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Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02393859
Recruitment Status : Active, not recruiting
First Posted : March 20, 2015
Results First Posted : July 13, 2020
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia, Acute Lymphoblastic
Interventions Drug: Blinatumomab
Drug: Dexamethasone
Drug: Vincrisitne
Drug: Daunorubicin
Drug: Methotrexate
Drug: Ifosfamide
Drug: PEG-asparaginase
Drug: Erwinia-asparaginase
Enrollment 108
Recruitment Details

This study was conducted at 47 centers across 13 countries (Europe, Australia, Israel). The first participant was enrolled on 10 November 2015.The last participant enrolled on 30 August 2019.

Data cutoff for the primary analysis data presented here was 17 July 2019.

Pre-assignment Details

After a 3-week screening period, participants were enrolled and randomized 1:1 into 1 of 2 treatment groups: High Risk Consolidation 3 (HC3) or Blinatumomab.

Randomization was stratified by age and bone marrow/minimal residual disease (MRD) status.

Arm/Group Title HC3 Chemotherapy Blinatumomab
Hide Arm/Group Description One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day intravenous [IV] on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or intramuscularly [IM] on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses). One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
Period Title: Overall Study
Started 54 54
Completed 0 0
Not Completed 54 54
Reason Not Completed
Decision by Sponsor             1             1
Withdrawal by Subject             5             2
Death             16             8
Continuing Study             32             43
Arm/Group Title HC3 Chemotherapy Blinatumomab Total
Hide Arm/Group Description One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day IV on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses). One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI). Total of all reporting groups
Overall Number of Baseline Participants 54 54 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 54 participants 108 participants
6.7  (4.4) 7.3  (4.4) 7.0  (4.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 54 participants 108 participants
Female
32
  59.3%
24
  44.4%
56
  51.9%
Male
22
  40.7%
30
  55.6%
52
  48.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 54 participants 108 participants
Hispanic or Latino
3
   5.6%
1
   1.9%
4
   3.7%
Not Hispanic or Latino
51
  94.4%
53
  98.1%
104
  96.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants 54 participants 108 participants
White 43 50 93
Other, Not Specified 5 3 8
Asian 3 1 4
Black or African American 3 0 3
Stratification Factor: Age Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants 54 participants 108 participants
1 to 9 years 38 39 77
Other (< 1 year and > 9 years) 16 15 31
Stratification Factor: Marrow/Minimal Residual Disease (MRD)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants 54 participants 108 participants
M1 Marrow + MRD level ≥ 10^-3 16 15 31
M1 Marrow + MRD level < 10^-3 34 35 69
M2 Marrow 4 4 8
[1]
Measure Description: M1: representative bone marrow aspirate or biopsy with blasts < 5%, with satisfactory cellularity and with regenerating hematopoiesis; M2: Representative bone marrow aspirate or biopsy with ≥ 5% and < 25% blasts; MRD=residual disease levels ≥ 10^-3 or < 10^-3, by polymerase chain reaction (PCR) or flow cytometry.
1.Primary Outcome
Title Kaplan Meier Estimate: Event-Free Survival (EFS)
Hide Description

EFS is calculated from the time of randomization until the date of relapse or M2 marrow (representative bone marrow aspirate or biopsy with ≥ 5% and < 25% blasts) after having achieved a complete remission (CR), failure to achieve a CR at the end of treatment, second malignancy, or death due to any cause, whichever occurs first. Participants who failed to achieve a CR following treatment with investigational product (IP) or who died before the disease assessment at the end of treatment were considered treatment failures and assigned an EFS duration of 1 day. Participants still alive and event-free were censored on their last disease assessment date.

Participants were said to be in CR when they had the following:

  • M1 marrow
  • Peripheral blood without blasts
  • Absence of extramedullary leukemic involvement

Months are calculated as days from randomization date to event/censor date, divided by 30.5.

