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Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease

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ClinicalTrials.gov Identifier: NCT01309997
Recruitment Status : Completed
First Posted : March 7, 2011
Results First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lee, Stephanie, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Graft Versus Host Disease
Systemic Scleroderma
Interventions Drug: imatinib mesylate
Biological: rituximab
Enrollment 72

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Enzyme Inhibitor) Arm II (Monoclonal Antibody)
Hide Arm/Group Description Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab. Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.
Period Title: Overall Study
Started 35 37
Remained on First Arm Only 16 14
Crossed Over to Second Arm 19 23
Completed 30 31
Not Completed 5 6
Reason Not Completed
Adverse Event             1             0
Death             1             3
Lack of Efficacy             2             2
Withdrawal by Subject             1             1
Arm/Group Title Arm I (Enzyme Inhibitor) Arm II (Monoclonal Antibody) Total
Hide Arm/Group Description Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab. Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. TDuring the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib. Total of all reporting groups
Overall Number of Baseline Participants 35 37 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 37 participants 72 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
31
  88.6%
30
  81.1%
61
  84.7%
>=65 years
4
  11.4%
7
  18.9%
11
  15.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 37 participants 72 participants
Female
18
  51.4%
22
  59.5%
40
  55.6%
Male
17
  48.6%
15
  40.5%
32
  44.4%
1.Primary Outcome
Title Significant Clinical Response
Hide Description Assessed by decline in an affected area’s skin score as measured with the Vienna Skin Scale (from 4 [worst] to 2, 3 to 1, or 2 to 0 [best]) without a concurrent increase of two or more points in another area OR by an increase in the range of motion of the shoulders, elbows or wrists by two points (in a 1-7 scale where 1 is worst and 7 is best) or of the ankles by one point (in a 1 to 4 scale where 1 is worst and 4 is best) without a concurrent worsening in another area.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients were not eligible for evaluation if they discontinued participation or had missing 6 mo data.
Arm/Group Title Arm I (Enzyme Inhibitor) Arm II (Monoclonal Antibody)
Hide Arm/Group Description:
Patients who were randomized to receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity.
Patients who were randomized to receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle was repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity.
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: participants
9 10
2.Secondary Outcome
Title Patients Who Were Able to Taper Corticosteroids
Hide Description Patients who achieved a greater than or equal to 50% reduction in the daily corticosteroid dose at 6mo compared to baseline
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with no corticosteroid dose data missing from baseline or 6mo.
Arm/Group Title Arm I (Enzyme Inhibitor) Arm II (Monoclonal Antibody)
Hide Arm/Group Description:
Patients randomized to receive imatinib mesylate as their first therapy. They may take this from 1 mo-18 mo.
Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
Overall Number of Participants Analyzed 27 32
Measure Type: Number
Unit of Measure: participants
7 9
3.Secondary Outcome
Title Cumulative Incidence of Treatment Failure
Hide Description Defined as discontinuation of randomized treatment due to chronic GVHD progression or treatment intolerance or no significant clinical response in sclerosis.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients who were evaluable for SCR are included.
Arm/Group Title Arm I (Enzyme Inhibitor) Arm II (Monoclonal Antibody)
Hide Arm/Group Description:
Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: participants
24 26
4.Secondary Outcome
Title Number of Patients Achieving Improvement in Cutaneous Sclerosis
Hide Description Assessed by decrease of >= 0.2 units (where 0 is best and 3.0 is worst ) in the Scleroderma Health Assessment Questionnaire (SHAQ).
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients evaluable at 6 mo are included.
Arm/Group Title Arm 1 (Enzyme Inhibitor) Arm II (Monocolonal Antibody)
Hide Arm/Group Description:
Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: participants
2 9
5.Secondary Outcome
Title Baseline Histopathologic Score in the Two Treatment Arms
Hide Description

Instrument: Nash dermal fibrosis grade. Measures extent of sclerosis in skin biopsies by histologic examination. Scale ranges from grade 0-5. Nash grade 5 is most severe fibrosis (0 is better outcome, 5 is worse outcome). No subscales are used in Nash grade. Please see table 1 in the reference for grading of dermal fibrosis.

Nash RA, McSweeney PA, Crofford LJ, Abidi M, Chen CS, Godwin JD, et al. High-dose immunosuppressive therapy and autologous hematopoietic cell transplantation for severe systemic sclerosis: long-term follow-up of the US multicenter pilot study. Blood 2007;110:1388-96.

Time Frame Enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients with skin biopsies at enrollment are included.
Arm/Group Title Arm 1 (Enzyme Inhibitor) Arm II (Monoclonal Antibody)
Hide Arm/Group Description:
Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
Overall Number of Participants Analyzed 32 31
Median (Full Range)
Unit of Measure: units on a scale
2
(0 to 5)
2
(0 to 5)
6.Secondary Outcome
Title Patients With Any Percentage Decline in Any Grade of Sclerosis Without Increase in Percentage of Higher Grades of Sclerosis in Other Areas on the Vienna Skin Scale
Hide Description Maximum of 10 body areas. Each area can be graded 0 (best) to 4 (worst). Each of those grades requires a percentage of involvement. Improvement is measured by reduction of involvement in any grade and any body area.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients who were evaluable at 6mo are included.
Arm/Group Title Arm I (Enzyme Inhibitor) Arm II (Monoclonal Antibody)
Hide Arm/Group Description:
Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: participants
14 9
7.Secondary Outcome
Title Percentage of CD27+ B Cells in Responders (SCR) and Non-responders
Hide Description %CD27+ B cells
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab Responders Rituximab Non-responders Imatinib Responders Imatinib Nonresponders
Hide Arm/Group Description:
Attained a SCR with rituximab
Did not attain a SCR with rituximab
Attained a SCR with imatinib
Did not attain a SCR with imatinib
Overall Number of Participants Analyzed 3 10 3 11
Mean (Full Range)
Unit of Measure: percentage of CD27+ B cells
10
(5 to 17)
4.3
(0 to 9)
14.2
(5.2 to 21.6)
17.1
(4.8 to 23.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rituximab Responders, Rituximab Non-responders
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Imatinib Responders, Imatinib Nonresponders
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Imatinib as Initial Therapy Rituximab as Initial Therapy Imatinib as Secondary Therapy Rituximab as Secondary Therapy
Hide Arm/Group Description Arm I = imatinib, adverse event occurred after the start date of imatinib and if applicable, prior to start date of rituximab. Arm I = rituximab, adverse event occurred after the start date of rituximab and if applicable, prior to start date of imatinib. Arm II = imatinib, adverse event occurred after the start date of imatinib. (All participants in this group received rituximab prior). Arm II = rituximab, adverse event occurred after the start date of rituximab. (All participants in this group received imatinib prior).
All-Cause Mortality
Imatinib as Initial Therapy Rituximab as Initial Therapy Imatinib as Secondary Therapy Rituximab as Secondary Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Imatinib as Initial Therapy Rituximab as Initial Therapy Imatinib as Secondary Therapy Rituximab as Secondary Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/35 (31.43%)      19/37 (51.35%)      19/23 (82.61%)      15/19 (78.95%)    
Blood and lymphatic system disorders         
Febrile Neutropenia *  0/35 (0.00%)  0 1/37 (2.70%)  1 0/23 (0.00%)  0 1/19 (5.26%)  1
INR increased *  0/35 (0.00%)  0 0/37 (0.00%)  0 0/23 (0.00%)  0 1/19 (5.26%)  1
Neutropenia *  1/35 (2.86%)  1 2/37 (5.41%)  2 1/23 (4.35%)  1 2/19 (10.53%)  2
Cardiac disorders         
Aortic valve disease *  0/35 (0.00%)  0 1/37 (2.70%)  1 0/23 (0.00%)  0 0/19 (0.00%)  0
Other, specify: congestive heart failure *  0/35 (0.00%)  0 0/37 (0.00%)  0 0/23 (0.00%)  0 1/19 (5.26%)  1
Other, specify: coronary vasculopathy *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
Gastrointestinal disorders         
Diarrhea *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
Mucositis oral *  0/35 (0.00%)  0 1/37 (2.70%)  1 0/23 (0.00%)  0 0/19 (0.00%)  0
Vomiting *  0/35 (0.00%)  0 1/37 (2.70%)  1 0/23 (0.00%)  0 0/19 (0.00%)  0
General disorders         
Edema limbs *  1/35 (2.86%)  1 0/37 (0.00%)  0 0/23 (0.00%)  0 0/19 (0.00%)  0
Fatigue *  0/35 (0.00%)  0 1/37 (2.70%)  1 0/23 (0.00%)  0 0/19 (0.00%)  0
Fever *  0/35 (0.00%)  0 1/37 (2.70%)  1 1/23 (4.35%)  1 1/19 (5.26%)  1
Flu like symptoms *  0/35 (0.00%)  0 0/37 (0.00%)  0 0/23 (0.00%)  0 0/19 (0.00%)  0
Other, specify: Pneumoperitoneum *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
Infections and infestations         
Lung infection *  2/35 (5.71%)  2 2/37 (5.41%)  3 4/23 (17.39%)  4 1/19 (5.26%)  1
Other specify: Norovirus *  1/35 (2.86%)  1 0/37 (0.00%)  0 0/23 (0.00%)  0 0/19 (0.00%)  0
Other, specify: unknown etiology *  0/35 (0.00%)  0 0/37 (0.00%)  0 0/23 (0.00%)  0 1/19 (5.26%)  2
Sepsis *  0/35 (0.00%)  0 0/37 (0.00%)  0 2/23 (8.70%)  2 0/19 (0.00%)  0
Skin infection *  1/35 (2.86%)  1 0/37 (0.00%)  0 0/23 (0.00%)  0 0/19 (0.00%)  0
Urinary tract infection *  0/35 (0.00%)  0 1/37 (2.70%)  1 0/23 (0.00%)  0 0/19 (0.00%)  0
Injury, poisoning and procedural complications         
Fracture *  0/35 (0.00%)  0 1/37 (2.70%)  1 0/23 (0.00%)  0 0/19 (0.00%)  0
Metabolism and nutrition disorders         
Anorexia *  0/35 (0.00%)  0 1/37 (2.70%)  1 0/23 (0.00%)  0 0/19 (0.00%)  0
Dehydration *  0/35 (0.00%)  0 1/37 (2.70%)  1 1/23 (4.35%)  1 0/19 (0.00%)  0
Hyperglycemia *  1/35 (2.86%)  1 0/37 (0.00%)  0 0/23 (0.00%)  0 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Avascular necrosis *  0/35 (0.00%)  0 0/37 (0.00%)  0 0/23 (0.00%)  0 1/19 (5.26%)  1
Other, specify: mastectomy *  0/35 (0.00%)  0 0/37 (0.00%)  0 0/23 (0.00%)  0 1/19 (5.26%)  1
Pain in extremity *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Other, specify: brain tumor *  0/35 (0.00%)  0 1/37 (2.70%)  1 0/23 (0.00%)  0 0/19 (0.00%)  0
Renal and urinary disorders         
Acute kidney injury *  1/35 (2.86%)  1 0/37 (0.00%)  0 0/23 (0.00%)  0 1/19 (5.26%)  2
Respiratory, thoracic and mediastinal disorders         
Dyspnea *  0/35 (0.00%)  0 2/37 (5.41%)  2 2/23 (8.70%)  3 0/19 (0.00%)  0
Hypoxia *  0/35 (0.00%)  0 0/37 (0.00%)  0 0/23 (0.00%)  0 1/19 (5.26%)  1
Pneumonitis *  1/35 (2.86%)  1 1/37 (2.70%)  2 0/23 (0.00%)  0 1/19 (5.26%)  1
Pneumothorax *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
Respiratory failure *  2/35 (5.71%)  2 0/37 (0.00%)  0 3/23 (13.04%)  3 0/19 (0.00%)  0
Vascular disorders         
Hypotension *  0/35 (0.00%)  0 0/37 (0.00%)  0 0/23 (0.00%)  0 1/19 (5.26%)  1
Thromboembolic event *  0/35 (0.00%)  0 1/37 (2.70%)  1 0/23 (0.00%)  0 1/19 (5.26%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Imatinib as Initial Therapy Rituximab as Initial Therapy Imatinib as Secondary Therapy Rituximab as Secondary Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/35 (34.29%)      12/37 (32.43%)      21/23 (91.30%)      1/19 (5.26%)    
Blood and lymphatic system disorders         
Anemia *  1/35 (2.86%)  1 0/37 (0.00%)  0 1/23 (4.35%)  4 1/19 (5.26%)  1
Eye disorders         
Retinal detachment *  1/35 (2.86%)  1 0/37 (0.00%)  0 0/23 (0.00%)  0 0/19 (0.00%)  0
Gastrointestinal disorders         
Nausea *  1/35 (2.86%)  1 0/37 (0.00%)  0 0/23 (0.00%)  0 0/19 (0.00%)  0
General disorders         
Infusion related reaction *  0/35 (0.00%)  0 1/37 (2.70%)  1 0/23 (0.00%)  0 0/19 (0.00%)  0
Pain *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
Infections and infestations         
Lung infection *  1/35 (2.86%)  1 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
Skin infection *  0/35 (0.00%)  0 1/37 (2.70%)  1 0/23 (0.00%)  0 0/19 (0.00%)  0
Investigations         
Alanine aminotransferase increased *  1/35 (2.86%)  1 0/37 (0.00%)  0 0/23 (0.00%)  0 0/19 (0.00%)  0
Aspartate aminotransferase increased *  1/35 (2.86%)  1 0/37 (0.00%)  0 0/23 (0.00%)  0 0/19 (0.00%)  0
Creatinine increased *  1/35 (2.86%)  1 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
White blood cell decreased *  1/35 (2.86%)  1 1/37 (2.70%)  1 0/23 (0.00%)  0 0/19 (0.00%)  0
Forced expiratory volume decreased *  0/35 (0.00%)  0 1/37 (2.70%)  1 1/23 (4.35%)  1 0/19 (0.00%)  0
Lymphocyte count decreased *  0/35 (0.00%)  0 1/37 (2.70%)  2 1/23 (4.35%)  1 0/19 (0.00%)  0
Neutrophil count decreased *  0/35 (0.00%)  0 1/37 (2.70%)  1 1/23 (4.35%)  1 0/19 (0.00%)  0
Metabolism and nutrition disorders         
Anorexia *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
Hyperglycemia *  0/35 (0.00%)  0 3/37 (8.11%)  4 3/23 (13.04%)  3 0/19 (0.00%)  0
Hypophosphatemia *  2/35 (5.71%)  2 1/37 (2.70%)  2 1/23 (4.35%)  1 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Avascular necrosis *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  2 0/19 (0.00%)  0
Myalgia *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Treatment related secondary malignancy *  1/35 (2.86%)  1 0/37 (0.00%)  0 0/23 (0.00%)  0 0/19 (0.00%)  0
Other, specify: squamous cell carcinoma *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Unintended pregnancy *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
Psychiatric disorders         
Agitation *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
Renal and urinary disorders         
Renal calculi *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
Reproductive system and breast disorders         
Gynecomastia *  1/35 (2.86%)  1 0/37 (0.00%)  0 0/23 (0.00%)  0 0/19 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnea *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
Respiratory failure *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
Vascular disorders         
Hypertension *  0/35 (0.00%)  0 2/37 (5.41%)  3 0/23 (0.00%)  0 0/19 (0.00%)  0
Hypotension *  0/35 (0.00%)  0 0/37 (0.00%)  0 1/23 (4.35%)  1 0/19 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Stephanie J. Lee MD MPH
Organization: FHCRC
Phone: 206-667-6190
Responsible Party: Lee, Stephanie, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
ClinicalTrials.gov Identifier: NCT01309997     History of Changes
Other Study ID Numbers: 2343.00
NCI-2011-00098 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RDCRN 6502 ( Other Identifier: Rare Diseases Clinical Research Network II )
2343.00 ( Other Identifier: Fred Hutchinson Cancer Research Center )
U54CA163438 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: March 1, 2011
First Posted: March 7, 2011
Results First Submitted: September 21, 2015
Results First Posted: June 15, 2016
Last Update Posted: June 15, 2016