergo RT
Other Names:
Drug: Thioguanine
Given PO
Other Names:
Drug: Vincristine Sulfate
Given IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy) [Post Day 29 of Induction and Post Day 22 of Consolidation]
Mean half-life of plasma asparaginase during consolidation and Induction; half-life is defined as the time taken for drug concentration to decrease by half.
Secondary Outcome Measures
- Pharmacodynamics (PD) [Day 29 of consolidation and induction]
Plasma Asparaginase Concentration During consolidation and induction.
- Percentage of Participants With Minimal Residual Disease (MRD)<0.01% at the End of Induction [End of induction (Day 29)]
Percentage of participants with Negative MRD (MRD<0.01%).
- Percentage of Participants With Complete Remission at the End of Induction [End of induction (Day 29)]
Complete Remission (CR) rate; where CR is defined as M1 marrow (< 5% lymphoblasts in the bone marrow)
- Percentage of Participants With Event-free Survival (EFS) [5 Years]
Percentage of participants who were event free. Event Free Probability defined as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignant neoplasm, remission death) or date of last contact for subjects who are event-free.
- Asparaginase Level [Days 4, 15, 22 and 29 of Induction]
The proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on Days 4, 15, 22 and 29 of Induction compared to Oncaspar
- Plasma and CSF Concentrations of Asparagine in ug/ml [25 Days Post-dose (Day 29)]
The plasma and CSF concentrations of asparagine in ug/ml after administration of EZN-2285 compared to Oncaspar.
- Immunogenicity [25 Days Post-dose (Day 29)]
Number of Patients with Positive Immunogenicity tests
- Toxicities During Post Induction Intensification Therapy (All Grades) [Up to 5 years]
The calculation of AE incidence will be based on the number of patients per AE category. For each patient who has multiple AEs classified to the same category, that patient will be tabulated under the worst toxicity grade for that AE category. The incidence of AEs will be tabulated by treatment arm and by organ class. Special attention will be paid to hypersensitivity, pancreatitis, coagulopathy, infection, neurologic dysfunction and thromboembolic events.
- Relationship Between PK and Presence of Antibodies [Day 29 of consolidation]
Patients with presence of Antibodies.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients must be eligible for and enrolled on AALL08B1 or the successor classification study
-
Patients must have newly diagnosed high-risk B lymphoblastic leukemia (World Health Organization [WHO] 2008 classification) (also termed B-precursor acute lymphoblastic leukemia)
-
White blood cell (WBC) >= 50,000/μL for patients age 1-9 OR any WBC count for patients age 10-30 or for patients treated with prior steroids
-
Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) systemic chemotherapy must begin within 72 hours of this intrathecal therapy
-
Patients receiving prior steroid therapy are eligible for this study; the dose and duration of previous steroid therapy should be carefully documented
-
Pregnancy tests with a negative result must be obtained in all post-menarchal females
-
Lactating females must agree that they will not breastfeed a child while on this study
Exclusion Criteria:
-
Patients with Down syndrome are excluded from this study
-
Patients with testicular leukemia at diagnosis are excluded from this study
-
Pregnant female patients are excluded from this study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | United States | 35233 |
2 | Children's Hospital of Orange County | Orange | California | United States | 92868 |
3 | Lucile Packard Children's Hospital Stanford University | Palo Alto | California | United States | 94304 |
4 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
5 | University of Connecticut | Farmington | Connecticut | United States | 06030 |
6 | Connecticut Children's Medical Center | Hartford | Connecticut | United States | 06106 |
7 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
8 | Lurie Children's Hospital-Chicago | Chicago | Illinois | United States | 60611 |
9 | Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
10 | Riley Hospital for Children | Indianapolis | Indiana | United States | 46202 |
11 | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | United States | 21287 |
12 | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
13 | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | United States | 55404 |
14 | University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | United States | 55455 |
15 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
16 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
17 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
18 | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | United States | 10016 |
19 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
20 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
21 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
