Chemioterapia di combinazione con o senza trapianto autologo di cellule staminali nel trattamento di pazienti con linfoma a cellule B del sistema nervoso centrale
31 agosto 2026 aggiornato da: Alliance for Clinical Trials in Oncology
Uno studio randomizzato di fase II sulla chemioterapia di consolidamento mieloablativa rispetto a quella non mieloablativa per il linfoma primitivo a cellule B del sistema nervoso centrale di nuova diagnosi
The purpose of this study is to find out what effects (good and/or bad) treatment with chemotherapy and stem cell transplant compared with chemotherapy alone will have on primary CNS B-cell lymphoma. Currently the best treatment for patients with primary CNS B-cell lymphoma is not known.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Primary Objective:
To compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of HDT/ASCT versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and etoposide
Secondary Objectives:
- To compare the two-year event-free survival (EFS) of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine
- To compare the overall survival (OS) of patients treated with the consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine
- To assess the toxicities associated with consolidation HDT/ASCT versus consolidation consisting of etoposide and cytarabine
- To determine diffusion MRI metrics (ADCmini, ADC25%, and ADCmean) prior to induction chemotherapy, after one full induction chemotherapy cycle, and at the end of induction chemotherapy as a predictor of response and outcome (CALGB 581101)
- To determine brain FDG-PET metrics (tumor SUV and tumor versus background SUV) prior to induction chemotherapy, after one full induction chemotherapy cycle, and at the end of induction chemotherapy as a predictor of response and outcome (CALGB 581101)
- To determine whether low baseline ADC measurements are associated with shorter PFS and OS (CALGB 581101)
- To determine whether reduction in tumor SUV by > 25% on brain FDG-PET/CT after one cycle of induction therapy is associated with improved PFS and OS (CALGB 581101)
- To determine which IHC-based biomarkers are predictive of an adverse prognosis (CALGB 151113)
- To determine which IHC-based biomarkers are predictive of a favorable prognosis (CALGB 151113) for BCL6 (B-cell CLL/lymphoma 6), and STAT 6 (signal transducer and activator of transcription 6, interleukin-4 induced)
- To analyze tumor tissue for gene expression profiles, and to correlate these profiles with treatment outcomes (CALGB 151113)
- To determine whether CSF proteome is a predictor of outcomes (prognostic marker) irrespective of treatment arm (CALGB 151113) for (IL-10 (interleukin 10) and C3 (complement component 3)
- To assess the neurocognitive function of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy (etoposide and cytarabine) as measured by serial administration of the International PCNSL Collaborative Group (IPCG) neurocognitive battery and evaluate the long-term survivorship differences between the two arms (CALGB 71105)
Tipo di studio
Interventistico
Iscrizione (Effettivo)
113
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Alaska
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Anchorage, Alaska, Stati Uniti, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, Stati Uniti, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, Stati Uniti, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, Stati Uniti, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, Stati Uniti, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, Stati Uniti, 99508
- Katmai Oncology Group
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Anchorage, Alaska, Stati Uniti, 99508
- Providence Alaska Medical Center
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Anchorage, Alaska, Stati Uniti, 99504
- Anchorage Radiation Therapy Center
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California
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Burbank, California, Stati Uniti, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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La Jolla, California, Stati Uniti, 92093
- UC San Diego Moores Cancer Center
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Sacramento, California, Stati Uniti, 95817
- University of California Davis Comprehensive Cancer Center
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San Francisco, California, Stati Uniti, 94115
- UCSF Medical Center-Mount Zion
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San Francisco, California, Stati Uniti, 94143
- UCSF Medical Center-Parnassus
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06520
- Yale University
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Florida
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Tampa, Florida, Stati Uniti, 33612
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Emory University/Winship Cancer Institute
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Idaho
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Boise, Idaho, Stati Uniti, 83712
- Saint Luke's Mountain States Tumor Institute
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Fruitland, Idaho, Stati Uniti, 83619
- Saint Luke's Mountain States Tumor Institute - Fruitland