Time Frame As of the data cutoff date (17 July 2019), overall median follow-up time for EFS was 22.4 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received.
Arm/Group Title HC3 Chemotherapy Blinatumomab
Hide Arm/Group Description:
One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day IV on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses).
One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
Overall Number of Participants Analyzed 54 54
Median (95% Confidence Interval)
Unit of Measure: months
7.4
(4.5 to 12.7)
NA [1] 
(12.0 to NA)
[1]
NA=not estimable (median EFS and upper confidence interval were not reached at time of data cutoff)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HC3 Chemotherapy, Blinatumomab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Stratification factors were: age (1 to 9 years vs other [< 1 year and > 9 years]), and marrow/MRD status (M1 with MRD level < 10^-3 vs M1 with MRD level ≥ 10^-3 vs M2).
Method Stratified log-rank test
Comments [Not Specified]
Other Statistical Analysis Normal score: -11.54. (A normal score < 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HC3 Chemotherapy, Blinatumomab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Unstratified log-rank test
Comments [Not Specified]
Other Statistical Analysis Normal score: -11.16. (A normal score < 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.)
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection HC3 Chemotherapy, Blinatumomab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified hazard ratio (HR)
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.19 to 0.66
Estimation Comments Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR < 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection HC3 Chemotherapy, Blinatumomab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Unstratified hazard ratio (HR)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.22 to 0.70
Estimation Comments Cox proportional hazard model. (HR < 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection HC3 Chemotherapy, Blinatumomab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified HR w/time-dependent covariate
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.20 to 0.64
Estimation Comments Cox proportional hazard model including time from randomization to allogeneic hematopoietic stem cell transplant. Stratification factors: age and marrow/MRD status. (HR <1.0=lower average event rate and longer EFS for blinatumomab relative to HC3.)
2.Secondary Outcome
Title Kaplan Meier Estimate: Overall Survival (OS)
Hide Description

Overall survival (OS) was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive.

Months were calculated as days from randomization date to event/censor date, divided by 30.5.

Time Frame As of the data cutoff date (17 July 2019), overall median follow-up time for OS was 19.5 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received.
Arm/Group Title HC3 Chemotherapy Blinatumomab
Hide Arm/Group Description:
One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day IV on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses).
One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
Overall Number of Participants Analyzed 54 54
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(15.7 to NA)
NA [2] 
(NA to NA)
[1]
NA=not estimable (median OS and upper confidence interval were not reached at time of data cutoff)
[2]
NA=not estimable (median OS and confidence intervals were not reached at time of data cutoff)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HC3 Chemotherapy, Blinatumomab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments Stratification factors were: age (1 to 9 years vs other [< 1 year and > 9 years]), and marrow/MRD status (M1 with MRD level < 10^-3 vs M1 with MRD level ≥ 10^-3 vs M2).
Method Stratified log-rank test
Comments [Not Specified]
Other Statistical Analysis Normal score: -4.84. (A normal score < 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HC3 Chemotherapy, Blinatumomab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments [Not Specified]
Method Unstratified log-rank test
Comments [Not Specified]
Other Statistical Analysis Normal score: -5.00. (A normal score < 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.)
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection HC3 Chemotherapy, Blinatumomab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified hazard ratio (HR)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.18 to 1.01
Estimation Comments Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR < 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection HC3 Chemotherapy, Blinatumomab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Unstratified hazard ratio (HR)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.18 to 0.99
Estimation Comments Cox proportional hazard model. (HR < 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)
3.Secondary Outcome
Title Percentage of Participants With an MRD Response Within 29 Days of Treatment Initiation
Hide Description

At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory.

MRD response was defined as MRD level < 10^-4, by polymerase chain reaction (PCR) or flow cytometry, at the end of treatment with study drug. Participants who were part of the MRD Evaluable Set and were missing the end of treatment (Cycle 1 Day 29) assessment for a respective MRD assessment method were considered not to have achieved a response.

Time Frame Up to End of Treatment (Cycle 1, Day 29). Data cutoff date was 17 July 2019.
Hide Outcome Measure Data
Hide Analysis Population Description
MRD Evaluable Set: participants for whom a baseline MRD marker can be found with either the MRD assessment methods of PCR or flow cytometry.
Arm/Group Title HC3 Chemotherapy Blinatumomab
Hide Arm/Group Description:
One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day IV on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses).
One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
Overall Number of Participants Analyzed 54 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
MRD Response by PCR Number Analyzed 48 participants 49 participants
54.2
(39.2 to 68.6)
89.8
(77.8 to 96.6)
MRD Response by Flow Cytometry Number Analyzed 53 participants 53 participants
60.4
(46.0 to 73.5)
90.6
(79.3 to 96.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HC3 Chemotherapy, Blinatumomab
Comments MRD response by PCR
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other [< 1 year and > 9 years]), and marrow/MRD status (M1 with MRD level < 10^-3 vs M1 with MRD level ≥ 10^-3 vs M2).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HC3 Chemotherapy, Blinatumomab
Comments MRD response by flow cytometry
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other [< 1 year and > 9 years]), and marrow/MRD status (M1 with MRD level < 10-3 vs M1 with MRD level ≥ 10-3 vs M2).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Cumulative Incidence of Relapse (CIR)
Hide Description

CIR estimate, presented as median months to relapse, calculated from date of achievement of first CR, using the cumulative incidence method (Fine JP, Gray RJ:1999). Deaths prior to relapse not considered related to an otherwise undocumented relapse were treated as a competing risk. Participants still alive without a date of relapse were censored at the time of last follow-up.

Relapse=presence of ≥1 of the following:

  • isolated bone marrow relapse (M3 marrow [representative bone marrow aspirate or biopsy with ≥25% blasts] in the absence of extramedullary involvement)
  • combined bone marrow relapse (M2 [representative bone marrow aspirate or biopsy with ≥5% and <25% blasts] or M3 marrow and ≥1 extramedullary manifestation of acute lymphoblastic leukemia)
  • central nervous system extramedullary relapse
  • testicular extramedullary relapse
  • extramedullary relapse at other sites

Months were calculated as days from randomization to event/censor date, divided by 30.5.

Time Frame As of data cutoff date (17 July 2019), the overall maximum follow-up time was 44.1 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received.
Arm/Group Title HC3 Chemotherapy Blinatumomab
Hide Arm/Group Description:
One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day IV on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses).
One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
Overall Number of Participants Analyzed 54 54
Median (95% Confidence Interval)
Unit of Measure: months
7.9
(5.8 to 23.1)
NA [1] 
(NA to NA)
[1]
NA=not estimable (median CIR and confidence intervals were not reached at time of data cutoff)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HC3 Chemotherapy, Blinatumomab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
0.15 to 0.53
Estimation Comments The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR < 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HC3 Chemotherapy, Blinatumomab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified hazard ratio (HR)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
0.13 to 0.46
Estimation Comments The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR < 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.) Stratification factors are age and marrow/MRD status.
5.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)
Hide Description Adverse event (AE): any untoward medical occurrence. Serious AE: an AE meeting at least 1 of the following serious criteria: fatal; life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event. Severity was graded according to the Common Terminology Criteria for AEs (CTCAE) version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Investigational product (IP) in the HC3 arm refers to dexamethasone, methotrexate, daunorubicin, erwinase, ifosfamide, asparaginase, and vincristine, and in the blinatumomab arm refers to blinatumomab. Treatment-related refers to the assessment of a relationship between IP and the event.
Time Frame From first dose of IP through the last dose of IP (up to Day 29) plus 30 days. Data cutoff date was 17 July 2019.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: who received protocol-specified therapy analyzed according to the treatment they received.
Arm/Group Title HC3 Chemotherapy Blinatumomab
Hide Arm/Group Description:
One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day IV on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses).
One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
Overall Number of Participants Analyzed 51 54
Measure Type: Number
Unit of Measure: participants
TEAEs 49 54
TEAEs Grade ≥ 3 42 31
Serious TEAEs 22 13
Fatal TEAEs 0 0
TEAEs Leading to Discontinuation of IP 0 2
TEAEs Leading to Interruption of IP 2 6
TRAEs 40 45
TRAEs Grade ≥ 3 32 9
Serious TRAEs 14 9
Fatal TRAEs 0 0
TRAEs Leading to Discontinuation of IP 0 2
TRAEs Leading to Interruption of IP 2 5
6.Secondary Outcome
Title Number of Participants With TEAEs of Interest
Hide Description TEAEs of interest included capillary leak system (CLS), cytokine release syndrome (CRS), decreased immunoglobulins (DI), elevated liver enzymes (ELE), embolic and thrombotic events (ETE), infections (INF), infusion reactions without considering duration (IRWCD), medication errors (ME), neurologic events (NE), neutropenia and febrile neutropenia (NFN), pancreatitis (PNC), tumor lysis syndrome (TLS), leukoencephalopathy (LE), immunogenicity (IM). Severity was graded according to the CTCAE version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.
Time Frame From first dose of IP through the last dose of IP (up to Day 29) plus 30 days. Data cutoff date was 17 July 2019.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: who received protocol-specified therapy analyzed according to the treatment they received.
Arm/Group Title HC3 Chemotherapy Blinatumomab
Hide Arm/Group Description:
One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day IV on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses).
One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
Overall Number of Participants Analyzed 51 54
Measure Type: Number
Unit of Measure: participants
CLS Events 1 0
CLS Events Grade ≥ 3 1 0
Serious CLS Events 1 0
Fatal CLS Events 0 0
CLS Events Leading to Discontinuation of IP 0 0
CLS Events Leading to Interruption of IP 0 0
CRS Events 1 2
CRS Events Grade ≥ 3 0 0
Serious CRS Events 0 0
Fatal CRS Events 0 0
CRS Events Leading to Discontinuation of IP 0 0
CRS Events Leading to Interruption of IP 0 0
DI Events 6 9
DI Events Grade ≥ 3 1 1
Serious DI Events 0 1
Fatal DI Events 0 0
DI Events Leading to Discontinuation of IP 0 0
DI Events Leading to Interruption of IP 0 0
ELE Events 15 7
ELE Events Grade ≥ 3 9 3
Serious ELE Events 1 0
Fatal ELE Events 0 0
ELE Events Leading to Discontinuation of IP 0 0
ELE Events Leading to Interruption of IP 0 0
ETE Events 0 4
ETE Events Grade ≥ 3 0 2
Serious ETE Events 0 0
Fatal ETE Events 0 0
ETE Events Leading to Discontinuation of IP 0 0
ETE Events Leading to Interruption of IP 0 0
INF Events 16 23
INF Events Grade ≥ 3 5 10
Serious INF Events 4 3
Fatal INF Events 0 0
IFN Events Leading to Discontinuation of IP 0 0
IFN Events Leading to Interruption of IP 0 0
IRWCD Events 4 37
IRWCD Events Grade ≥ 3 0 2
Serious IRWCD Events 0 1
Fatal IRWCD Events 0 0
IRWCD Events Leading to Discontinuation of IP 0 0
IRWCD Events Leading to Interruption of IP 0 0
ME Events 0 1
ME Events Grade ≥ 3 0 0
Serious ME Events 0 1
Fatal ME Events 0 0
ME Events Leading to Discontinuation of IP 0 0
ME Events Leading to Interruption of IP 0 1
NE Events 15 26
NE Events Grade ≥ 3 1 3
Serious NE Events 1 5
Fatal NE Events 0 0
NE Events Leading to Discontinuation of IP 0 2
NE Events Leading to Interruption of IP 1 3
NFN Events 28 12
NFN Events Grade ≥ 3 27 11
Serious NFN Events 12 0
Fatal NFN Events 0 0
NFN Events Leading to Discontinuation of IP 0 0
NFN Events Leading to Interruption of IP 0 0
PNC Events 1 0
PNC Events Grade ≥ 3 1 0
Serious PNC Events 1 0
Fatal PNC Events 0 0
PNC Events Leading to Discontinuation of IP 0 0
PNC Events Leading to Interruption of IP 0 0
Tumour Lysis Syndrome Events 0 0
Leukoencephalopathy Events 0 0
Immunogenicity Events 0 0
7.Secondary Outcome
Title Number of Participants With Shifts From Baseline Grade 0 or 1 to Worst Postbaseline Grade 3 or 4 Clinical Chemistry and Hematology Values
Hide Description Severity was graded according to the CTCAE version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Increases (↑) or decreases (↓) in laboratory value grades (Gr) from baseline (BL) to worst postbaseline (→ PB) grade are presented. NA=not available.
Time Frame Up to Day 29 (± 2 days). Data cutoff date was 17 July 2019.
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Hide Analysis Population Description
Safety Analysis Set: who received protocol-specified therapy analyzed according to the treatment they received.
Arm/Group Title HC3 Chemotherapy Blinatumomab
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One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day IV on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses).
One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
Overall Number of Participants Analyzed 51 54
Measure Type: Number
Unit of Measure: participants
Potassium ↑ BL Gr 0 → PB Gr 3 0 1
Potassium ↓ BL Gr NA → PB Gr 3 2 1
Potassium ↓ BL Gr NA → PB Gr 4 1 0
Potassium ↓ BL Gr 0 → PB Gr 3 4 5
Potassium ↓ BL Gr 0 → PB Gr 4 1 1
Albumin ↓ BL Gr 0 → PB Gr 3 0 1
Corrected Calcium ↓ BL Gr 0 → PB Gr 4 1 1
Alanine Aminotransferase ↑ BL Gr 0 → PB Gr 3 1 0
Alanine Aminotransferase ↑ BL Gr 1 → PB Gr 3 9 5
Aspartate Aminotransferase ↑ BL Gr NA → PB Gr 3 1 0
Aspartate Aminotransferase ↑ BL Gr 0 → PB Gr 3 2 0
Aspartate Aminotransferase ↑ BL Gr 1 → PB Gr 3 4 1
Aspartate Aminotransferase ↑ BL Gr 1 → PB Gr 4 1 0
Gamma-Glutamyl Transferase ↑ BL Gr NA → PB Gr 3 0 1
Gamma-Glutamyl Transferase ↑ BL Gr 0 → PB Gr 3 3 4
Gamma-Glutamyl Transferase ↑ BL Gr 1 → PB Gr 3 5 2
Gamma-Glutamyl Transferase ↑ BL Gr 1 → PB Gr 4 0 3
Amylase ↑ BL Gr 0 → PB Gr 3 1 1
Amylase ↑ BL Gr 0 → PB Gr 4 1 0
Amylase ↑ BL Gr 1 → PB Gr 3 0 1
Lipase ↑ BL Gr 0 → PB Gr 3 3 1
Lipase ↑ BL Gr 0 → PB Gr 4 1 2
Bilirubin ↑ BL Gr 0 → PB Gr 3 2 1
Bilirubin ↑ BL Gr 0 → PB Gr 4 1 0
Hemoglobin ↓ BL Gr 0 → PB Gr 3 1 0
Hemoglobin ↓ BL Gr 1 → PB Gr 3 4 1
Platelets ↓ BL Gr 0 → PB Gr 3 5 6
Platelets ↓ BL Gr 1 → PB Gr 3 1 1
Platelets ↓ BL Gr 0 → PB Gr 4 13 5
Platelets ↓ BL Gr 1 → PB Gr 4 8 2
Leukocytes ↑ BL Gr 0 → PB Gr 3 1 0
Leukocytes ↓ BL Gr 0 → PB Gr 3 2 0
Leukocytes ↓ BL Gr 1 → PB Gr 3 4 4
Leukocytes ↓ BL Gr 0 → PB Gr 4 4 0
Leukocytes ↓ BL Gr 1 → PB Gr 4 6 1
Neutrophils ↓ BL Gr 0 → PB Gr 3 4 10
Neutrophils ↓ BL Gr 0 → PB Gr 4 22 3
Lymphocytes ↑ BL Gr 0 → PB Gr 3 0 1
Lymphocytes ↓ BL Gr 0 → PB Gr 3 1 3
Lymphocytes ↓ BL Gr 1 → PB Gr 3 0 1
Lymphocytes ↓ BL Gr 0 → PB Gr 4 1 1
Lymphocytes ↓ BL Gr 1 → PB Gr 4 1 2
8.Secondary Outcome
Title Kaplan-Meier Estimate of 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
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The analysis of 100-day mortality after alloHSCT was assessed for participants who received an alloHSCT while in remission and did not receive any additional anti-leukemic treatment. 100-day mortality after alloHSCT was calculated relative to the date of alloHSCT.

The 100-day mortality rate after alloHSCT was defined as the percentage of participants having died up to 100 days after alloHSCT, estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants still alive were censored at the date they were last known to be alive.

Time Frame From the date of alloHSCT until the data cut-off date of 17 July 2019; median follow up time was 652.0 days for blinatumomab and 541.0 days for HC3.
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HSCT Analysis Set: participants who underwent an HSCT while in remission without any other anti-leukemic therapy.
Arm/Group Title HC3 Chemotherapy Blinatumomab
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One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day IV on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses).
One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
Overall Number of Participants Analyzed 38 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.6
(1.4 to 20.5)
4.2
(1.1 to 15.6)
9.Secondary Outcome
Title Number of Participants With Anti-Blinatumomab Antibodies Postbaseline (Blinatumomab Arm Only)
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Participants receiving blinatumomab had blood samples analyzed for binding antibodies. Samples testing positive for binding antibodies were also tested for neutralizing antibodies.

Participants who were binding antibody-positive or neutralizing antibody-positive post-baseline with a negative or no result at baseline are presented.

Time Frame Day 1 to Day 29. Data cutoff date was 17 July 2019.
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Safety Analysis Set: participants who received protocol-specified therapy analyzed according to the treatment they received. Participants in the blinatumumab arm with a post-baseline result.
Arm/Group Title Blinatumomab
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One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: participants
Binding Antibody Positive 0
Neutralizing Antibody Positive 0
10.Secondary Outcome
Title Pharmacokinetics: Concentration at Steady State (Css)
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Time Frame Day 1: at least 10 hours after infusion start and up to 24 hours; Day 15
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Pharmacokinetic (PK) Analysis Set: participants who received any infusion of blinatumomab and had at least one PK sample collected.
Arm/Group Title Blinatumomab
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One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: pg/mL
921  (1010)
11.Secondary Outcome
Title Pharmacokinetics: Clearance (CL)
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Time Frame Day 1: at least 10 hours after infusion start and up to 24 hours; Day 15
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PK) Analysis Set: participants who received any infusion of blinatumomab and had at least one PK sample collected.
Arm/Group Title Blinatumomab
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One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: L/hr/m^2
0.998  (0.450)
Time Frame From first dose of IP through the last dose of IP (up to Day 29) plus 30 days. Data cutoff date was 17 July 2019.
Adverse Event Reporting Description All-cause mortality is reported for all participants enrolled/randomized in the study (from the time of enrollment/randomization). Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP (from the time of first dose of IP).
 
Arm/Group Title HC3 Chemotherapy Blinatumomab
Hide Arm/Group Description One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m^2/day IV on Days 1-6), vincrisitne (1.5 mg/m^2/day IV on Days 1 and 6), daunorubicin (30 mg/m^2 IV over 24 hours on Day 5), methotrexate (1 g/m^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m^2 IV for 1 hour on Days 2-4), and pegylated [PEG]-asparaginase (1000 U/m^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m^2 IV or IM every 48 hours for a total of 6 doses). One 4-week cycle of blinatumomab 15 μg/m^2/day as a continuous intravenous infusion (CIVI).
All-Cause Mortality
HC3 Chemotherapy Blinatumomab
Affected / at Risk (%) Affected / at Risk (%)
Total   16/54 (29.63%)   8/54 (14.81%) 
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HC3 Chemotherapy Blinatumomab
Affected / at Risk (%) Affected / at Risk (%)
Total   22/51 (43.14%)   13/54 (24.07%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  9/51 (17.65%)  0/54 (0.00%) 
Leukopenia  1  1/51 (1.96%)  0/54 (0.00%) 
Neutropenia  1  3/51 (5.88%)  0/54 (0.00%) 
Thrombocytopenia  1  2/51 (3.92%)  0/54 (0.00%) 
Gastrointestinal disorders     
Pancreatitis acute  1  1/51 (1.96%)  0/54 (0.00%) 
Stomatitis  1  2/51 (3.92%)  1/54 (1.85%) 
General disorders     
Pyrexia  1  0/51 (0.00%)  1/54 (1.85%) 
Hepatobiliary disorders     
Hepatotoxicity  1  1/51 (1.96%)  0/54 (0.00%) 
Hypertransaminasaemia  1  1/51 (1.96%)  0/54 (0.00%) 
Infections and infestations     
Bronchitis  1  1/51 (1.96%)  0/54 (0.00%) 
Clostridium difficile colitis  1  1/51 (1.96%)  0/54 (0.00%) 
Device related infection  1  1/51 (1.96%)  0/54 (0.00%) 
Escherichia bacteraemia  1  1/51 (1.96%)  0/54 (0.00%) 
Herpes virus infection  1  0/51 (0.00%)  1/54 (1.85%) 
Klebsiella infection  1  0/51 (0.00%)  1/54 (1.85%) 
Perineal cellulitis  1  0/51 (0.00%)  1/54 (1.85%) 
Septic shock  1  1/51 (1.96%)  0/54 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  0/51 (0.00%)  1/54 (1.85%) 
Pneumothorax traumatic  1  1/51 (1.96%)  0/54 (0.00%) 
Investigations     
Blood immunoglobulin G decreased  1  0/51 (0.00%)  1/54 (1.85%) 
Body temperature increased  1  0/51 (0.00%)  1/54 (1.85%) 
Lipase increased  1  1/51 (1.96%)  0/54 (0.00%) 
Neurological examination abnormal  1  0/51 (0.00%)  1/54 (1.85%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  0/51 (0.00%)  1/54 (1.85%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/51 (1.96%)  0/54 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute lymphocytic leukaemia recurrent  1  1/51 (1.96%)  0/54 (0.00%) 
Nervous system disorders     
Headache  1  1/51 (1.96%)  0/54 (0.00%) 
Nervous system disorder  1  0/51 (0.00%)  1/54 (1.85%) 
Neurological symptom  1  0/51 (0.00%)  2/54 (3.70%) 
Seizure  1  0/51 (0.00%)  2/54 (3.70%) 
Surgical and medical procedures     
Catheter placement  1  0/51 (0.00%)  1/54 (1.85%) 
Vascular disorders     
Capillary leak syndrome  1  1/51 (1.96%)  0/54 (0.00%) 
Hypotension  1  0/51 (0.00%)  1/54 (1.85%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HC3 Chemotherapy Blinatumomab
Affected / at Risk (%) Affected / at Risk (%)
Total   47/51 (92.16%)   54/54 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  23/51 (45.10%)  12/54 (22.22%) 
Febrile neutropenia  1  4/51 (7.84%)  3/54 (5.56%) 
Leukopenia  1  3/51 (5.88%)  0/54 (0.00%) 
Neutropenia  1  13/51 (25.49%)  5/54 (9.26%) 
Thrombocytopenia  1  11/51 (21.57%)  4/54 (7.41%) 
Congenital, familial and genetic disorders     
Aplasia  1  4/51 (7.84%)  2/54 (3.70%) 
Gastrointestinal disorders     
Abdominal pain  1  11/51 (21.57%)  7/54 (12.96%) 
Abdominal pain upper  1  3/51 (5.88%)  4/54 (7.41%) 
Constipation  1  7/51 (13.73%)  5/54 (9.26%) 
Diarrhoea  1  9/51 (17.65%)  11/54 (20.37%) 
Nausea  1  9/51 (17.65%)  22/54 (40.74%) 
Oral pain  1  3/51 (5.88%)  1/54 (1.85%) 
Stomatitis  1  27/51 (52.94%)  9/54 (16.67%) 
Vomiting  1  11/51 (21.57%)  16/54 (29.63%) 
General disorders     
Fatigue  1  2/51 (3.92%)  3/54 (5.56%) 
Mucosal inflammation  1  4/51 (7.84%)  9/54 (16.67%) 
Pyrexia  1  10/51 (19.61%)  43/54 (79.63%) 
Hepatobiliary disorders     
Hypertransaminasaemia  1  4/51 (7.84%)  1/54 (1.85%) 
Immune system disorders     
Hypogammaglobulinaemia  1  2/51 (3.92%)  6/54 (11.11%) 
Immunodeficiency  1  0/51 (0.00%)  4/54 (7.41%) 
Infections and infestations     
Nasopharyngitis  1  1/51 (1.96%)  3/54 (5.56%) 
Paronychia  1  0/51 (0.00%)  3/54 (5.56%) 
Rhinitis  1  5/51 (9.80%)  1/54 (1.85%) 
Investigations     
Alanine aminotransferase increased  1  7/51 (13.73%)  4/54 (7.41%) 
Antithrombin III decreased  1  3/51 (5.88%)  1/54 (1.85%) 
Aspartate aminotransferase increased  1  5/51 (9.80%)  2/54 (3.70%) 
Fluid balance positive  1  3/51 (5.88%)  2/54 (3.70%) 
Neutrophil count decreased  1  2/51 (3.92%)  5/54 (9.26%) 
Platelet count decreased  1  8/51 (15.69%)  7/54 (12.96%) 
White blood cell count decreased  1  1/51 (1.96%)  4/54 (7.41%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/51 (1.96%)  3/54 (5.56%) 
Fluid overload  1  0/51 (0.00%)  4/54 (7.41%) 
Hypokalaemia  1  5/51 (9.80%)  6/54 (11.11%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/51 (7.84%)  0/54 (0.00%) 
Back pain  1  4/51 (7.84%)  3/54 (5.56%) 
Pain in extremity  1  5/51 (9.80%)  2/54 (3.70%) 
Nervous system disorders     
Headache  1  8/51 (15.69%)  19/54 (35.19%) 
Tremor  1  0/51 (0.00%)  5/54 (9.26%) 
Psychiatric disorders     
Agitation  1  1/51 (1.96%)  4/54 (7.41%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/51 (1.96%)  4/54 (7.41%) 
Epistaxis  1  7/51 (13.73%)  5/54 (9.26%) 
Oropharyngeal pain  1  3/51 (5.88%)  2/54 (3.70%) 
Skin and subcutaneous tissue disorders     
Erythema  1  2/51 (3.92%)  6/54 (11.11%) 
Petechiae  1  0/51 (0.00%)  3/54 (5.56%) 
Pruritus  1  5/51 (9.80%)  6/54 (11.11%) 
Rash  1  4/51 (7.84%)  7/54 (12.96%) 
Rash maculo-papular  1  0/51 (0.00%)  3/54 (5.56%) 
Urticaria  1  0/51 (0.00%)  3/54 (5.56%) 
Vascular disorders     
Haematoma  1  3/51 (5.88%)  1/54 (1.85%) 
Hypertension  1  4/51 (7.84%)  7/54 (12.96%) 
Hypotension  1  4/51 (7.84%)  6/54 (11.11%) 
1
Term from vocabulary, MedDRA 22.1
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.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
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Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
EMail: medinfo@amgen.com
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02393859    
Other Study ID Numbers: 20120215
2014-002476-92 ( EudraCT Number )
First Submitted: March 16, 2015
First Posted: March 20, 2015
Results First Submitted: June 24, 2020
Results First Posted: July 13, 2020
Last Update Posted: August 5, 2020