22 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
23 | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | United States | 15224 |
24 | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
25 | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | United States | 75390 |
26 | Primary Children's Hospital | Salt Lake City | Utah | United States | 84113 |
27 | Seattle Children's Hospital | Seattle | Washington | United States | 98105 |
Sponsors and Collaborators
- Children's Oncology Group
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Anne L Angiolillo, Children's Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AALL07P4
- NCI-2009-00317
- CDR0000594340
- 08-606
- COG-AALL07P4
- AALL07P4
- AALL07P4
- U10CA098543
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Arm I (Calaspargase Pegol 2100) | Arm II (Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) |
---|---|---|---|
Arm/Group Description | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years. |
Period Title: Overall Study | |||
STARTED | 69 | 42 | 55 |
COMPLETED | 30 | 22 | 31 |
NOT COMPLETED | 39 | 20 | 24 |
Baseline Characteristics
Arm/Group Title | Arm I (Calaspargase Pegol 2100) | Arm II (Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) | Total |
---|---|---|---|---|
Arm/Group Description | calaspargase pegol 2100 | calaspargase pegol 2500 | pegaspargase 2500 | Total of all reporting groups |
Overall Participants | 69 | 42 | 55 | 166 |
Age (Count of Participants) | ||||
<=18 years |
62
89.9%
|
40
95.2%
|
51
92.7%
|
153
92.2%
|
Between 18 and 65 years |
7
10.1%
|
2
4.8%
|
4
7.3%
|
13
7.8%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
11.9
(5.58)
|
9.9
(6.09)
|
10.79
(5.54)
|
11.3
(5.72)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
31
44.9%
|
28
66.7%
|
23
41.8%
|
82
49.4%
|
Male |
38
55.1%
|
14
33.3%
|
32
58.2%
|
84
50.6%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||
Hispanic or Latino |
14
20.3%
|
12
28.6%
|
18
32.7%
|
44
26.5%
|
Not Hispanic or Latino |
53
76.8%
|
28
66.7%
|
35
63.6%
|
116
69.9%
|
Unknown or Not Reported |
2
2.9%
|
2
4.8%
|
2
3.6%
|
6
3.6%
|
Race (NIH/OMB) (Count of Participants) | ||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
4
5.8%
|
1
2.4%
|
1
1.8%
|
6
3.6%
|
Native Hawaiian or Other Pacific Islander |
1
1.4%
|
1
2.4%
|
0
0%
|
2
1.2%
|
Black or African American |
4
5.8%
|
1
2.4%
|
6
10.9%
|
11
6.6%
|
White |
56
81.2%
|
35
83.3%
|
43
78.2%
|
134
80.7%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
4
5.8%
|
4
9.5%
|
5
9.1%
|
13
7.8%
|
Outcome Measures
Title | Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy) |
---|---|
Description | Mean half-life of plasma asparaginase during consolidation and Induction; half-life is defined as the time taken for drug concentration to decrease by half. |
Time Frame | Post Day 29 of Induction and Post Day 22 of Consolidation |
Outcome Measure Data
Analysis Population Description |
---|
Analysis restricted to patients who had PK data collected |
Arm/Group Title | Arm I (Calaspargase Pegol 2100) | Arm II ( Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) |
---|---|---|---|
Arm/Group Description | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years. |
Measure Participants | 69 | 42 | 54 |
Asparaginase half-life during Consolidation |
415.8
(148.51)
|
355.9
(133.0)
|
117.2
(49.36)
|
Asparaginase half-life during Induction |
305.1
(98.33)
|
321.5
(118.22)
|
126.9
(50.51)
|
Title | Pharmacodynamics (PD) |
---|---|
Description | Plasma Asparaginase Concentration During consolidation and induction. |
Time Frame | Day 29 of consolidation and induction |
Outcome Measure Data
Analysis Population Description |
---|
Patients who had data collected |
Arm/Group Title | Arm I (Calaspargase Pegol 2100) | Arm II (Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) |
---|---|---|---|
Arm/Group Description | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years. |
Measure Participants | 69 | 42 | 54 |
Plasma Asparaginase Concentration- Consolidation |
575.9
(233.91)
|
617.2
(321.41)
|
562.1
(296.82)
|
Plasma Asparaginase Concentration- Induction |
271.6
(118.17)
|
339.6
(126.83)
|
72.8
(47.94)
|
Title | Percentage of Participants With Minimal Residual Disease (MRD)<0.01% at the End of Induction |
---|---|
Description | Percentage of participants with Negative MRD (MRD<0.01%). |
Time Frame | End of induction (Day 29) |
Outcome Measure Data
Analysis Population Description |
---|
Patients who had data collected. |
Arm/Group Title | Arm I (Calaspargase Pegol 2100) | Arm II (Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) |
---|---|---|---|
Arm/Group Description | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years. |
Measure Participants | 62 | 40 | 47 |
Number (95% Confidence Interval) [Percentage of participants] |
65.2
94.5%
|
81
192.9%
|
72.5
131.8%
|
Title | Percentage of Participants With Complete Remission at the End of Induction |
---|---|
Description | Complete Remission (CR) rate; where CR is defined as M1 marrow (< 5% lymphoblasts in the bone marrow) |