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Meridian, Idaho, Stati Uniti, 83642
- Saint Luke's Mountain States Tumor Institute - Meridian
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Nampa, Idaho, Stati Uniti, 83686
- Saint Luke's Mountain States Tumor Institute - Nampa
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Twin Falls, Idaho, Stati Uniti, 83301
- Saint Luke's Mountain States Tumor Institute-Twin Falls
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Illinois
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Chicago, Illinois, Stati Uniti, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, Stati Uniti, 60612
- University of Illinois
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Indiana
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Richmond, Indiana, Stati Uniti, 47374
- Reid Health
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160
- University of Kansas Cancer Center
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Kentucky
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Crestview Hills, Kentucky, Stati Uniti, 41017
- Oncology Hematology Care Inc-Crestview
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Louisiana
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New Orleans, Louisiana, Stati Uniti, 70112
- Tulane University Health Sciences Center
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Maryland
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Baltimore, Maryland, Stati Uniti, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Stati Uniti, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Stati Uniti, 02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Battle Creek, Michigan, Stati Uniti, 49017
- Bronson Battle Creek
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Grand Rapids, Michigan, Stati Uniti, 49503
- Spectrum Health at Butterworth Campus
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Grand Rapids, Michigan, Stati Uniti, 49503
- Mercy Health Saint Mary's
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Kalamazoo, Michigan, Stati Uniti, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Stati Uniti, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Stati Uniti, 49001
- Borgess Medical Center
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Muskegon, Michigan, Stati Uniti, 49444
- Mercy Health Mercy Campus
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Niles, Michigan, Stati Uniti, 49120
- Lakeland Community Hospital
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Reed City, Michigan, Stati Uniti, 49677
- Spectrum Health Reed City Hospital
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Saint Joseph, Michigan, Stati Uniti, 49085
- Marie Yeager Cancer Center
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Saint Joseph, Michigan, Stati Uniti, 49085
- Lakeland Hospital
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Traverse City, Michigan, Stati Uniti, 49684
- Munson Medical Center
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Wyoming, Michigan, Stati Uniti, 49519
- Metro Health Hospital
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic
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Missouri
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St Louis, Missouri, Stati Uniti, 63110
- Washington University School of Medicine
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68198
- University of Nebraska Medical Center
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New York
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New York, New York, Stati Uniti, 10065
- Weill Medical College of Cornell University
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Rochester, New York, Stati Uniti, 14642
- University of Rochester
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Stony Brook, New York, Stati Uniti, 11794
- Stony Brook University Medical Center
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Syracuse, New York, Stati Uniti, 13210
- State University of New York Upstate Medical University
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North Carolina
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Durham, North Carolina, Stati Uniti, 27710
- Duke University Medical Center
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Ohio
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Centerville, Ohio, Stati Uniti, 45459
- Dayton Physicians LLC-Miami Valley South
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Cincinnati, Ohio, Stati Uniti, 45242
- Oncology Hematology Care Inc-Blue Ash
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Cincinnati, Ohio, Stati Uniti, 45202
- Oncology Hematology Care Inc-Eden Park
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Cincinnati, Ohio, Stati Uniti, 45211
- Oncology Hematology Care Inc-Mercy West
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Cincinnati, Ohio, Stati Uniti, 45236
- Oncology Hematology Care Inc-Kenwood
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Cincinnati, Ohio, Stati Uniti, 45230
- Oncology Hematology Care Inc - Anderson
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Dayton, Ohio, Stati Uniti, 45406
- Good Samaritan Hospital - Dayton
