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A Study of Pomalidomide Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors

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: NCT03257631
Recruitment Status : Active, not recruiting
First Posted : August 22, 2017
Results First Posted : December 10, 2019
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Central Nervous System Neoplasms
Medulloblastoma
Intervention Drug: Pomalidomide
Enrollment 53
Recruitment Details Participants were enrolled at 18 sites in France, Italy, Spain, UK, and the USA. The study consisted of 4 groups, for each of the following primary brain tumor types: diffuse intrinsic pontine glioma (DIPG), ependymoma, high-grade glioma, and medulloblastoma. The study is currently ongoing; results are reported as of 15 March 2019 data cutoff date.
Pre-assignment Details In stage 1 approximately 9 participants were to be enrolled in parallel to each group. If two or more participants in a group achieved an objective response or long-term stable disease within the first 6 cycles of treatment (within the first 3 cycles for DIPG) an additional 11 participants were to be enrolled in that group.
Arm/Group Title Diffuse Intrinsic Pontine Glioma Ependymoma High-grade Glioma Medulloblastoma
Hide Arm/Group Description Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first. Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first. Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first. Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Period Title: Overall Study
Started 11 9 23 10
Received Study Drug 11 9 22 10
Completed 0 0 0 0
Not Completed 11 9 23 10
Reason Not Completed
Death             8             5             13             5
Progressive Disease             0             0             1             0
Withdrawal by Parent/Guardian             0             2             4             1
Lost to Follow-up             0             0             1             0
Still on Study             3             2             4             4
Arm/Group Title Diffuse Intrinsic Pontine Glioma Ependymoma High-grade Glioma Medulloblastoma Total
Hide Arm/Group Description Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first. Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first. Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first. Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first. Total of all reporting groups
Overall Number of Baseline Participants 11 9 23 10 53
Hide Baseline Analysis Population Description
The intent-to-treat population includes all enrolled participants, regardless of whether they received any treatment or not.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants 9 participants 23 participants 10 participants 53 participants
7.0
(4 to 12)
12.0
(4 to 15)
14.0
(5 to 18)
10.0
(4 to 17)
12.0
(4 to 18)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 23 participants 10 participants 53 participants
≥ 1 to < 6 years
1
   9.1%
2
  22.2%
1
   4.3%
1
  10.0%
5
   9.4%
≥ 6 to < 12 years
9
  81.8%
1
  11.1%
5
  21.7%
6
  60.0%
21
  39.6%
≥ 12 years
1
   9.1%
6
  66.7%
17
  73.9%
3
  30.0%
27
  50.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 23 participants 10 participants 53 participants
Female
4
  36.4%
4
  44.4%
8
  34.8%
3
  30.0%
19
  35.8%
Male
7
  63.6%
5
  55.6%
15
  65.2%
7
  70.0%
34
  64.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 23 participants 10 participants 53 participants
Hispanic or Latino
4
  36.4%
0
   0.0%
6
  26.1%
1
  10.0%
11
  20.8%
Not Hispanic or Latino
7
  63.6%
9
 100.0%
13
  56.5%
8
  80.0%
37
  69.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
4
  17.4%
1
  10.0%
5
   9.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 23 participants 10 participants 53 participants
American Indian or Alaskan Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   9.1%
0
   0.0%
2
   8.7%
0
   0.0%
3
   5.7%
Black or African American
0
   0.0%
0
   0.0%
2
   8.7%
0
   0.0%
2
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
10
  90.9%
9
 100.0%
11
  47.8%
8
  80.0%
38
  71.7%
Not Collected or Reported
0
   0.0%
0
   0.0%
5
  21.7%
2
  20.0%
7
  13.2%
Other
0
   0.0%
0
   0.0%
3
  13.0%
0
   0.0%
3
   5.7%
1.Primary Outcome
Title Percentage of Participants With an Objective Response or Long-term Stable Disease
Hide Description Objective response and long-term stable disease rate was defined as the percentage of participants who achieved either an objective response, defined as a complete response (CR) or partial response (PR) in the first 6 cycles of treatment (or within 3 cycles for DIPG), or long-term stable disease (SD) defined as SD maintained for ≥ 6 cycles (≥ 3 cycles for DIPG), measured from first dose date. Disease assessments were based on magnetic resonance imaging (MRI) assessed by an independent central review. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions compared to baseline, and/or persistence of non-target lesions with no progression or decrease in size. SD: A decrease of < 50% or an increase of < 25% in the size of measurable lesions and no evidence of new lesions, response does not meet the criteria for CR, PR, or progressive disease, and/or the persistence of non-target lesions with no progression or decrease in size.
