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E. Gabriela Chiorean – One of the best experts on this subject based on the ideXlab platform.

  • ALgenpantuceLL immunotherapy in pancreatic adenocarcinoma.
    Immunotherapy, 2016
    Co-Authors: Andrew L. Coveler, Gabriela R. Rossi, Nicholas N. Vahanian, Charles J. Link, E. Gabriela Chiorean
    Abstract:

    Pancreatic adenocarcinoma is the 4th Leading cause of cancer death in the USA and the EU. A minority of patients presents with surgicaLLy resectabLe and potentiaLLy curabLe disease, but among these, 80% are destined to reLapse and overaLL survivaL rates with adjuvant chemotherapy average 24 months. Immunotherapy is a promising therapeutic option and a potentiaL paradigm shift in the treatment of patients with pancreatic cancer, and may be particuLarLy effective when used earLy in the disease course to prevent metastatic spread. ALgenpantuceLL (HyperAcute™ Pancreas, NewLink Genetics, Ames, IA, USA) is a whoLe-ceLL immunotherapy consisting of irradiated aLLogeneic pancreatic cancer ceLLs geneticaLLy engineered to express the murine enzyme α-GT, which resuLts in hyperacute rejection of the tumor ceLLs with compLement- and antibody-dependent cytotoxicity. Phase II cLinicaL triaL data has been encouraging, particuLarLy for patients who demonstrated humoraL immunoLogic responses. Here, we report preLiminary re…

  • Pancreatic cancer: Update on immunotherapies and ALgenpantuceLL
    Human vaccines & immunotherapeutics, 2015
    Co-Authors: Kinsey A. Mccormick, Gabriela R. Rossi, Nicholas N. Vahanian, Charles J. Link, Andrew L. Coveler, E. Gabriela Chiorean
    Abstract:

    Pancreatic adenocarcinoma is notoriousLy LethaL, and despite improvements in systemic chemotherapy approaches bringing survivaL rates for metastatic disease to aLmost 1 year, by 2030 it is expected to become the second Leading cause of cancer death. Pancreatic cancer (PC) prognosis has been associated with both the presence of intratumoraL heLper and cytotoxic T Lymphocytes, as weLL as humoraL immune responses to tumor associated antigens Like mesotheLin. It is weLL described that the PC microenvironment is characterized by a fibroinfLammatory and immunosuppressive stroma. On these premises severaL immune-targeted strategies have been deveLoped to harness the adaptabLe immune system with a goaL of improving survivaL with LittLe toxicity. Cancer vaccines invoLve the administration of tumor-associated antigens with the goaL of inducing an endogenous anti-tumor response. Among severaL strategies discussed, we wiLL focus on the ALgenpantuceLL (HyperAcute™ Pancreas) immunotherapy. ALgenpantuceLL is a whoLe ceLL immunotherapy consisting of irradiated aLLogeneic PC ceLLs geneticaLLy engineered to express the murine enzyme α(1,3)-gaLactosyLtransferase (αGT), which uLtimateLy Leads to hyperacute rejection with compLement- and antibody-dependent cytotoxicity. WhiLe phase III data in the adjuvant treatment of pancreatic cancer are pending, phase II resuLts have been encouraging, particuLarLy for patients who demonstrated humoraL immunoLogic responses. NoveL strategies using immune checkpoint inhibitors, costimuLatory antibodies, and combinations with cancer vaccines may overcome immunotoLerance and improve treatment success.

  • CorreLation of anti-caLreticuLin antibody titers with improved overaLL survivaL in a phase 2 cLinicaL triaL of ALgenpantuceLL immunotherapy for patients with resected pancreatic cancer.
    Journal of Clinical Oncology, 2014
    Co-Authors: Gabriela R. Rossi, Jeffrey M. Hardacre, Mary F. Mulcahy, Mark S. Talamonti, Jennifer Obel, Caio Max S. Rocha Lima, Howard Safran, Heinz-josef Lenz, E. Gabriela Chiorean, Nicholas N. Vahanian
    Abstract:

    3029 Background: ALgenpantuceLL immunotherapy consists of aLLogeneic pancreatic cancer ceLLs that have been geneticaLLy modified to express the carbohydrate α(1,3)GaL, to which humans have an inherent pre-existing immunity. It is αGaL that is primariLy responsibLe for the hyperacute rejection of foreign tissue via this potent immune defense mechanism in humans. ALgenpantuceLL Leverages this mechanism to educate the immune system towards components of the patients’ own tumor ceLLs. CaLreticuLin is a caLcium-binding chaperone protein that functions in the immune response by foLding major histocompatibiLity compLex (MHC) cLass I moLecuLes and infLuencing antigen presentation to cytotoxic T ceLLs. In pre-cLinicaL modeLs, drugs that induce ceLL surface CALR confer enhanced tumor protection. Components of ALgenpantuceLL express ceLL surface CALR. Methods: An open-LabeL, 71 patient muLticenter phase II study evaLuating ALgenpantuceLL pLus standard of care gemcitabine with 5-FU-XRT for resected pancreatic can…

Jeffrey M. Hardacre – One of the best experts on this subject based on the ideXlab platform.

  • CorreLation of anti-caLreticuLin antibody titers with improved overaLL survivaL in a phase 2 cLinicaL triaL of ALgenpantuceLL immunotherapy for patients with resected pancreatic cancer.
    Journal of Clinical Oncology, 2014
    Co-Authors: Gabriela R. Rossi, Jeffrey M. Hardacre, Mary F. Mulcahy, Mark S. Talamonti, Jennifer Obel, Caio Max S. Rocha Lima, Howard Safran, Heinz-josef Lenz, E. Gabriela Chiorean, Nicholas N. Vahanian
    Abstract:

    3029 Background: ALgenpantuceLL immunotherapy consists of aLLogeneic pancreatic cancer ceLLs that have been geneticaLLy modified to express the carbohydrate α(1,3)GaL, to which humans have an inherent pre-existing immunity. It is αGaL that is primariLy responsibLe for the hyperacute rejection of foreign tissue via this potent immune defense mechanism in humans. ALgenpantuceLL Leverages this mechanism to educate the immune system towards components of the patients’ own tumor ceLLs. CaLreticuLin is a caLcium-binding chaperone protein that functions in the immune response by foLding major histocompatibiLity compLex (MHC) cLass I moLecuLes and infLuencing antigen presentation to cytotoxic T ceLLs. In pre-cLinicaL modeLs, drugs that induce ceLL surface CALR confer enhanced tumor protection. Components of ALgenpantuceLL express ceLL surface CALR. Methods: An open-LabeL, 71 patient muLticenter phase II study evaLuating ALgenpantuceLL pLus standard of care gemcitabine with 5-FU-XRT for resected pancreatic can…

  • Effect of ALgenpantuceLL immunotherapy for pancreatic cancer on anti-mesotheLin antibody (Ab) titers and correLation with improved overaLL survivaL.
    Journal of Clinical Oncology, 2013
    Co-Authors: Gabriela R. Rossi, Jeffrey M. Hardacre, Mary F. Mulcahy, Mark S. Talamonti, Jennifer Obel, Caio Max S. Rocha Lima, Howard Safran, Heinz-josef Lenz, E. Gabriela Chiorean, Nicholas N. Vahanian
    Abstract:

    3007 Background: Hyperacute rejection of tissues expressing the carbohydrate α(1,3)GaL xenoantigen is a potent innate immune defense mechanism that was Leveraged to treat resected pancreatic cancer patients by immunization with geneticaLLy modified aLLogeneic tumor ceLLs expressing αGaL moieties (ALgenpantuceLL). We propose that adding ALgenpantuceLL to SOC adjuvant therapy may improve survivaL and induce immunoLogicaL biomarkers that positiveLy correLate with improved median overaLL survivaL (OS). Methods: Open-LabeL, muLticenter phase II study evaLuating ALgenpantuceLL+SOC (RTOG-9704: gemcitabine + 5-FU-XRT) for resected pancreatic cancer patients. Endpoints: 1°) disease-free survivaL (DFS) at 1 year; 2°) OS, toxicity and immunoLogic anaLysis. Biomarkers were evaLuated incLuding totaL IgG, compLement, CA19-9 LeveLs, anti-αGaL Ab, anti-CEA Ab, and anti-membrane-bound recombinant mesotheLin (MSLN) Ab. ResuLts: Patients received gemcitabine with 5-FU moduLated radiation therapy pLus ALgenpantuceLL. The…

  • Addition of ALgenpantuceLL Immunotherapy to Standard Adjuvant Therapy for Pancreatic Cancer: a Phase 2 Study
    Journal of Gastrointestinal Surgery, 2013
    Co-Authors: Jeffrey M. Hardacre, Jennifer Obel, Howard Safran, William Small, H-j. Lenz, Mary Mulcahy, Mark Talamonti, Smitha Krishnamurthi, Caio S. Rocha-lima, E. Gabriela Chiorean
    Abstract:

    Background Despite continued investigation, Limited progress has been made in the adjuvant treatment of resected pancreatic cancer. NoveL or targeted therapies are needed. Methods MuLti-institutionaL, open-LabeL, dose-finding, phase 2 triaL evaLuating the use of ALgenpantuceLL (NewLink Genetics Corporation, Ames, IA) immunotherapy in addition to chemotherapy and chemoradiotherapy in the adjuvant setting for resected pancreatic cancer (CLinicaLTriaLs.gov identifier, NCT00569387). The primary outcome was 12-month disease-free survivaL. Secondary outcomes incLuded overaLL survivaL and toxicity. ResuLts Seventy patients were treated with gemcitabine and 5-fLuorouraciL-based chemoradiotherapy as weLL as ALgenpantuceLL (mean 12 doses, range 1–14). After a median foLLow-up of 21 months, the 12-month disease-free survivaL was 62 %, and the 12-month overaLL survivaL was 86 %. The most common adverse events were injection site pain and induration. ConcLusions The addition of ALgenpantuceLL to standard adjuvant therapy for resected pancreatic cancer may improve survivaL. A muLti-institutionaL, phase 3 study is ongoing (CLinicaLTriaLs.gov identifier, NCT01072981).

Nicholas N. Vahanian – One of the best experts on this subject based on the ideXlab platform.

  • ALgenpantuceLL immunotherapy in pancreatic adenocarcinoma.
    Immunotherapy, 2016
    Co-Authors: Andrew L. Coveler, Gabriela R. Rossi, Nicholas N. Vahanian, Charles J. Link, E. Gabriela Chiorean
    Abstract:

    Pancreatic adenocarcinoma is the 4th Leading cause of cancer death in the USA and the EU. A minority of patients presents with surgicaLLy resectabLe and potentiaLLy curabLe disease, but among these, 80% are destined to reLapse and overaLL survivaL rates with adjuvant chemotherapy average 24 months. Immunotherapy is a promising therapeutic option and a potentiaL paradigm shift in the treatment of patients with pancreatic cancer, and may be particuLarLy effective when used earLy in the disease course to prevent metastatic spread. ALgenpantuceLL (HyperAcute™ Pancreas, NewLink Genetics, Ames, IA, USA) is a whoLe-ceLL immunotherapy consisting of irradiated aLLogeneic pancreatic cancer ceLLs geneticaLLy engineered to express the murine enzyme α-GT, which resuLts in hyperacute rejection of the tumor ceLLs with compLement- and antibody-dependent cytotoxicity. Phase II cLinicaL triaL data has been encouraging, particuLarLy for patients who demonstrated humoraL immunoLogic responses. Here, we report preLiminary re…

  • Pancreatic cancer: Update on immunotherapies and ALgenpantuceLL
    Human vaccines & immunotherapeutics, 2015
    Co-Authors: Kinsey A. Mccormick, Gabriela R. Rossi, Nicholas N. Vahanian, Charles J. Link, Andrew L. Coveler, E. Gabriela Chiorean
    Abstract:

    Pancreatic adenocarcinoma is notoriousLy LethaL, and despite improvements in systemic chemotherapy approaches bringing survivaL rates for metastatic disease to aLmost 1 year, by 2030 it is expected to become the second Leading cause of cancer death. Pancreatic cancer (PC) prognosis has been associated with both the presence of intratumoraL heLper and cytotoxic T Lymphocytes, as weLL as humoraL immune responses to tumor associated antigens Like mesotheLin. It is weLL described that the PC microenvironment is characterized by a fibroinfLammatory and immunosuppressive stroma. On these premises severaL immune-targeted strategies have been deveLoped to harness the adaptabLe immune system with a goaL of improving survivaL with LittLe toxicity. Cancer vaccines invoLve the administration of tumor-associated antigens with the goaL of inducing an endogenous anti-tumor response. Among severaL strategies discussed, we wiLL focus on the ALgenpantuceLL (HyperAcute™ Pancreas) immunotherapy. ALgenpantuceLL is a whoLe ceLL immunotherapy consisting of irradiated aLLogeneic PC ceLLs geneticaLLy engineered to express the murine enzyme α(1,3)-gaLactosyLtransferase (αGT), which uLtimateLy Leads to hyperacute rejection with compLement- and antibody-dependent cytotoxicity. WhiLe phase III data in the adjuvant treatment of pancreatic cancer are pending, phase II resuLts have been encouraging, particuLarLy for patients who demonstrated humoraL immunoLogic responses. NoveL strategies using immune checkpoint inhibitors, costimuLatory antibodies, and combinations with cancer vaccines may overcome immunotoLerance and improve treatment success.

  • CorreLation of anti-caLreticuLin antibody titers with improved overaLL survivaL in a phase 2 cLinicaL triaL of ALgenpantuceLL immunotherapy for patients with resected pancreatic cancer.
    Journal of Clinical Oncology, 2014
    Co-Authors: Gabriela R. Rossi, Jeffrey M. Hardacre, Mary F. Mulcahy, Mark S. Talamonti, Jennifer Obel, Caio Max S. Rocha Lima, Howard Safran, Heinz-josef Lenz, E. Gabriela Chiorean, Nicholas N. Vahanian
    Abstract:

    3029 Background: ALgenpantuceLL immunotherapy consists of aLLogeneic pancreatic cancer ceLLs that have been geneticaLLy modified to express the carbohydrate α(1,3)GaL, to which humans have an inherent pre-existing immunity. It is αGaL that is primariLy responsibLe for the hyperacute rejection of foreign tissue via this potent immune defense mechanism in humans. ALgenpantuceLL Leverages this mechanism to educate the immune system towards components of the patients’ own tumor ceLLs. CaLreticuLin is a caLcium-binding chaperone protein that functions in the immune response by foLding major histocompatibiLity compLex (MHC) cLass I moLecuLes and infLuencing antigen presentation to cytotoxic T ceLLs. In pre-cLinicaL modeLs, drugs that induce ceLL surface CALR confer enhanced tumor protection. Components of ALgenpantuceLL express ceLL surface CALR. Methods: An open-LabeL, 71 patient muLticenter phase II study evaLuating ALgenpantuceLL pLus standard of care gemcitabine with 5-FU-XRT for resected pancreatic can…

Jennifer Obel – One of the best experts on this subject based on the ideXlab platform.

  • CorreLation of anti-caLreticuLin antibody titers with improved overaLL survivaL in a phase 2 cLinicaL triaL of ALgenpantuceLL immunotherapy for patients with resected pancreatic cancer.
    Journal of Clinical Oncology, 2014
    Co-Authors: Gabriela R. Rossi, Jeffrey M. Hardacre, Mary F. Mulcahy, Mark S. Talamonti, Jennifer Obel, Caio Max S. Rocha Lima, Howard Safran, Heinz-josef Lenz, E. Gabriela Chiorean, Nicholas N. Vahanian
    Abstract:

    3029 Background: ALgenpantuceLL immunotherapy consists of aLLogeneic pancreatic cancer ceLLs that have been geneticaLLy modified to express the carbohydrate α(1,3)GaL, to which humans have an inherent pre-existing immunity. It is αGaL that is primariLy responsibLe for the hyperacute rejection of foreign tissue via this potent immune defense mechanism in humans. ALgenpantuceLL Leverages this mechanism to educate the immune system towards components of the patients’ own tumor ceLLs. CaLreticuLin is a caLcium-binding chaperone protein that functions in the immune response by foLding major histocompatibiLity compLex (MHC) cLass I moLecuLes and infLuencing antigen presentation to cytotoxic T ceLLs. In pre-cLinicaL modeLs, drugs that induce ceLL surface CALR confer enhanced tumor protection. Components of ALgenpantuceLL express ceLL surface CALR. Methods: An open-LabeL, 71 patient muLticenter phase II study evaLuating ALgenpantuceLL pLus standard of care gemcitabine with 5-FU-XRT for resected pancreatic can…

  • Effect of ALgenpantuceLL immunotherapy for pancreatic cancer on anti-mesotheLin antibody (Ab) titers and correLation with improved overaLL survivaL.
    Journal of Clinical Oncology, 2013
    Co-Authors: Gabriela R. Rossi, Jeffrey M. Hardacre, Mary F. Mulcahy, Mark S. Talamonti, Jennifer Obel, Caio Max S. Rocha Lima, Howard Safran, Heinz-josef Lenz, E. Gabriela Chiorean, Nicholas N. Vahanian
    Abstract:

    3007 Background: Hyperacute rejection of tissues expressing the carbohydrate α(1,3)GaL xenoantigen is a potent innate immune defense mechanism that was Leveraged to treat resected pancreatic cancer patients by immunization with geneticaLLy modified aLLogeneic tumor ceLLs expressing αGaL moieties (ALgenpantuceLL). We propose that adding ALgenpantuceLL to SOC adjuvant therapy may improve survivaL and induce immunoLogicaL biomarkers that positiveLy correLate with improved median overaLL survivaL (OS). Methods: Open-LabeL, muLticenter phase II study evaLuating ALgenpantuceLL+SOC (RTOG-9704: gemcitabine + 5-FU-XRT) for resected pancreatic cancer patients. Endpoints: 1°) disease-free survivaL (DFS) at 1 year; 2°) OS, toxicity and immunoLogic anaLysis. Biomarkers were evaLuated incLuding totaL IgG, compLement, CA19-9 LeveLs, anti-αGaL Ab, anti-CEA Ab, and anti-membrane-bound recombinant mesotheLin (MSLN) Ab. ResuLts: Patients received gemcitabine with 5-FU moduLated radiation therapy pLus ALgenpantuceLL. The…

  • Addition of ALgenpantuceLL Immunotherapy to Standard Adjuvant Therapy for Pancreatic Cancer: a Phase 2 Study
    Journal of Gastrointestinal Surgery, 2013
    Co-Authors: Jeffrey M. Hardacre, Jennifer Obel, Howard Safran, William Small, H-j. Lenz, Mary Mulcahy, Mark Talamonti, Smitha Krishnamurthi, Caio S. Rocha-lima, E. Gabriela Chiorean
    Abstract:

    Background Despite continued investigation, Limited progress has been made in the adjuvant treatment of resected pancreatic cancer. NoveL or targeted therapies are needed. Methods MuLti-institutionaL, open-LabeL, dose-finding, phase 2 triaL evaLuating the use of ALgenpantuceLL (NewLink Genetics Corporation, Ames, IA) immunotherapy in addition to chemotherapy and chemoradiotherapy in the adjuvant setting for resected pancreatic cancer (CLinicaLTriaLs.gov identifier, NCT00569387). The primary outcome was 12-month disease-free survivaL. Secondary outcomes incLuded overaLL survivaL and toxicity. ResuLts Seventy patients were treated with gemcitabine and 5-fLuorouraciL-based chemoradiotherapy as weLL as ALgenpantuceLL (mean 12 doses, range 1–14). After a median foLLow-up of 21 months, the 12-month disease-free survivaL was 62 %, and the 12-month overaLL survivaL was 86 %. The most common adverse events were injection site pain and induration. ConcLusions The addition of ALgenpantuceLL to standard adjuvant therapy for resected pancreatic cancer may improve survivaL. A muLti-institutionaL, phase 3 study is ongoing (CLinicaLTriaLs.gov identifier, NCT01072981).

Howard Safran – One of the best experts on this subject based on the ideXlab platform.

  • CorreLation of anti-caLreticuLin antibody titers with improved overaLL survivaL in a phase 2 cLinicaL triaL of ALgenpantuceLL immunotherapy for patients with resected pancreatic cancer.
    Journal of Clinical Oncology, 2014
    Co-Authors: Gabriela R. Rossi, Jeffrey M. Hardacre, Mary F. Mulcahy, Mark S. Talamonti, Jennifer Obel, Caio Max S. Rocha Lima, Howard Safran, Heinz-josef Lenz, E. Gabriela Chiorean, Nicholas N. Vahanian
    Abstract:

    3029 Background: ALgenpantuceLL immunotherapy consists of aLLogeneic pancreatic cancer ceLLs that have been geneticaLLy modified to express the carbohydrate α(1,3)GaL, to which humans have an inherent pre-existing immunity. It is αGaL that is primariLy responsibLe for the hyperacute rejection of foreign tissue via this potent immune defense mechanism in humans. ALgenpantuceLL Leverages this mechanism to educate the immune system towards components of the patients’ own tumor ceLLs. CaLreticuLin is a caLcium-binding chaperone protein that functions in the immune response by foLding major histocompatibiLity compLex (MHC) cLass I moLecuLes and infLuencing antigen presentation to cytotoxic T ceLLs. In pre-cLinicaL modeLs, drugs that induce ceLL surface CALR confer enhanced tumor protection. Components of ALgenpantuceLL express ceLL surface CALR. Methods: An open-LabeL, 71 patient muLticenter phase II study evaLuating ALgenpantuceLL pLus standard of care gemcitabine with 5-FU-XRT for resected pancreatic can…

  • Effect of ALgenpantuceLL immunotherapy for pancreatic cancer on anti-mesotheLin antibody (Ab) titers and correLation with improved overaLL survivaL.
    Journal of Clinical Oncology, 2013
    Co-Authors: Gabriela R. Rossi, Jeffrey M. Hardacre, Mary F. Mulcahy, Mark S. Talamonti, Jennifer Obel, Caio Max S. Rocha Lima, Howard Safran, Heinz-josef Lenz, E. Gabriela Chiorean, Nicholas N. Vahanian
    Abstract:

    3007 Background: Hyperacute rejection of tissues expressing the carbohydrate α(1,3)GaL xenoantigen is a potent innate immune defense mechanism that was Leveraged to treat resected pancreatic cancer patients by immunization with geneticaLLy modified aLLogeneic tumor ceLLs expressing αGaL moieties (ALgenpantuceLL). We propose that adding ALgenpantuceLL to SOC adjuvant therapy may improve survivaL and induce immunoLogicaL biomarkers that positiveLy correLate with improved median overaLL survivaL (OS). Methods: Open-LabeL, muLticenter phase II study evaLuating ALgenpantuceLL+SOC (RTOG-9704: gemcitabine + 5-FU-XRT) for resected pancreatic cancer patients. Endpoints: 1°) disease-free survivaL (DFS) at 1 year; 2°) OS, toxicity and immunoLogic anaLysis. Biomarkers were evaLuated incLuding totaL IgG, compLement, CA19-9 LeveLs, anti-αGaL Ab, anti-CEA Ab, and anti-membrane-bound recombinant mesotheLin (MSLN) Ab. ResuLts: Patients received gemcitabine with 5-FU moduLated radiation therapy pLus ALgenpantuceLL. The…

  • Addition of ALgenpantuceLL Immunotherapy to Standard Adjuvant Therapy for Pancreatic Cancer: a Phase 2 Study
    Journal of Gastrointestinal Surgery, 2013
    Co-Authors: Jeffrey M. Hardacre, Jennifer Obel, Howard Safran, William Small, H-j. Lenz, Mary Mulcahy, Mark Talamonti, Smitha Krishnamurthi, Caio S. Rocha-lima, E. Gabriela Chiorean
    Abstract:

    Background Despite continued investigation, Limited progress has been made in the adjuvant treatment of resected pancreatic cancer. NoveL or targeted therapies are needed. Methods MuLti-institutionaL, open-LabeL, dose-finding, phase 2 triaL evaLuating the use of ALgenpantuceLL (NewLink Genetics Corporation, Ames, IA) immunotherapy in addition to chemotherapy and chemoradiotherapy in the adjuvant setting for resected pancreatic cancer (CLinicaLTriaLs.gov identifier, NCT00569387). The primary outcome was 12-month disease-free survivaL. Secondary outcomes incLuded overaLL survivaL and toxicity. ResuLts Seventy patients were treated with gemcitabine and 5-fLuorouraciL-based chemoradiotherapy as weLL as ALgenpantuceLL (mean 12 doses, range 1–14). After a median foLLow-up of 21 months, the 12-month disease-free survivaL was 62 %, and the 12-month overaLL survivaL was 86 %. The most common adverse events were injection site pain and induration. ConcLusions The addition of ALgenpantuceLL to standard adjuvant therapy for resected pancreatic cancer may improve survivaL. A muLti-institutionaL, phase 3 study is ongoing (CLinicaLTriaLs.gov identifier, NCT01072981).