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Dayton, Ohio, Stati Uniti, 45409
- Miami Valley Hospital
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Dayton, Ohio, Stati Uniti, 45415
- Dayton Physicians LLC-Samaritan North
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Dayton, Ohio, Stati Uniti, 45415
- Samaritan North Health Center
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Dayton, Ohio, Stati Uniti, 45420
- Dayton NCI Community Oncology Research Program
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Fairfield, Ohio, Stati Uniti, 45014
- Oncology Hematology Care Inc-Healthplex
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Findlay, Ohio, Stati Uniti, 45840
- Blanchard Valley Hospital
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Findlay, Ohio, Stati Uniti, 45840
- Armes Family Cancer Center
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Findlay, Ohio, Stati Uniti, 45840
- Orion Cancer Care
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Franklin, Ohio, Stati Uniti, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Franklin, Ohio, Stati Uniti, 45005
- Dayton Physicians LLC-Atrium
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Greenville, Ohio, Stati Uniti, 45331
- Wayne Hospital
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Greenville, Ohio, Stati Uniti, 45331
- Dayton Physicians LLC-Wayne
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Kettering, Ohio, Stati Uniti, 45429
- Kettering Medical Center
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Kettering, Ohio, Stati Uniti, 45409
- Greater Dayton Cancer Center
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Middletown, Ohio, Stati Uniti, 45042
- Dayton Physicians LLC-Signal Point
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Sidney, Ohio, Stati Uniti, 45365
- Dayton Physicians LLC-Wilson
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Springfield, Ohio, Stati Uniti, 45505
- Springfield Regional Medical Center
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Springfield, Ohio, Stati Uniti, 45504
- Springfield Regional Cancer Center
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Troy, Ohio, Stati Uniti, 45373
- Upper Valley Medical Center
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Troy, Ohio, Stati Uniti, 45373
- Dayton Physicians LLC-Upper Valley
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Oklahoma
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Tulsa, Oklahoma, Stati Uniti, 74136
- Surgical Associates Inc
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Tulsa, Oklahoma, Stati Uniti, 74146
- Warren Clinic Oncology-Tulsa
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Oregon
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Bend, Oregon, Stati Uniti, 97701
- Saint Charles Health System
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Clackamas, Oregon, Stati Uniti, 97015
- Clackamas Radiation Oncology Center
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Clackamas, Oregon, Stati Uniti, 97015
- Providence Oncology and Hematology Care Southeast
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Coos Bay, Oregon, Stati Uniti, 97420
- Bay Area Hospital
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Milwaukie, Oregon, Stati Uniti, 97222
- Providence Milwaukie Hospital
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Newberg, Oregon, Stati Uniti, 97132
- Providence Newberg Medical Center
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Oregon City, Oregon, Stati Uniti, 97045
- Providence Willamette Falls Medical Center
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Portland, Oregon, Stati Uniti, 97213
- Providence Portland Medical Center
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Portland, Oregon, Stati Uniti, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Danville, Pennsylvania, Stati Uniti, 17822
- Geisinger Medical Center
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Lewistown, Pennsylvania, Stati Uniti, 17044
- Lewistown Hospital
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Pittsburgh, Pennsylvania, Stati Uniti, 15232
- University of Pittsburgh Cancer Institute (UPCI)
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Utah
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Salt Lake City, Utah, Stati Uniti, 84112
- Huntsman Cancer Institute/University of Utah
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Vermont
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Berlin Corners, Vermont, Stati Uniti, 05602
- Central Vermont Medical Center/National Life Cancer Treatment
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Burlington, Vermont, Stati Uniti, 05401
- University of Vermont Medical Center
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Burlington, Vermont, Stati Uniti, 05405
- University of Vermont College of Medicine
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Virginia
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Richmond, Virginia, Stati Uniti, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Washington
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Aberdeen, Washington, Stati Uniti, 98520
- Providence Regional Cancer System-Aberdeen
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Anacortes, Washington, Stati Uniti, 98221
