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Ofatumumab for Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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: NCT01113632
Recruitment Status : Completed
First Posted : April 30, 2010
Results First Posted : June 4, 2015
Last Update Posted : September 20, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Intervention Drug: Ofatumumab
Enrollment 77
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ofatumumab 1000mg Ofatumumab 2000mg
Hide Arm/Group Description

Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Period Title: Overall Study
Started 33 44
Completed 2 19
Not Completed 31 25
Arm/Group Title Ofatumumab 1000mg Ofatumumab 2000mg Total
Hide Arm/Group Description

Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Total of all reporting groups
Overall Number of Baseline Participants 33 44 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 33 participants 44 participants 77 participants
75
(50 to 93)
69
(47 to 88)
72
(47 to 93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 44 participants 77 participants
Female
17
  51.5%
19
  43.2%
36
  46.8%
Male
16
  48.5%
25
  56.8%
41
  53.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 44 participants 77 participants
33 44 77
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were evaluable for a response assessment
Arm/Group Title Ofatumumab 1000mg Ofatumumab 2000mg
Hide Arm/Group Description:

Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg.

Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Overall Number of Participants Analyzed 28 44
Measure Type: Number
Unit of Measure: participants
15 30
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description To assess the overall response rate of patients with previously untreated CLL or SLL receiving ofatumumab.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ofatumumab 1000mg Ofatumumab 2000mg
Hide Arm/Group Description:

Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg.

Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Overall Number of Participants Analyzed 33 44
Median (95% Confidence Interval)
Unit of Measure: months
19.8 [1] 
(9.7 to NA)
32.5 [1] 
(26.6 to NA)
[1]
Upper bound of the 95% confidence interval cannot be calculated as there is an insufficient number of events for this caluclation
3.Secondary Outcome
Title Number of Complete Responses
Hide Description The Number of Patients Who Experience a Complete Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions
Time Frame 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were evaluable for a response assessment
Arm/Group Title Ofatumumab 1000mg Ofatumumab 2000mg
Hide Arm/Group Description:

Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg.

Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Overall Number of Participants Analyzed 28 44
Measure Type: Number
Unit of Measure: participants
2 0
4.Secondary Outcome
Title Number of Partial Responses
Hide Description The Number of Patients Who Experience a Partial Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions
Time Frame 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were evaluable for a response assessment
Arm/Group Title Ofatumumab 1000mg Ofatumumab 2000mg
Hide Arm/Group Description:

Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg.

Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Overall Number of Participants Analyzed 28 44
Measure Type: Number
Unit of Measure: participants
13 30
5.Secondary Outcome
Title Safety of the Treatment Regimen
Hide Description Listing of all non-serious Adverse Events ocurring in 5% of patients or more
Time Frame 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ofatumumab 1000mg Ofatumumab 2000mg
Hide Arm/Group Description:

Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg.

Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Overall Number of Participants Analyzed 33 44
Measure Type: Number
Unit of Measure: participants
Fatigue 12 21
Allergic reaction 14 16
Anemia 14 13
Pain 9 14
Platelet count decreased 13 10
Rash 7 16
White blood cell decreased 10 9
Cough 5 13
Diarrhea 8 9
Neutrophil count decreased 7 10
Dyspnea 6 9
Hyperglycemia 4 11
Edema 8 6
Nausea 3 11
Infections and infestations - Other, unspecified 6 7
Peripheral sensory neuropathy 2 11
Constipation 2 10
Insomnia 3 9
Psychiatric disorders - Other, unspecified 5 7
Arthralgia 4 7
Dizziness 5 5
Hyperhidrosis 6 4
Hypocalcemia 4 5
Aspartate aminotransferase increased 6 2
Blood bilirubin increased 2 6
Oral pain 1 7
Respiratory, thoracic and mediastinal disorders 3 5
Non-cardiac chest pain 1 6
Pruritus 4 3
Abdominal pain 2 4
Allergic rhinitis 3 3
Anorexia 2 4
Back pain 2 4
Fever 2 4
Gastrointestinal disorders - Other, unknown 3 3
Headache 4 2
Hypertension 3 3
Hyponatremia 4 2
Dysgeusia 2 3
Flushing 1 4
Gastroesophageal reflux disease 3 2
Hypoglycemia 2 3
Musculoskeletal and connective tissue disorders 2 3
Skin and subcutaneous tissue disorders - Other 4 1
Upper respiratory infection 0 5
Vomiting 1 4
Alanine aminotransferase increased 2 2
Blurred vision 4 0
Bruising 1 3
Chills 1 3
Creatinine increased 1 3
Hypokalemia 1 3
Infusion related reaction 1 3
Urinary frequency 1 3
Weight loss 2 2
Time Frame 18 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ofatumumab 1000mg Ofatumumab 2000mg
Hide Arm/Group Description

Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks

Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.

All-Cause Mortality
Ofatumumab 1000mg Ofatumumab 2000mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Ofatumumab 1000mg Ofatumumab 2000mg
Affected / at Risk (%) Affected / at Risk (%)
Total   3/33 (9.09%)   2/44 (4.55%) 
Blood and lymphatic system disorders     
Anemia  1  1/33 (3.03%)  0/44 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal disorders - Other, hernia  1  1/33 (3.03%)  0/44 (0.00%) 
Gastrointestinal disorders - Other, unknown  1  1/33 (3.03%)  0/44 (0.00%) 
Vomiting  1  1/33 (3.03%)  0/44 (0.00%) 
General disorders     
Edema  1  1/33 (3.03%)  0/44 (0.00%) 
Fever  1  1/33 (3.03%)  0/44 (0.00%) 
Investigations     
Cholesterol high  1  1/33 (3.03%)  0/44 (0.00%) 
Creatinine increased  1  0/33 (0.00%)  1/44 (2.27%) 
Metabolism and nutrition disorders     
Hypoalbuminemia  1  1/33 (3.03%)  0/44 (0.00%) 
Nervous system disorders     
Dysgeusia  1  1/33 (3.03%)  0/44 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  1/33 (3.03%)  0/44 (0.00%) 
Pneumonitis  1  0/33 (0.00%)  1/44 (2.27%) 
Skin and subcutaneous tissue disorders     
Urticaria  1  1/33 (3.03%)  0/44 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ofatumumab 1000mg Ofatumumab 2000mg
Affected / at Risk (%) Affected / at Risk (%)
Total   32/33 (96.97%)   42/44 (95.45%) 
Blood and lymphatic system disorders     
Anemia  1  14/33 (42.42%)  13/44 (29.55%) 
Eye disorders     
Blurred vision  1  4/33 (12.12%)  0/44 (0.00%) 
Gastrointestinal disorders     
Diarrhea  1  8/33 (24.24%)  9/44 (20.45%) 
Nausea  1  3/33 (9.09%)  11/44 (25.00%) 
Constipation  1  2/33 (6.06%)  10/44 (22.73%) 
Oral pain  1  1/33 (3.03%)  7/44 (15.91%) 
Abdominal pain  1  2/33 (6.06%)  4/44 (9.09%) 
Gastrointestinal disorders - Other, unknown  1  3/33 (9.09%)  3/44 (6.82%) 
Gastroesophageal reflux disease  1  3/33 (9.09%)  2/44 (4.55%) 
Vomiting  1  1/33 (3.03%)  4/44 (9.09%) 
General disorders     
Fatigue  1  12/33 (36.36%)  21/44 (47.73%) 
Pain  1  9/33 (27.27%)  14/44 (31.82%) 
Edema  1  8/33 (24.24%)  6/44 (13.64%) 
Non-cardiac chest pain  1  1/33 (3.03%)  6/44 (13.64%) 
Fever  1  2/33 (6.06%)  4/44 (9.09%) 
Chills  1  1/33 (3.03%)  3/44 (6.82%) 
Infusion related reaction  1  1/33 (3.03%)  3/44 (6.82%) 
Immune system disorders     
Allergic reaction  1  14/33 (42.42%)  16/44 (36.36%) 
Infections and infestations     
Infections and infestations - Other, unspecified  1  6/33 (18.18%)  7/44 (15.91%) 
Upper respiratory infection  1  0/33 (0.00%)  5/44 (11.36%) 
Injury, poisoning and procedural complications     
Bruising  1  1/33 (3.03%)  3/44 (6.82%) 
Investigations     