Time Frame 6 months (first 6 cycles) or 3 months (first 3 cycles) for participants in the DIPG group
Hide Outcome Measure Data
Hide Analysis Population Description
The response population consisted of all participants enrolled who met eligibility criteria relevant to efficacy, and received at least one cycle of pomalidomide if therapy was not discontinued earlier due to progressive disease (PD).
Arm/Group Title Diffuse Intrinsic Pontine Glioma Ependymoma High-grade Glioma Medulloblastoma
Hide Arm/Group Description:
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Overall Number of Participants Analyzed 9 9 19 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 33.6)
11.1
(0.3 to 48.2)
10.5
(1.3 to 33.1)
0
(0.0 to 33.6)
2.Secondary Outcome
Title Percentage of Participants Who Achieved an Objective Response
Hide Description Objective response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) within the first 6 cycles of treatment (or within 3 cycles for participants in the DIPG group). Disease assessments were based on MRI and assessed by an independent central review. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions compared to baseline, and/or the persistence of non-target lesions with no progression or decrease in size.
Time Frame 6 months (first 6 cycles) or 3 months (first 3 cycles) for participants in the DIPG group
Hide Outcome Measure Data
Hide Analysis Population Description
Response population
Arm/Group Title Diffuse Intrinsic Pontine Glioma Ependymoma High-grade Glioma Medulloblastoma
Hide Arm/Group Description:
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Overall Number of Participants Analyzed 9 9 19 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 33.6)
0
(0.0 to 33.6)
5.3
(0.1 to 26.0)
0
(0.0 to 33.6)
3.Secondary Outcome
Title Percentage of Participants With Long-term Stable Disease
Hide Description Long-term stable disease (SD) rate was defined as the percentage of participants who achieved SD maintained for ≥ 6 cycles (or > 3 cycles for DIPG), measured from the date of first dose of treatment. Disease assessments were based on MRI and assessed by an independent central review. SD: A decrease of < 50% or an increase of < 25% in the size of measurable lesions and no evidence of new lesions, response does not meet the criteria for CR, PR, or progressive disease, and/or the persistence of non-target lesions with no progression or decrease in size.
Time Frame 6 months (first 6 cycles) or 3 months (first 3 cycles) for participants in the DIPG group
Hide Outcome Measure Data
Hide Analysis Population Description
Response population
Arm/Group Title Diffuse Intrinsic Pontine Glioma Ependymoma High-grade Glioma Medulloblastoma
Hide Arm/Group Description:
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Overall Number of Participants Analyzed 9 9 19 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 33.6)
11.1
(0.3 to 48.2)
5.3
(0.1 to 26.0)
0
(0.0 to 33.6)
4.Secondary Outcome
Title Kaplan-Meier Estimate of Duration of Response
Hide Description Duration of response is defined as the time from the date of the first objective response (complete response or partial response) to disease progression, for participants with a response. Participants who did not have disease progression or had not died were censored at the time of their last disease assessment or at the time of start of new anticancer therapy, whichever occurred first. Progressive disease (PD): ≥ 25% increase in the size of the measurable lesions taking as a reference the smallest disease measurement recorded since the start of protocol therapy (nadir), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or if spine MRI and/or lumbar cerebrospinal fluid (CSF) cytology were previously negative and became positive.
Time Frame From the first dose of pomalidomide to the data cut-off date of 15 March 2019; median overall time on follow-up was 4.86 months (3.78, 5.65, 4.04, and 8.38 months in each group respectively).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the response population with an objective response
Arm/Group Title Diffuse Intrinsic Pontine Glioma Ependymoma High-grade Glioma Medulloblastoma
Hide Arm/Group Description:
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Overall Number of Participants Analyzed 0 0 1 0
Median (95% Confidence Interval)
Unit of Measure: weeks
NA [1] 
(NA to NA)
[1]
Could not be estimated due to the low number of participants with an event
5.Secondary Outcome
Title Kaplan-Meier Estimate of Progression-Free Survival (PFS)
Hide Description Progression-free survival was defined as the time from the date of first dose of pomalidomide until the date progressive disease (PD) was first observed or until the date of death due to any cause, whichever occurred first. Participants who did not have PD or had not died at the time of analysis were censored at the time of their last disease assessment or at the start of new anticancer therapy, whichever occurred first. Progressive Disease (PD): ≥ 25% increase in the size of the measurable lesions taking as a reference the smallest disease measurement recorded since the start of protocol therapy (nadir), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or if spine MRI and/or lumbar CSF cytology were previously negative and became positive.
Time Frame From the first dose of pomalidomide to the data cut-off date of 15 March 2019; median overall time on follow-up was 4.86 months (3.78, 5.65, 4.04, and 8.38 months in each group respectively).
Hide Outcome Measure Data
Hide Analysis Population Description
Response population
Arm/Group Title Diffuse Intrinsic Pontine Glioma Ependymoma High-grade Glioma Medulloblastoma
Hide Arm/Group Description:
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Overall Number of Participants Analyzed 9 9 19 9
Median (95% Confidence Interval)
Unit of Measure: weeks
11.29
(2.86 to 12.57)
8.43
(5.57 to 16.14)
7.86
(5.14 to 8.14)
8.43
(7.29 to 18.00)
6.Secondary Outcome
Title Kalan-Meier Estimate of Overall Survival
Hide Description Overall survival was defined as the time from the date of the first dose to the date of death (any cause). Participants who were alive were censored at the last known time that the participant was alive.
Time Frame From the first dose of pomalidomide to the data cut-off date of 15 March 2019; median overall time on follow-up was 4.86 months (3.78, 5.65, 4.04, and 8.38 months in each group respectively).
Hide Outcome Measure Data
Hide Analysis Population Description
Response population
Arm/Group Title Diffuse Intrinsic Pontine Glioma Ependymoma High-grade Glioma Medulloblastoma
Hide Arm/Group Description:
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Overall Number of Participants Analyzed 9 9 19 9
Median (95% Confidence Interval)
Unit of Measure: months
3.78 [1] 
(0.66 to NA)
12.02 [1] 
(2.86 to NA)
5.06
(2.04 to 11.63)
11.60 [1] 
(1.74 to NA)
[1]
Could not be estimated due to the low number of events
7.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description Treatment-emergent adverse events were defined as any adverse events (AE) occurring from the first dose of pomalidomide until 28 days after the last dose. The severity of each AE was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 and according to the following scale: Grade 1: Mild (transient or mild discomfort; no limitation in activity or medical intervention required); Grade 2: Moderate (mild to moderate limitation in activity, assistance may be needed; minimal medical intervention required); Grade 3: Severe (marked limitation in activity, assistance and medical intervention required, hospitalization possible); Grade 4: Life-threatening (extreme limitation in activity, significant assistance or medical intervention required, hospitalization or hospice care probable); Grade 5: Death. Drug-related AEs are those suspected by the Investigator as being related to administration of study drug.
Time Frame From first dose of pomalidomide until 28 days after the last dose; median treatment duration was 84 days in the DIPG group, 112.0 days in the ependymoma group, 40.5 days in the high-grade glioma group and 57.0 days in the medulloblastoma group.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received at least 1 dose of study drug.
Arm/Group Title Diffuse Intrinsic Pontine Glioma Ependymoma High-grade Glioma Medulloblastoma
Hide Arm/Group Description:
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
Overall Number of Participants Analyzed 11 9 22 10
Measure Type: Count of Participants
Unit of Measure: Participants
Any treatment-emergent adverse event (TEAE)
11
 100.0%
8
  88.9%
21
  95.5%
9
  90.0%
TEAE related to study drug
5
  45.5%
7
  77.8%
14
  63.6%
8
  80.0%
Serious TEAE
8
  72.7%
4
  44.4%
13
  59.1%
4
  40.0%
Serious TEAE related to study drug
1
   9.1%
0
   0.0%
6
  27.3%
0
   0.0%
Grade 3/4 TEAE
8
  72.7%
6
  66.7%
14
  63.6%
6
  60.0%
Grade 3/4 TEAE related to study drug
3
  27.3%
2
  22.2%
10
  45.5%
4
  40.0%
TEAE leading to death
5
  45.5%
1
  11.1%
3
  13.6%
1
  10.0%
TEAE leading to dose reduction
1
   9.1%
0
   0.0%
2
   9.1%
0
   0.0%
TEAE leading to dose interruption
4
  36.4%
3
  33.3%
5
  22.7%
2
  20.0%
TEAE leading to study drug discontinuation
2
  18.2%
1
  11.1%
2
   9.1%
0
   0.0%
Time Frame All-cause mortality is reported from enrollment to the data cut-off date of 15 March 2019; median overall time on follow-up was 4.86 months (3.78, 5.65, 4.04, and 8.38 months in each group respectively). Adverse events are reported from the first dose of study drug until 28 days after the last dose; median treatment duration was 84 days in the DIPG group, 112.0 days in the ependymoma group, 40.5 days in the high-grade glioma group and 57.0 days in the medulloblastoma group.
Adverse Event Reporting Description All-cause mortality is reported for all enrolled participants, regardless of whether the participant received study treatment or not. Adverse events are reported for all participants who received at least 1 dose of pomalidomide.
 
Arm/Group Title Diffuse Intrinsic Pontine Glioma Ependymoma High-grade Glioma Medulloblastoma
Hide Arm/Group Description Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first. Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first. Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first. Participants received 2.6 mg/m²/day oral pomalidomide on days 1 to 21 of each 28-day treatment cycle for up to 24 cycles or until disease progression, withdrawal of consent/assent, treatment became intolerable, or death, whichever occurred first.
All-Cause Mortality
Diffuse Intrinsic Pontine Glioma Ependymoma High-grade Glioma Medulloblastoma
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/11 (72.73%)   5/9 (55.56%)   13/23 (56.52%)   5/10 (50.00%) 
Hide Serious Adverse Events
Diffuse Intrinsic Pontine Glioma Ependymoma High-grade Glioma Medulloblastoma
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/11 (72.73%)   4/9 (44.44%)   13/22 (59.09%)   4/10 (40.00%) 
Blood and lymphatic system disorders         
Neutropenia  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Ear and labyrinth disorders         
Vertigo  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Eye disorders         
Vision blurred  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Constipation  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Nausea  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
General disorders         
Fatigue  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Gait disturbance  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
General physical health deterioration  1  2/11 (18.18%)  1/9 (11.11%)  2/22 (9.09%)  1/10 (10.00%) 
Malaise  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Pain  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Infections and infestations         
Anorectal infection  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Encephalitis  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Herpes zoster  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Mastoiditis  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Pneumonia  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Respiratory syncytial virus bronchitis  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Sepsis  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Metabolism and nutrition disorders         
Hyponatraemia  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  1/10 (10.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Tumour haemorrhage  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Nervous system disorders         
Ataxia  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Depressed level of consciousness  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Dizziness  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Dyskinesia  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Generalised tonic-clonic seizure  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Headache  1  1/11 (9.09%)  2/9 (22.22%)  1/22 (4.55%)  0/10 (0.00%) 
Hemiparesis  1  0/11 (0.00%)  0/9 (0.00%)  3/22 (13.64%)  0/10 (0.00%) 
Hydrocephalus  1  0/11 (0.00%)  2/9 (22.22%)  2/22 (9.09%)  0/10 (0.00%) 
Intracranial pressure increased  1  1/11 (9.09%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Monoplegia  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Neurological decompensation  1  1/11 (9.09%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Paraesthesia  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Presyncope  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Seizure  1  0/11 (0.00%)  0/9 (0.00%)  2/22 (9.09%)  1/10 (10.00%) 
Transient ischaemic attack  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Pneumonitis  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Respiratory failure  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
1
Term from vocabulary, 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diffuse Intrinsic Pontine Glioma Ependymoma High-grade Glioma Medulloblastoma
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/11 (100.00%)   8/9 (88.89%)   20/22 (90.91%)   9/10 (90.00%) 
Blood and lymphatic system disorders         
Anaemia  1  1/11 (9.09%)  3/9 (33.33%)  7/22 (31.82%)  2/10 (20.00%) 
Febrile neutropenia  1  0/11 (0.00%)  0/9 (0.00%)  2/22 (9.09%)  0/10 (0.00%) 
Leukopenia  1  3/11 (27.27%)  6/9 (66.67%)  8/22 (36.36%)  3/10 (30.00%) 
Lymphopenia  1  1/11 (9.09%)  6/9 (66.67%)  6/22 (27.27%)  0/10 (0.00%) 
Neutropenia  1  3/11 (27.27%)  7/9 (77.78%)  9/22 (40.91%)  4/10 (40.00%) 
Thrombocytopenia  1  0/11 (0.00%)  3/9 (33.33%)  8/22 (36.36%)  3/10 (30.00%) 
Cardiac disorders         
Bradycardia  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Sinus tachycardia  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Eye disorders         
Blindness  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Conjunctival hyperaemia  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Mydriasis  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  3/11 (27.27%)  1/9 (11.11%)  1/22 (4.55%)  1/10 (10.00%) 
Constipation  1  2/11 (18.18%)  1/9 (11.11%)  5/22 (22.73%)  3/10 (30.00%) 
Diarrhoea  1  0/11 (0.00%)  1/9 (11.11%)  5/22 (22.73%)  2/10 (20.00%) 
Dyspepsia  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Dysphagia  1  1/11 (9.09%)  0/9 (0.00%)  2/22 (9.09%)  0/10 (0.00%) 
Enteritis  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Nausea  1  2/11 (18.18%)  1/9 (11.11%)  4/22 (18.18%)  1/10 (10.00%) 
Odynophagia  1  1/11 (9.09%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Salivary hypersecretion  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  1/10 (10.00%) 
Stomatitis  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Vomiting  1  2/11 (18.18%)  4/9 (44.44%)  5/22 (22.73%)  4/10 (40.00%) 
General disorders         
Asthenia  1  0/11 (0.00%)  0/9 (0.00%)  3/22 (13.64%)  1/10 (10.00%) 
Fatigue  1  2/11 (18.18%)  1/9 (11.11%)  4/22 (18.18%)  2/10 (20.00%) 
Gait disturbance  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  1/10 (10.00%) 
General physical health deterioration  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Non-cardiac chest pain  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Oedema peripheral  1  0/11 (0.00%)  0/9 (0.00%)  2/22 (9.09%)  0/10 (0.00%) 
Pyrexia  1  2/11 (18.18%)  1/9 (11.11%)  2/22 (9.09%)  0/10 (0.00%) 
Hepatobiliary disorders         
Hyperbilirubinaemia  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Infections and infestations         
Bronchitis  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Device related infection  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Eye infection  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Fungal infection  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Laryngitis  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Molluscum contagiosum  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Nasopharyngitis  1  0/11 (0.00%)  0/9 (0.00%)  2/22 (9.09%)  1/10 (10.00%) 
Oral candidiasis  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Otitis externa  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Parotitis  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Pharyngitis  1  1/11 (9.09%)  1/9 (11.11%)  1/22 (4.55%)  0/10 (0.00%) 
Rhinitis  1  0/11 (0.00%)  3/9 (33.33%)  1/22 (4.55%)  0/10 (0.00%) 
Rhinovirus infection  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Upper respiratory tract infection  1  1/11 (9.09%)  1/9 (11.11%)  1/22 (4.55%)  2/10 (20.00%) 
Injury, poisoning and procedural complications         
Contusion  1  0/11 (0.00%)  0/9 (0.00%)  2/22 (9.09%)  0/10 (0.00%) 
Fall  1  0/11 (0.00%)  0/9 (0.00%)  2/22 (9.09%)  0/10 (0.00%) 
Ligament sprain  1  0/11 (0.00%)  0/9 (0.00%)  2/22 (9.09%)  0/10 (0.00%) 
Upper limb fracture  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Investigations         
Alanine aminotransferase increased  1  1/11 (9.09%)  1/9 (11.11%)  4/22 (18.18%)  2/10 (20.00%) 
Aspartate aminotransferase increased  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Blood alkaline phosphatase increased  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Gamma-glutamyltransferase increased  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Urine output decreased  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Weight decreased  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Weight increased  1  0/11 (0.00%)  0/9 (0.00%)  2/22 (9.09%)  0/10 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  2/11 (18.18%)  0/9 (0.00%)  3/22 (13.64%)  2/10 (20.00%) 
Hypercalcaemia  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Hyperglycaemia  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Hypernatraemia  1  0/11 (0.00%)  1/9 (11.11%)  1/22 (4.55%)  0/10 (0.00%) 
Hypoalbuminaemia  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  1/10 (10.00%) 
Hypocalcaemia  1  0/11 (0.00%)  1/9 (11.11%)  2/22 (9.09%)  1/10 (10.00%) 
Hypokalaemia  1  2/11 (18.18%)  1/9 (11.11%)  2/22 (9.09%)  2/10 (20.00%) 
Hypomagnesaemia  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Hyponatraemia  1  0/11 (0.00%)  0/9 (0.00%)  2/22 (9.09%)  1/10 (10.00%) 
Hypophosphataemia  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Muscle spasms  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  1/10 (10.00%) 
Muscular weakness  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Pain in extremity  1  1/11 (9.09%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Temporomandibular joint syndrome  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Haemangioma  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Nervous system disorders         
Aphasia  1  0/11 (0.00%)  1/9 (11.11%)  1/22 (4.55%)  0/10 (0.00%) 
Ataxia  1  2/11 (18.18%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Depressed level of consciousness  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Dizziness  1  0/11 (0.00%)  0/9 (0.00%)  3/22 (13.64%)  0/10 (0.00%) 
Headache  1  3/11 (27.27%)  4/9 (44.44%)  5/22 (22.73%)  3/10 (30.00%) 
Hemiparesis  1  0/11 (0.00%)  0/9 (0.00%)  2/22 (9.09%)  0/10 (0.00%) 
Hydrocephalus  1  0/11 (0.00%)  1/9 (11.11%)  1/22 (4.55%)  0/10 (0.00%) 
Muscle spasticity  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Paraesthesia  1  1/11 (9.09%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Peripheral sensory neuropathy  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  1/10 (10.00%) 
Pyramidal tract syndrome  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Seizure  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Somnolence  1  0/11 (0.00%)  0/9 (0.00%)  1/22 (4.55%)  1/10 (10.00%) 
Tremor  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
VIth nerve disorder  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Psychiatric disorders         
Anxiety  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  1/10 (10.00%) 
Confusional state  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  2/10 (20.00%) 
Insomnia  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Personality change  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Renal and urinary disorders         
Pollakiuria  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Urinary hesitation  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Urinary incontinence  1  0/11 (0.00%)  1/9 (11.11%)  1/22 (4.55%)  0/10 (0.00%) 
Urinary retention  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders         
Bronchostenosis  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Cough  1  1/11 (9.09%)  0/9 (0.00%)  3/22 (13.64%)  0/10 (0.00%) 
Dyspnoea  1  1/11 (9.09%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Hiccups  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Hypoxia  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Pharyngeal erythema  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Respiratory failure  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Rhinorrhoea  1  1/11 (9.09%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Sleep apnoea syndrome  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Tonsillar inflammation  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders         
Decubitus ulcer  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Dermatitis acneiform  1  1/11 (9.09%)  0/9 (0.00%)  2/22 (9.09%)  1/10 (10.00%) 
Dry skin  1  1/11 (9.09%)  2/9 (22.22%)  0/22 (0.00%)  0/10 (0.00%) 
Eczema  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
Pruritus  1  2/11 (18.18%)  3/9 (33.33%)  1/22 (4.55%)  1/10 (10.00%) 
Pruritus generalised  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Rash  1  2/11 (18.18%)  0/9 (0.00%)  1/22 (4.55%)  0/10 (0.00%) 
Rash maculo-papular  1  0/11 (0.00%)  3/9 (33.33%)  2/22 (9.09%)  2/10 (20.00%) 
Rash pruritic  1  0/11 (0.00%)  1/9 (11.11%)  0/22 (0.00%)  0/10 (0.00%) 
Urticaria  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Vascular disorders         
Flushing  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Hypertension  1  0/11 (0.00%)  0/9 (0.00%)  0/22 (0.00%)  1/10 (10.00%) 
Pallor  1  1/11 (9.09%)  0/9 (0.00%)  0/22 (0.00%)  0/10 (0.00%) 
1
Term from vocabulary, 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is > 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.
Results Point of Contact
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Name/Title: Anne McClain
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: clinicaltrialdisclosure@celgene.com
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03257631    
Other Study ID Numbers: CC-4047-BRN-001
U1111-1199-3348 ( Registry Identifier: WHO )
2016-002903-25 ( EudraCT Number )
First Submitted: August 18, 2017
First Posted: August 22, 2017
Results First Submitted: November 22, 2019
Results First Posted: December 10, 2019
Last Update Posted: February 11, 2020