- Cancer Care Center at Island Hospital
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Bellevue, Washington, Stati Uniti, 98005
- Swedish Cancer Institute-Eastside Oncology Hematology
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Bellingham, Washington, Stati Uniti, 98225
- PeaceHealth Saint Joseph Medical Center
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Centralia, Washington, Stati Uniti, 98531
- Providence Regional Cancer System-Centralia
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Edmonds, Washington, Stati Uniti, 98026
- Swedish Medical Center-Edmonds
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Everett, Washington, Stati Uniti, 98201
- Providence Regional Cancer Partnership
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Issaquah, Washington, Stati Uniti, 98029
- Swedish Cancer Institute-Issaquah
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Lacey, Washington, Stati Uniti, 98503
- Providence Regional Cancer System-Lacey
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Longview, Washington, Stati Uniti, 98632
- PeaceHealth Saint John Medical Center
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Seattle, Washington, Stati Uniti, 98109
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, Stati Uniti, 98109
- Seattle Cancer Care Alliance
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Seattle, Washington, Stati Uniti, 98195
- University of Washington Medical Center
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Seattle, Washington, Stati Uniti, 98107
- Swedish Medical Center-Ballard Campus
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Seattle, Washington, Stati Uniti, 98104
- Minor and James Medical PLLC
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Seattle, Washington, Stati Uniti, 98104
- Pacific Gynecology Specialists
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Seattle, Washington, Stati Uniti, 98112
- Group Health Cooperative-Seattle
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Seattle, Washington, Stati Uniti, 98122-4307
- Swedish Medical Center-First Hill
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Shelton, Washington, Stati Uniti, 98584
- Providence Regional Cancer System-Shelton
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Spokane, Washington, Stati Uniti, 99204
- Rockwood Cancer Treatment Center-DHEC-Downtown
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Spokane Valley, Washington, Stati Uniti, 99216
- Rockwood Clinic Cancer Treatment Center-Valley
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Vancouver, Washington, Stati Uniti, 98664
- PeaceHealth Southwest Medical Center
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Vancouver, Washington, Stati Uniti, 98684
- Compass Oncology Vancouver
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Walla Walla, Washington, Stati Uniti, 99362
- Providence Saint Mary Regional Cancer Center
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Yakima, Washington, Stati Uniti, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
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Yelm, Washington, Stati Uniti, 98597
- Providence Regional Cancer System-Yelm
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Wisconsin
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La Crosse, Wisconsin, Stati Uniti, 54601
- Mayo Clinic Health System-Franciscan Healthcare
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Madison, Wisconsin, Stati Uniti, 53792
- University of Wisconsin Hospital and Clinics
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
- Documentation of Disease: Diagnosis of primary CNS diffuse large B-cell lymphoma confirmed by one of the following: brain biopsy or resection, cerebrospinal fluid and vitreous fluid.
- Other Lymphomas: Patients must have no evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS.
- Previous Treatment: Patients must have no prior chemotherapy or radiation therapy for lymphoma.
- Age- Patients must be between the ages of 18 and 75 years.
- Karnofsky Performance Scale - Patients must measure Karnofsky Performance Scale ≥ 30 (≥ 50 for patients ages 60-70).
- Pregnancy and Nursing Status - Patients must be non-pregnant and non-nursing; women of childbearing potential must have a negative serum or urine pregnancy test 10-14 days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom)
- HIV - Patients must have negative HIV serology.
- Hepatitis - Patients must have negative HCV serology (unless HBsAb positive patient has recently received HBV vaccine, in this case HBcAb should be negative). All patients must be screened for hepatitis B infection before starting treatment. Those patients who test positive for hepatitis B should be closely monitored for evidence of active HBV infection and hepatitis during and for several months after rituximab treatment. PCNSL patients with a history of hepatitis B infection should be treated with entecavir or lamivudine (physician discretion for choice of drug) as antiviral prophylaxis to prevent hepatitis B reactivation.
- Organ Transplant or Immunosuppressant Therapy - Patient must have no history of organ transplantation or ongoing immunosuppressant therapy.