Platelet count decreased  1  13/33 (39.39%)  10/44 (22.73%) 
White blood cell decreased  1  10/33 (30.30%)  9/44 (20.45%) 
Neutrophil count decreased  1  7/33 (21.21%)  10/44 (22.73%) 
Aspartate aminotransferase increased  1  6/33 (18.18%)  2/44 (4.55%) 
Blood bilirubin increased  1  2/33 (6.06%)  6/44 (13.64%) 
Alanine aminotransferase increased  1  2/33 (6.06%)  2/44 (4.55%) 
Creatinine increased  1  1/33 (3.03%)  3/44 (6.82%) 
Weight loss  1  2/33 (6.06%)  2/44 (4.55%) 
Metabolism and nutrition disorders     
Hyperglycemia  1  4/33 (12.12%)  11/44 (25.00%) 
Hypocalcemia  1  4/33 (12.12%)  5/44 (11.36%) 
Anorexia  1  2/33 (6.06%)  4/44 (9.09%) 
Hyponatremia  1  4/33 (12.12%)  2/44 (4.55%) 
Hypoglycemia  1  2/33 (6.06%)  3/44 (6.82%) 
Hypokalemia  1  1/33 (3.03%)  3/44 (6.82%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/33 (12.12%)  7/44 (15.91%) 
Back pain  1  2/33 (6.06%)  4/44 (9.09%) 
Musculoskeletal and connective tissue disorders - Other, unknown  1  2/33 (6.06%)  3/44 (6.82%) 
Nervous system disorders     
Peripheral sensory neuropathy  1  2/33 (6.06%)  11/44 (25.00%) 
Dizziness  1  5/33 (15.15%)  5/44 (11.36%) 
Headache  1  4/33 (12.12%)  2/44 (4.55%) 
Dysgeusia  1  2/33 (6.06%)  3/44 (6.82%) 
Psychiatric disorders     
Insomnia  1  3/33 (9.09%)  9/44 (20.45%) 
Psychiatric disorders - Other, mood alteration  1  5/33 (15.15%)  7/44 (15.91%) 
Renal and urinary disorders     
Urinary frequency  1  1/33 (3.03%)  3/44 (6.82%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/33 (15.15%)  13/44 (29.55%) 
Dyspnea  1  6/33 (18.18%)  9/44 (20.45%) 
Respiratory, thoracic and mediastinal disorders - Other, unknown  1  3/33 (9.09%)  5/44 (11.36%) 
Allergic rhinitis  1  3/33 (9.09%)  3/44 (6.82%) 
Skin and subcutaneous tissue disorders     
Rash  1  7/33 (21.21%)  16/44 (36.36%) 
Hyperhidrosis  1  6/33 (18.18%)  4/44 (9.09%) 
Pruritus  1  4/33 (12.12%)  3/44 (6.82%) 
Skin and subcutaneous tissue disorders - Other  1  4/33 (12.12%)  1/44 (2.27%) 
Vascular disorders     
Hypertension  1  3/33 (9.09%)  3/44 (6.82%) 
Flushing  1  1/33 (3.03%)  4/44 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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 sponsor can review/embargo results communications prior to public release for a period that is >60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John D Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 1-877-691-7274
EMail: asksarah@scresearch.net
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01113632    
Other Study ID Numbers: SCRI CLL 11
First Submitted: April 28, 2010
First Posted: April 30, 2010
Results First Submitted: May 18, 2015
Results First Posted: June 4, 2015
Last Update Posted: September 20, 2016