Time Frame | End of induction (Day 29) |
Outcome Measure Data
Analysis Population Description |
---|
Patients who had data collected |
Arm/Group Title | Arm I (Calaspargase Pegol 2100) | Arm II (Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) |
---|---|---|---|
Arm/Group Description | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years. |
Measure Participants | 66 | 42 | 51 |
Number (95% Confidence Interval) [Percentage of participants] |
92.4
133.9%
|
97.6
232.4%
|
94.1
171.1%
|
Title | Percentage of Participants With Event-free Survival (EFS) |
---|---|
Description | Percentage of participants who were event free. Event Free Probability defined as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignant neoplasm, remission death) or date of last contact for subjects who are event-free. |
Time Frame | 5 Years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Arm I (Calaspargase Pegol 2100) | Arm II (Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) |
---|---|---|---|
Arm/Group Description | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years. |
Measure Participants | 69 | 42 | 54 |
Number (95% Confidence Interval) [Percentage of participants] |
72.35
104.9%
|
80.8
192.4%
|
79.34
144.3%
|
Title | Asparaginase Level |
---|---|
Description | The proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on Days 4, 15, 22 and 29 of Induction compared to Oncaspar |
Time Frame | Days 4, 15, 22 and 29 of Induction |
Outcome Measure Data
Analysis Population Description |
---|
Patients who had data collected. |
Arm/Group Title | Arm I (Calaspargase Pegol 2100) | Arm II (Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) |
---|---|---|---|
Arm/Group Description | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years. |
Measure Participants | 69 | 42 | 54 |
Level at least 0.1 IU/mL day 4 |
0
|
0
|
0
|
Level at least 0.1 IU/mL day 15 |
98.4
|
100
|
100
|
Level at least 0.1 IU/mL day 22 |
98.2
|
100
|
95.1
|
Level at least 0.1 IU/mL day 29 |
94.9
|
95.0
|
28.6
|
Level at least 0.4 IU/mL day 4 |
0
|
0
|
0
|
Level at least 0.4 IU/mL day 15 |
75.8
|
95.0
|
93.0
|
Level at least 0.4 IU/mL day 22 |
37.5
|
62.5
|
14.6
|
Level at least 0.4 IU/mL day 29 |
13.6
|
27.5
|
0
|
Title | Plasma and CSF Concentrations of Asparagine in ug/ml |
---|---|
Description | The plasma and CSF concentrations of asparagine in ug/ml after administration of EZN-2285 compared to Oncaspar. |
Time Frame | 25 Days Post-dose (Day 29) |
Outcome Measure Data
Analysis Population Description |
---|
Patients who had data collected. |
Arm/Group Title | Arm I (Calaspargase Pegol 2100) | Arm II (Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) |
---|---|---|---|
Arm/Group Description | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years. |
Measure Participants | 69 | 42 | 54 |
CSF asparagine concentration (ug/mL) |
0.2
(0.108)
|
0.19
(0.086)
|
0.26
(0.26)
|
Plasma asparagine concentration (ug/mL) |
0.2
(0.784)
|
0.25
(1.231)
|
0.83
(2.195)
|
Title | Immunogenicity |
---|---|
Description | Number of Patients with Positive Immunogenicity tests |
Time Frame | 25 Days Post-dose (Day 29) |
Outcome Measure Data
Analysis Population Description |
---|
Patients who had data collected. |
Arm/Group Title | Arm I (Calaspargase Pegol 2100) | Arm II (Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) |
---|---|---|---|
Arm/Group Description | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years. |
Measure Participants | 69 | 42 | 54 |
Count of Participants [Participants] |
2
2.9%
|
2
4.8%
|
4
7.3%
|
Title | Toxicities During Post Induction Intensification Therapy (All Grades) |
---|---|
Description | The calculation of AE incidence will be based on the number of patients per AE category. For each patient who has multiple AEs classified to the same category, that patient will be tabulated under the worst toxicity grade for that AE category. The incidence of AEs will be tabulated by treatment arm and by organ class. Special attention will be paid to hypersensitivity, pancreatitis, coagulopathy, infection, neurologic dysfunction and thromboembolic events. |
Time Frame | Up to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
Patients who had data collected. International normalized ratio (INR). Activated partial thromboplastin (APT) |
Arm/Group Title | Arm I (Calaspargase Pegol 2100) | Arm II (Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) |
---|---|---|---|
Arm/Group Description | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years. |
Measure Participants | 49 | 33 | 43 |
Alergic Reaction - Consolidation |
20.4
29.6%
|
27.3
65%
|
23.3
42.4%
|
Alergic Reaction - Delayed Intensification I |
4.4
6.4%
|
0.0
0%
|
0.0
0%
|
Alergic Reaction - Interim Maintenance I |
0.0
0%
|
0.0
0%
|
2.1
3.8%
|
CNS - Consolidation |
0.0
0%
|
0.0
0%
|
0.0
0%
|
CNS - Delayed Intensification I |
0.0
0%
|
3.8
9%
|
2.6
4.7%
|
CNS - Interim Maintenance I |
0.0
0%
|
0.0
0%
|
0.0
0%
|
Hyperbilirubinemia - Consolidation |
53.1
77%
|
45.5
108.3%
|
30.2
54.9%
|
Hyperbilirubinemia - Delayed Intensification I |
28.9
41.9%
|
38.5
91.7%
|
10.5
19.1%
|
Hyperbilirubinemia - Interim Maintenance I |
41.3
59.9%
|
27.6
65.7%
|
33.3
60.5%
|
Hyperglycemia - Consolidation |
44.9
65.1%
|
42.4
101%
|
46.5
84.5%
|
Hyperglycemia - Delayed Intensification I |
44.4
64.3%
|
61.5
146.4%
|
36.8
66.9%
|
Hyperglycemia - Interim Maintenance I |
34.8
50.4%
|
44.8
106.7%
|
33.3
60.5%
|
Hyperlipidemia - Consolidation |
2.0
2.9%
|
3.0
7.1%
|
7.0
12.7%
|
Hyperlipidemia - Delayed Intensification I |
2.2
3.2%
|
0.0
0%
|
0.0
0%
|
Hyperlipidemia - Interim Maintenance I |
2.2
3.2%
|
3.4
8.1%
|
2.6
4.7%
|
% patients w/INR increase - Consolidation |
6.1
8.8%
|
3.0
7.1%
|
7.0
12.7%
|
% pts w/INR increase - Delayed Intensification I |
6.7
9.7%
|
3.8
9%
|
0.0
0%
|
% patients w/INR increase - Interim Maintenance I |
2.2
3.2%
|
0.0
0%
|
2.6
4.7%
|
Pancreatitis - Consolidation |
10.2
14.8%
|
6.1
14.5%
|
7.0
12.7%
|
Pancreatitis -Delayed Intensification I |
2.2
3.2%
|
7.7
18.3%
|
0.0
0%
|
Pancreatitis - Interim Maintenance I |
2.2
3.2%
|
3.4
8.1%
|
2.6
4.7%
|
% pts w/prolongation of APT time - Consolidation |
8.2
11.9%
|
9.1
21.7%
|
7.0
12.7%
|
% pts w/prolongation APT time -Delayed Intension I |
8.9
12.9%
|
26.9
64%
|
18.4
33.5%
|
%pts w/prolongation APT time-Interim maintenance I |
6.5
9.4%
|
6.9
16.4%
|
7.7
14%
|
Thrombosis - Consolidation |
0.0
0%
|
0.0
0%
|
2.3
4.2%
|
Thrombosis - Delayed Intensification I |
2.2
3.2%
|
0.0
0%
|
0.0
0%
|
Thrombosis - Interim Maintenance I |
0.0
0%
|
0.0
0%
|
0.0
0%
|
Title | Relationship Between PK and Presence of Antibodies |
---|---|
Description | Patients with presence of Antibodies. |
Time Frame | Day 29 of consolidation |
Outcome Measure Data
Analysis Population Description |
---|
These data will never be collected. |
Arm/Group Title | Arm I (Calaspargase Pegol 2100) | Arm II (Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) |
---|---|---|---|
Arm/Group Description | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. | Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years. |
Measure Participants | 0 | 0 | 0 |
Adverse Events
Time Frame | ||||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Arm I (Calaspargase Pegol 2100) | Arm II (Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) | |||
Arm/Group Description | calaspargase pegol 2100 | calaspargase pegol 2500 | pegaspargase 2500 | |||
All Cause Mortality |
||||||
Arm I (Calaspargase Pegol 2100) | Arm II (Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
Arm I (Calaspargase Pegol 2100) | Arm II (Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 54/69 (78.3%) | 34/42 (81%) | 32/54 (59.3%) | |||
Blood and lymphatic system disorders | ||||||
Anemia | 1/69 (1.4%) | 1 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 1 |
Febrile neutropenia | 1/69 (1.4%) | 1 | 4/42 (9.5%) | 4 | 2/54 (3.7%) | 2 |
Hemolysis | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Cardiac disorders | ||||||
Cardiac disorders - Other, specify | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Supraventricular tachycardia | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Gastrointestinal disorders | ||||||
Abdominal pain | 11/69 (15.9%) | 14 | 7/42 (16.7%) | 7 | 4/54 (7.4%) | 4 |
Anal pain | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Ascites | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Constipation | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Duodenal perforation | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Mucositis oral | 1/69 (1.4%) | 1 | 1/42 (2.4%) | 1 | 2/54 (3.7%) | 2 |
Nausea | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Oral pain | 3/69 (4.3%) | 5 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Pancreatic necrosis | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Pancreatitis | 8/69 (11.6%) | 8 | 6/42 (14.3%) | 6 | 4/54 (7.4%) | 4 |
Rectal pain | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Typhlitis | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Vomiting | 0/69 (0%) | 0 | 2/42 (4.8%) | 2 | 2/54 (3.7%) | 2 |
General disorders | ||||||
Death NOS | 4/69 (5.8%) | 4 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 1 |
Fatigue | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Fever | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Irritability | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Pain | 2/69 (2.9%) | 2 | 2/42 (4.8%) | 2 | 1/54 (1.9%) | 2 |
Hepatobiliary disorders | ||||||
Hepatobiliary disorders - Other, specify | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Immune system disorders | ||||||
Anaphylaxis | 13/69 (18.8%) | 13 | 11/42 (26.2%) | 11 | 10/54 (18.5%) | 11 |
Infections and infestations | ||||||
Enterocolitis infectious | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Infections and infestations - Other, specify | 14/69 (20.3%) | 17 | 8/42 (19%) | 10 | 4/54 (7.4%) | 6 |
Infective myositis | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Lung infection | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Sepsis | 2/69 (2.9%) | 2 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Urinary tract infection | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Investigations | ||||||
Activated partial thromboplastin time prolonged | 3/69 (4.3%) | 3 | 3/42 (7.1%) | 3 | 3/54 (5.6%) | 3 |
Alanine aminotransferase increased | 4/69 (5.8%) | 4 | 2/42 (4.8%) | 3 | 5/54 (9.3%) | 6 |
Aspartate aminotransferase increased | 5/69 (7.2%) | 5 | 2/42 (4.8%) | 2 | 4/54 (7.4%) | 4 |
Blood bilirubin increased | 12/69 (17.4%) | 13 | 8/42 (19%) | 10 | 10/54 (18.5%) | 12 |
CPK increased | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Cholesterol high | 2/69 (2.9%) | 4 | 2/42 (4.8%) | 4 | 3/54 (5.6%) | 5 |
Creatinine increased | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Fibrinogen decreased | 4/69 (5.8%) | 4 | 3/42 (7.1%) | 3 | 3/54 (5.6%) | 3 |
GGT increased | 1/69 (1.4%) | 1 | 2/42 (4.8%) | 2 | 1/54 (1.9%) | 1 |
INR increased | 1/69 (1.4%) | 1 | 3/42 (7.1%) | 3 | 0/54 (0%) | 0 |
Investigations - Other, specify | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Lipase increased | 7/69 (10.1%) | 7 | 4/42 (9.5%) | 4 | 4/54 (7.4%) | 4 |
Lymphocyte count decreased | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Neutrophil count decreased | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 2/54 (3.7%) | 2 |
Platelet count decreased | 6/69 (8.7%) | 6 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 2 |
Serum amylase increased | 8/69 (11.6%) | 8 | 1/42 (2.4%) | 1 | 2/54 (3.7%) | 2 |
Weight loss | 3/69 (4.3%) | 3 | 2/42 (4.8%) | 2 | 1/54 (1.9%) | 7 |
White blood cell decreased | 1/69 (1.4%) | 1 | 2/42 (4.8%) | 2 | 1/54 (1.9%) | 1 |
Metabolism and nutrition disorders | ||||||
Acidosis | 0/69 (0%) | 0 | 2/42 (4.8%) | 2 | 0/54 (0%) | 0 |
Anorexia | 5/69 (7.2%) | 7 | 1/42 (2.4%) | 10 | 1/54 (1.9%) | 7 |
Dehydration | 2/69 (2.9%) | 3 | 1/42 (2.4%) | 1 | 3/54 (5.6%) | 4 |
Glucose intolerance | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Hyperglycemia | 21/69 (30.4%) | 27 | 14/42 (33.3%) | 16 | 12/54 (22.2%) | 17 |
Hyperkalemia | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Hypertriglyceridemia | 5/69 (7.2%) | 7 | 4/42 (9.5%) | 7 | 6/54 (11.1%) | 10 |
Hyperuricemia | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Hypoalbuminemia | 5/69 (7.2%) | 6 | 2/42 (4.8%) | 2 | 1/54 (1.9%) | 1 |
Hypocalcemia | 3/69 (4.3%) | 3 | 0/42 (0%) | 0 | 2/54 (3.7%) | 2 |
Hypokalemia | 4/69 (5.8%) | 4 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Hyponatremia | 3/69 (4.3%) | 3 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Hypophosphatemia | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Tumor lysis syndrome | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||
Arthralgia | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Back pain | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Chest wall pain | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Generalized muscle weakness | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Joint effusion | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Muscle weakness left-sided | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Muscle weakness right-sided | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Musculoskeletal and connective tissue disorder - Other, specify | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Myalgia | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Myositis | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Pain in extremity | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Nervous system disorders | ||||||
Arachnoiditis | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Ataxia | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Depressed level of consciousness | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Dizziness | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Dysphasia | 2/69 (2.9%) | 2 | 1/42 (2.4%) | 2 | 0/54 (0%) | 0 |
Encephalopathy | 2/69 (2.9%) | 2 | 3/42 (7.1%) | 3 | 1/54 (1.9%) | 1 |
Headache | 2/69 (2.9%) | 3 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Intracranial hemorrhage | 1/69 (1.4%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Leukoencephalopathy | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Nervous system disorders - Other, specify | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Seizure | 2/69 (2.9%) | 2 | 2/42 (4.8%) | 2 | 1/54 (1.9%) | 1 |
Syncope | 2/69 (2.9%) | 2 | 2/42 (4.8%) | 2 | 3/54 (5.6%) | 3 |
Psychiatric disorders | ||||||
Agitation | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Anxiety | 1/69 (1.4%) | 1 | 2/42 (4.8%) | 2 | 0/54 (0%) | 0 |
Confusion | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Depression | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Psychosis | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Renal and urinary disorders | ||||||
Acute kidney injury | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 2/54 (3.7%) | 2 |
Chronic kidney disease | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||
Adult respiratory distress syndrome | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Cough | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Dyspnea | 3/69 (4.3%) | 3 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 1 |
Epistaxis | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Hypoxia | 6/69 (8.7%) | 6 | 3/42 (7.1%) | 3 | 3/54 (5.6%) | 3 |
Pleural effusion | 3/69 (4.3%) | 3 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders - Other, specify | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||||
Erythema multiforme | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Purpura | 1/69 (1.4%) | 1 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Rash maculo-papular | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Vascular disorders | ||||||
Hematoma | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Hypertension | 3/69 (4.3%) | 3 | 0/42 (0%) | 0 | 3/54 (5.6%) | 3 |
Hypotension | 7/69 (10.1%) | 7 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 1 |
Thromboembolic event | 5/69 (7.2%) | 7 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Vascular disorders - Other, specify | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
Arm I (Calaspargase Pegol 2100) | Arm II (Calaspargase Pegol 2500) | Arm III (Pegaspargase 2500) | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 64/69 (92.8%) | 40/42 (95.2%) | 51/54 (94.4%) | |||
Blood and lymphatic system disorders | ||||||
Anemia | 18/69 (26.1%) | 23 | 16/42 (38.1%) | 27 | 23/54 (42.6%) | 33 |
Blood and lymphatic system disorders - Other, specify | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Disseminated intravascular coagulation | 1/69 (1.4%) | 1 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Febrile neutropenia | 37/69 (53.6%) | 88 | 26/42 (61.9%) | 60 | 31/54 (57.4%) | 56 |
Hemolysis | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Cardiac disorders | ||||||
Left ventricular systolic dysfunction | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Sinus tachycardia | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Ear and labyrinth disorders | ||||||
Middle ear inflammation | 1/69 (1.4%) | 1 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Eye disorders | ||||||
Eye disorders - Other, specify | 1/69 (1.4%) | 2 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Retinal detachment | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Vitreous hemorrhage | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Gastrointestinal disorders | ||||||
Abdominal pain | 7/69 (10.1%) | 7 | 8/42 (19%) | 8 | 6/54 (11.1%) | 9 |
Anal pain | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Ascites | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Colitis | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Diarrhea | 8/69 (11.6%) | 10 | 4/42 (9.5%) | 6 | 2/54 (3.7%) | 2 |
Enterocolitis | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Esophagitis | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Fecal incontinence | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Gastritis | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Ileus | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Lower gastrointestinal hemorrhage | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Malabsorption | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Mucositis oral | 16/69 (23.2%) | 23 | 4/42 (9.5%) | 5 | 7/54 (13%) | 9 |
Nausea | 9/69 (13%) | 10 | 3/42 (7.1%) | 3 | 2/54 (3.7%) | 3 |
Oral hemorrhage | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Oral pain | 6/69 (8.7%) | 7 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 1 |
Pancreatitis | 1/69 (1.4%) | 1 | 2/42 (4.8%) | 3 | 0/54 (0%) | 0 |
Vomiting | 5/69 (7.2%) | 7 | 2/42 (4.8%) | 3 | 5/54 (9.3%) | 5 |
General disorders | ||||||
Facial pain | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Fatigue | 3/69 (4.3%) | 4 | 3/42 (7.1%) | 4 | 2/54 (3.7%) | 2 |
Fever | 3/69 (4.3%) | 4 | 5/42 (11.9%) | 5 | 3/54 (5.6%) | 3 |
Irritability | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Multi-organ failure | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Non-cardiac chest pain | 2/69 (2.9%) | 2 | 3/42 (7.1%) | 3 | 2/54 (3.7%) | 2 |
Pain | 5/69 (7.2%) | 10 | 1/42 (2.4%) | 1 | 2/54 (3.7%) | 3 |
Hepatobiliary disorders | ||||||
Cholecystitis | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Immune system disorders | ||||||
Anaphylaxis | 2/69 (2.9%) | 2 | 2/42 (4.8%) | 2 | 1/54 (1.9%) | 1 |
Infections and infestations | ||||||
Abdominal infection | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 1 |
Anorectal infection | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Bladder infection | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 1 |
Catheter related infection | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Enterocolitis infectious | 5/69 (7.2%) | 6 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 2 |
Infections and infestations - Other, specify | 30/69 (43.5%) | 57 | 23/42 (54.8%) | 55 | 18/54 (33.3%) | 39 |
Infective myositis | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Lip infection | 1/69 (1.4%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Lung infection | 8/69 (11.6%) | 9 | 3/42 (7.1%) | 3 | 0/54 (0%) | 0 |
Mucosal infection | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Otitis media | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 2/54 (3.7%) | 2 |
Pancreas infection | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Paronychia | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Peripheral nerve infection | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Pharyngitis | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Scrotal infection | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Sepsis | 3/69 (4.3%) | 3 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Sinusitis | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 2/54 (3.7%) | 2 |
Skin infection | 3/69 (4.3%) | 4 | 2/42 (4.8%) | 2 | 2/54 (3.7%) | 3 |
Stoma site infection | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Upper respiratory infection | 3/69 (4.3%) | 3 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 1 |
Urinary tract infection | 4/69 (5.8%) | 5 | 2/42 (4.8%) | 2 | 1/54 (1.9%) | 1 |
Wound infection | 1/69 (1.4%) | 1 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||
Injury, poisoning and procedural complications - Other, specify | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Tracheal obstruction | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Vascular access complication | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Wound dehiscence | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Investigations | ||||||
Activated partial thromboplastin time prolonged | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Alanine aminotransferase increased | 25/69 (36.2%) | 71 | 22/42 (52.4%) | 47 | 27/54 (50%) | 73 |
Alkaline phosphatase increased | 3/69 (4.3%) | 3 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Aspartate aminotransferase increased | 10/69 (14.5%) | 19 | 11/42 (26.2%) | 15 | 14/54 (25.9%) | 30 |
Blood bilirubin increased | 8/69 (11.6%) | 8 | 3/42 (7.1%) | 3 | 3/54 (5.6%) | 3 |
Cholesterol high | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Creatinine increased | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
GGT increased | 3/69 (4.3%) | 3 | 3/42 (7.1%) | 7 | 7/54 (13%) | 19 |
Investigations - Other, specify | 1/69 (1.4%) | 1 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Lipase increased | 2/69 (2.9%) | 2 | 7/42 (16.7%) | 8 | 5/54 (9.3%) | 5 |
Lymphocyte count decreased | 0/69 (0%) | 0 | 4/42 (9.5%) | 4 | 0/54 (0%) | 0 |
Neutrophil count decreased | 44/69 (63.8%) | 121 | 29/42 (69%) | 82 | 36/54 (66.7%) | 92 |
Platelet count decreased | 30/69 (43.5%) | 52 | 20/42 (47.6%) | 37 | 22/54 (40.7%) | 33 |
Serum amylase increased | 0/69 (0%) | 0 | 2/42 (4.8%) | 2 | 2/54 (3.7%) | 2 |
Weight gain | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Weight loss | 5/69 (7.2%) | 5 | 4/42 (9.5%) | 5 | 1/54 (1.9%) | 1 |
White blood cell decreased | 19/69 (27.5%) | 27 | 16/42 (38.1%) | 34 | 18/54 (33.3%) | 45 |
Metabolism and nutrition disorders | ||||||
Acidosis | 2/69 (2.9%) | 2 | 2/42 (4.8%) | 2 | 2/54 (3.7%) | 3 |
Alkalosis | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Anorexia | 11/69 (15.9%) | 13 | 8/42 (19%) | 11 | 5/54 (9.3%) | 5 |
Dehydration | 1/69 (1.4%) | 1 | 5/42 (11.9%) | 5 | 3/54 (5.6%) | 5 |
Glucose intolerance | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Hypercalcemia | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Hyperglycemia | 18/69 (26.1%) | 36 | 11/42 (26.2%) | 12 | 9/54 (16.7%) | 18 |
Hyperkalemia | 9/69 (13%) | 10 | 2/42 (4.8%) | 3 | 3/54 (5.6%) | 3 |
Hypernatremia | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Hyperuricemia | 2/69 (2.9%) | 2 | 4/42 (9.5%) | 4 | 2/54 (3.7%) | 2 |
Hypoalbuminemia | 8/69 (11.6%) | 11 | 8/42 (19%) | 9 | 2/54 (3.7%) | 3 |
Hypocalcemia | 13/69 (18.8%) | 18 | 4/42 (9.5%) | 4 | 11/54 (20.4%) | 15 |
Hypoglycemia | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 3/54 (5.6%) | 3 |
Hypokalemia | 25/69 (36.2%) | 40 | 15/42 (35.7%) | 18 | 14/54 (25.9%) | 21 |
Hypomagnesemia | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 2/54 (3.7%) | 2 |
Hyponatremia | 12/69 (17.4%) | 12 | 8/42 (19%) | 10 | 8/54 (14.8%) | 10 |
Hypophosphatemia | 9/69 (13%) | 10 | 2/42 (4.8%) | 2 | 3/54 (5.6%) | 3 |
Obesity | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 2/54 (3.7%) | 7 |
Tumor lysis syndrome | 2/69 (2.9%) | 2 | 5/42 (11.9%) | 5 | 1/54 (1.9%) | 1 |
Musculoskeletal and connective tissue disorders | ||||||
Arthralgia | 2/69 (2.9%) | 2 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Avascular necrosis | 2/69 (2.9%) | 3 | 2/42 (4.8%) | 2 | 2/54 (3.7%) | 9 |
Back pain | 5/69 (7.2%) | 5 | 3/42 (7.1%) | 3 | 4/54 (7.4%) | 4 |
Bone pain | 1/69 (1.4%) | 1 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Generalized muscle weakness | 3/69 (4.3%) | 3 | 2/42 (4.8%) | 3 | 0/54 (0%) | 0 |
Muscle weakness left-sided | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Muscle weakness lower limb | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Myositis | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Neck pain | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 2/54 (3.7%) | 2 |
Pain in extremity | 3/69 (4.3%) | 5 | 4/42 (9.5%) | 5 | 3/54 (5.6%) | 3 |
Nervous system disorders | ||||||
Abducens nerve disorder | 1/69 (1.4%) | 3 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Ataxia | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 1 |
Cerebrospinal fluid leakage | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Cognitive disturbance | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Depressed level of consciousness | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Dizziness | 0/69 (0%) | 0 | 2/42 (4.8%) | 2 | 2/54 (3.7%) | 3 |
Dysphasia | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Encephalopathy | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Headache | 1/69 (1.4%) | 1 | 7/42 (16.7%) | 8 | 7/54 (13%) | 7 |
Hypoglossal nerve disorder | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Intracranial hemorrhage | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Nervous system disorders - Other, specify | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Neuralgia | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Seizure | 1/69 (1.4%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Syncope | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 1 |
Tremor | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Vagus nerve disorder | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Vasovagal reaction | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Psychiatric disorders | ||||||
Agitation | 1/69 (1.4%) | 1 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 1 |
Anxiety | 1/69 (1.4%) | 2 | 0/42 (0%) | 0 | 2/54 (3.7%) | 2 |
Confusion | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Depression | 2/69 (2.9%) | 2 | 2/42 (4.8%) | 2 | 0/54 (0%) | 0 |
Insomnia | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 1 |
Personality change | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Psychiatric disorders - Other, specify | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Suicidal ideation | 1/69 (1.4%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Renal and urinary disorders | ||||||
Acute kidney injury | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Chronic kidney disease | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Reproductive system and breast disorders | ||||||
Perineal pain | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Reproductive system and breast disorders - Other, specify | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Uterine hemorrhage | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||
Adult respiratory distress syndrome | 2/69 (2.9%) | 2 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Apnea | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Dyspnea | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Epistaxis | 3/69 (4.3%) | 5 | 1/42 (2.4%) | 2 | 1/54 (1.9%) | 1 |
Hypoxia | 8/69 (11.6%) | 10 | 3/42 (7.1%) | 3 | 5/54 (9.3%) | 5 |
Pharyngeal mucositis | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Pharyngolaryngeal pain | 3/69 (4.3%) | 3 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Pleural effusion | 6/69 (8.7%) | 7 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Pneumonitis | 1/69 (1.4%) | 1 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders - Other, specify | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 1 |
Skin and subcutaneous tissue disorders | ||||||
Pain of skin | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Pruritus | 1/69 (1.4%) | 1 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Purpura | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Rash maculo-papular | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Skin and subcutaneous tissue disorders - Other, specify | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Urticaria | 0/69 (0%) | 0 | 1/42 (2.4%) | 1 | 0/54 (0%) | 0 |
Vascular disorders | ||||||
Capillary leak syndrome | 0/69 (0%) | 0 | 0/42 (0%) | 0 | 1/54 (1.9%) | 1 |
Hematoma | 1/69 (1.4%) | 1 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Hypertension | 3/69 (4.3%) | 3 | 1/42 (2.4%) | 1 | 1/54 (1.9%) | 1 |
Hypotension | 4/69 (5.8%) | 4 | 4/42 (9.5%) | 5 | 3/54 (5.6%) | 3 |
Vascular disorders - Other, specify | 2/69 (2.9%) | 2 | 0/42 (0%) | 0 | 0/54 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Must obtain sponsor approval.
Results Point of Contact
Name/Title | Results Reporting Coordinator |
---|---|
Organization | Children's Oncology Group |
Phone | 626-447-0064 |
resultsreportingcoordinator@childrensoncologygroup.org |
- AALL07P4
- NCI-2009-00317
- CDR0000594340
- 08-606
- COG-AALL07P4
- AALL07P4
- AALL07P4
- U10CA098543