- Required Initial Laboratory Values: ANC ≥ 1500/mcL, AST and ALT < 2 x upper limit of normal (ULN), total bilirubin ≤ 3 mg/dL, creatinine clearance ≥ 50 mL/min, platelet count ≥ 100,000/mcL
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: Arm I
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant. |
Given IV Given IV |
|
Altro: Arm II
Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy. |
Given IV Given IV |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression Free Survival
Lasso di tempo: 2 years
|
The primary endpoint is to compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of HDT/ASCT versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and etoposide. PFS time = time from Registration to earliest date of Progression or Death due to any cause, censoring non-progressed and alive patients at the date of last disease status evaluation. Response will be defined using the modified IPCG criteria. Progressive disease is defined as > 25% increase in contrast-enhancing CNS (brain and spine if latter abnormal at baseline) disease, appearance of any new, measurable (>/= 10mm) contrast-enhancing disease or recurrent or new ocular or CSF disease. |
2 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Event Free Survival
Lasso di tempo: 2 years
|
To compare the two-year event-free survival (EFS) of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine. EFS event = same definition as PFS with non-protocol treatment also considered an event |
2 years
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Lasso di tempo: 7 years
|
Number of patients reporting at least one adverse event at least possibly related to treatment. |
7 years
|
|
Overall Survival
Lasso di tempo: 2 years
|
To compare the overall survival (OS) of patients treated with the consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine. OS event = Registration/Randomization to Death due to any cause |
2 years
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Cattedra di studio: Tracy Batchelor, MD, MPH, Massachusetts General Hospital
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2012
Completamento primario (Effettivo)
14 gennaio 2021
Completamento dello studio (Effettivo)
24 febbraio 2022
Date di iscrizione allo studio
Primo inviato
13 gennaio 2012
Primo inviato che soddisfa i criteri di controllo qualità
13 gennaio 2012
Primo Inserito (Stimato)
18 gennaio 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- linfoma diffuso a grandi cellule dell'adulto in stadio III
- linfoma diffuso a grandi cellule dell'adulto in stadio IV
- linfoma non-Hodgkin primario del sistema nervoso centrale
- linfoma diffuso a grandi cellule dell'adulto di stadio II non contiguo
- linfoma diffuso a grandi cellule dell'adulto di stadio II contiguo
- stadio I adulto linfoma diffuso a grandi cellule
Termini MeSH pertinenti aggiuntivi
- Neoplasie
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie linfatiche
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Linfoma non Hodgkin
- Linfoma, cellule B
- Malattie emiche e linfatiche
- Linfoma
- Linfoma, a grandi cellule B, diffuso
- Peptidi
- Aminoacidi, peptidi e proteine
- Proteine
- Prodotti chimici organici
- Composti eterociclici, 1-anello
- Composti eterociclici
- Terapie
- Procedure chirurgiche, operative
- Acidi nucleici, nucleotidi e nucleosidi
- Idrocarburi
- Idrocarburi, ciclici
- Fattori biologici
- Carboidrati
- Podofillotossina
- Tetraidonaftalene
- Naftalene
- Idrocarburi policiclici aromatici
- Idrocarburi, aromatici
- Composti policiclici
- Glucosidi
- Glicosidi
- Trapianto
- Amides
- Citidina
- Nucleosidi di pirimidina
- Pirimidine
- Fosforamidi
- Composti organofosfori
- Nucleosidi
- Peptidi e proteine di segnalazione intercellulare
- Arabinonucleosidi
- Glicoproteine
- Glicoconiugati
- Trapianto di cellule
- Terapia a base di cellule e tessuti
- Terapia biologica
- Trietilenefosforamide
- Aziridine
- Azirines
- Fattori stimolanti le colonie
- Fattori di crescita delle cellule ematopoietiche
- Citochine
- Composti nitrosourea
- Urea
- Composti di nitroso
- Citarabina
- Carmustina
- Etoposide
- Tiotepa
- Trapianto di cellule staminali
- Fattore stimolante le colonie di granulociti
Altri numeri di identificazione dello studio
- CALGB-51101
- CDR0000721927 (Identificatore di registro: NCI Physician Data Query)
- NCI-2012-00110 (Identificatore di registro: NCI Clinical Trial Reporting Program)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .