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出境医 / 临床实验 / Ruxolitinib in Myelofibrosis Patients in Lombardy, Italy

Ruxolitinib in Myelofibrosis Patients in Lombardy, Italy

Study Description
Brief Summary:
The RUXOREL-MF observational study includes patients with primary and post-essential thrombocythemia/post-polycythemia vera myelofibrosis (MF) being treated with the oral JAK1-/JAK2-inhibitor ruxolitinib in a "real world" setting. Patients are treated according to current indications in Italy (i.e., primary and secondary MF patients with intermediate-1, intermediate-2, and high risk IPSS (International Prognostic Scoring System) scores and symptomatic splenomegaly and/or systemic symptoms). Patients are treated at facilities pertaining to the regional Hematology Network of Lombardy (Rete Ematologica Lombarda) in Italy. Efficacy data, data related to infectious and vascular events, data related to second primary malignancies, data regarding disease progression/transformation, and molecular information in relationship to ruxolitinib treatment will be collected and analyzed.

Condition or disease Intervention/treatment
Myelofibrosis Drug: Ruxolitinib

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 620 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Observational, Retrospective and Prospective Study on the Use of Ruxolitinib in Myelofibrosis Patients in Lombardy, Italy
Actual Study Start Date : April 11, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Rate of infectious events after ruxolitinib exposure in myelofibrosis patients [ Time Frame: Through study completion, an average of 1 year ]
  2. Rate of vascular events after ruxolitinib exposure in myelofibrosis patients [ Time Frame: Through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Spleen response rate [ Time Frame: At 3 and 6 months from ruxolitinib start ]
  2. Rate of primary secondary malignancies [ Time Frame: Through study completion, an average of 1 year ]
  3. Acute myeloid leukemia transformation rate [ Time Frame: Through study completion, an average of 1 year ]
  4. Rate of infectious events according to driver mutational status (i.e., mutations of JAK2, CALR, or MPL) [ Time Frame: Through study completion, an average of 1 year ]
    Association of rate of infectious events with driver mutational status

  5. Rate of vascular events according to driver mutational status (i.e., mutations of JAK2, CALR, or MPL) [ Time Frame: Through study completion, an average of 1 year ]
    Association of rate of vascular events with driver mutational status

  6. Spleen response rate according to driver mutational status (i.e., mutations of JAK2, CALR, or MPL) [ Time Frame: Through study completion, an average of 1 year ]
    Association of spleen response rate with driver mutational status

  7. Rate of primary secondary malignancies according to driver mutational status (i.e., mutations of JAK2, CALR, or MPL) [ Time Frame: Through study completion, an average of 1 year ]
    Association of rate of primary secondary malignancies with driver mutational status

  8. Acute myeloid leukemia transformation rate according to driver mutational status (i.e., mutations of JAK2, CALR, or MPL) [ Time Frame: Through study completion, an average of 1 year ]
    Association of acute myeloid leukemia transformation rate with driver mutational status

  9. Rate of infectious events according to the presence of additional mutations [ Time Frame: Through study completion, an average of 1 year ]
    Association of rate of infectious events with the presence of additional mutations

  10. Rate of vascular events according to the presence of additional mutations [ Time Frame: Through study completion, an average of 1 year ]
    Association of rate of vascular events with the presence of additional mutations

  11. Spleen response rate according to the presence of additional mutations [ Time Frame: Through study completion, an average of 1 year ]
    Association of spleen response rate with the presence of additional mutations

  12. Rate of primary secondary malignancies according to the presence of additional mutations [ Time Frame: Through study completion, an average of 1 year ]
    Association of rate of primary secondary malignancies with the presence of additional mutations

  13. Acute myeloid leukemia transformation rate according to the presence of additional mutations [ Time Frame: Through study completion, an average of 1 year ]
    Association of acute myeloid leukemia transformation rate with the presence of additional mutations

  14. Evaluation of overall survival after ruxolitinib start and, if applicable, discontinuation [ Time Frame: Through study completion, an average of 1 year ]

Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date April 7, 2019
First Posted Date May 22, 2019
Last Update Posted Date May 22, 2019
Actual Study Start Date April 11, 2017
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 18, 2019)
  • Rate of infectious events after ruxolitinib exposure in myelofibrosis patients [ Time Frame: Through study completion, an average of 1 year ]
  • Rate of vascular events after ruxolitinib exposure in myelofibrosis patients [ Time Frame: Through study completion, an average of 1 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 18, 2019)
  • Spleen response rate [ Time Frame: At 3 and 6 months from ruxolitinib start ]
  • Rate of primary secondary malignancies [ Time Frame: Through study completion, an average of 1 year ]
  • Acute myeloid leukemia transformation rate [ Time Frame: Through study completion, an average of 1 year ]
  • Rate of infectious events according to driver mutational status (i.e., mutations of JAK2, CALR, or MPL) [ Time Frame: Through study completion, an average of 1 year ]
    Association of rate of infectious events with driver mutational status
  • Rate of vascular events according to driver mutational status (i.e., mutations of JAK2, CALR, or MPL) [ Time Frame: Through study completion, an average of 1 year ]
    Association of rate of vascular events with driver mutational status
  • Spleen response rate according to driver mutational status (i.e., mutations of JAK2, CALR, or MPL) [ Time Frame: Through study completion, an average of 1 year ]
    Association of spleen response rate with driver mutational status
  • Rate of primary secondary malignancies according to driver mutational status (i.e., mutations of JAK2, CALR, or MPL) [ Time Frame: Through study completion, an average of 1 year ]
    Association of rate of primary secondary malignancies with driver mutational status
  • Acute myeloid leukemia transformation rate according to driver mutational status (i.e., mutations of JAK2, CALR, or MPL) [ Time Frame: Through study completion, an average of 1 year ]
    Association of acute myeloid leukemia transformation rate with driver mutational status
  • Rate of infectious events according to the presence of additional mutations [ Time Frame: Through study completion, an average of 1 year ]
    Association of rate of infectious events with the presence of additional mutations
  • Rate of vascular events according to the presence of additional mutations [ Time Frame: Through study completion, an average of 1 year ]
    Association of rate of vascular events with the presence of additional mutations
  • Spleen response rate according to the presence of additional mutations [ Time Frame: Through study completion, an average of 1 year ]
    Association of spleen response rate with the presence of additional mutations
  • Rate of primary secondary malignancies according to the presence of additional mutations [ Time Frame: Through study completion, an average of 1 year ]
    Association of rate of primary secondary malignancies with the presence of additional mutations
  • Acute myeloid leukemia transformation rate according to the presence of additional mutations [ Time Frame: Through study completion, an average of 1 year ]
    Association of acute myeloid leukemia transformation rate with the presence of additional mutations
  • Evaluation of overall survival after ruxolitinib start and, if applicable, discontinuation [ Time Frame: Through study completion, an average of 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ruxolitinib in Myelofibrosis Patients in Lombardy, Italy
Official Title Observational, Retrospective and Prospective Study on the Use of Ruxolitinib in Myelofibrosis Patients in Lombardy, Italy
Brief Summary The RUXOREL-MF observational study includes patients with primary and post-essential thrombocythemia/post-polycythemia vera myelofibrosis (MF) being treated with the oral JAK1-/JAK2-inhibitor ruxolitinib in a "real world" setting. Patients are treated according to current indications in Italy (i.e., primary and secondary MF patients with intermediate-1, intermediate-2, and high risk IPSS (International Prognostic Scoring System) scores and symptomatic splenomegaly and/or systemic symptoms). Patients are treated at facilities pertaining to the regional Hematology Network of Lombardy (Rete Ematologica Lombarda) in Italy. Efficacy data, data related to infectious and vascular events, data related to second primary malignancies, data regarding disease progression/transformation, and molecular information in relationship to ruxolitinib treatment will be collected and analyzed.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with primary myelofibrosis diagnosis according to the WHO (World Health Organization) 2016 classification or post-essential thrombocythemia/post-polycythemia vera myelofibrosis diagnosis according to the IWG-MRT (International Working Group for Myelofibrosis Research and Treatment) 2008 classification, with an intermediate-1, intermediate-2, or high risk score according to the IPSS (International Prognostic Scoring System), treated with ruxolitinib in accordance with current indications in Italy and pertaining to centers of the regional Hematology Network of Lombardy (Rete Ematologica Lombarda), Italy.
Condition Myelofibrosis
Intervention Drug: Ruxolitinib
Observational study including patients with myelofibrosis being treated with ruxolitinib in a "real world" setting. Patients are treated according to current indications.
Study Groups/Cohorts Not Provided
Publications *
  • Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, Bloomfield CD, Cazzola M, Vardiman JW. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544. Epub 2016 Apr 11. Review.
  • Barosi G, Mesa RA, Thiele J, Cervantes F, Campbell PJ, Verstovsek S, Dupriez B, Levine RL, Passamonti F, Gotlib J, Reilly JT, Vannucchi AM, Hanson CA, Solberg LA, Orazi A, Tefferi A; International Working Group for Myelofibrosis Research and Treatment (IWG-MRT). Proposed criteria for the diagnosis of post-polycythemia vera and post-essential thrombocythemia myelofibrosis: a consensus statement from the International Working Group for Myelofibrosis Research and Treatment. Leukemia. 2008 Feb;22(2):437-8. Epub 2007 Aug 30.
  • Caramazza D, Begna KH, Gangat N, Vaidya R, Siragusa S, Van Dyke DL, Hanson C, Pardanani A, Tefferi A. Refined cytogenetic-risk categorization for overall and leukemia-free survival in primary myelofibrosis: a single center study of 433 patients. Leukemia. 2011 Jan;25(1):82-8. doi: 10.1038/leu.2010.234. Epub 2010 Oct 14.
  • Cervantes F, Dupriez B, Pereira A, Passamonti F, Reilly JT, Morra E, Vannucchi AM, Mesa RA, Demory JL, Barosi G, Rumi E, Tefferi A. New prognostic scoring system for primary myelofibrosis based on a study of the International Working Group for Myelofibrosis Research and Treatment. Blood. 2009 Mar 26;113(13):2895-901. doi: 10.1182/blood-2008-07-170449. Epub 2008 Nov 6.
  • Cervantes F, Vannucchi AM, Kiladjian JJ, Al-Ali HK, Sirulnik A, Stalbovskaya V, McQuitty M, Hunter DS, Levy RS, Passamonti F, Barbui T, Barosi G, Harrison CN, Knoops L, Gisslinger H; COMFORT-II investigators. Three-year efficacy, safety, and survival findings from COMFORT-II, a phase 3 study comparing ruxolitinib with best available therapy for myelofibrosis. Blood. 2013 Dec 12;122(25):4047-53. doi: 10.1182/blood-2013-02-485888. Epub 2013 Oct 30. Erratum in: Blood. 2016 Dec 22;128(25):3013.
  • Gangat N, Caramazza D, Vaidya R, George G, Begna K, Schwager S, Van Dyke D, Hanson C, Wu W, Pardanani A, Cervantes F, Passamonti F, Tefferi A. DIPSS plus: a refined Dynamic International Prognostic Scoring System for primary myelofibrosis that incorporates prognostic information from karyotype, platelet count, and transfusion status. J Clin Oncol. 2011 Feb 1;29(4):392-7. doi: 10.1200/JCO.2010.32.2446. Epub 2010 Dec 13.
  • Guglielmelli P, Biamonte F, Rotunno G, Artusi V, Artuso L, Bernardis I, Tenedini E, Pieri L, Paoli C, Mannarelli C, Fjerza R, Rumi E, Stalbovskaya V, Squires M, Cazzola M, Manfredini R, Harrison C, Tagliafico E, Vannucchi AM; COMFORT-II Investigators; Associazione Italiana per la Ricerca sul Cancro Gruppo Italiano Malattie Mieloproliferative (AGIMM) Investigators. Impact of mutational status on outcomes in myelofibrosis patients treated with ruxolitinib in the COMFORT-II study. Blood. 2014 Apr 3;123(14):2157-60. doi: 10.1182/blood-2013-11-536557. Epub 2014 Jan 23.
  • Guglielmelli P, Lasho TL, Rotunno G, Mudireddy M, Mannarelli C, Nicolosi M, Pacilli A, Pardanani A, Rumi E, Rosti V, Hanson CA, Mannelli F, Ketterling RP, Gangat N, Rambaldi A, Passamonti F, Barosi G, Barbui T, Cazzola M, Vannucchi AM, Tefferi A. MIPSS70: Mutation-Enhanced International Prognostic Score System for Transplantation-Age Patients With Primary Myelofibrosis. J Clin Oncol. 2018 Feb 1;36(4):310-318. doi: 10.1200/JCO.2017.76.4886. Epub 2017 Dec 9.
  • Harrison C, Kiladjian JJ, Al-Ali HK, Gisslinger H, Waltzman R, Stalbovskaya V, McQuitty M, Hunter DS, Levy R, Knoops L, Cervantes F, Vannucchi AM, Barbui T, Barosi G. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):787-98. doi: 10.1056/NEJMoa1110556.
  • Harrison CN, Vannucchi AM, Kiladjian JJ, Al-Ali HK, Gisslinger H, Knoops L, Cervantes F, Jones MM, Sun K, McQuitty M, Stalbovskaya V, Gopalakrishna P, Barbui T. Long-term findings from COMFORT-II, a phase 3 study of ruxolitinib vs best available therapy for myelofibrosis. Leukemia. 2016 Aug;30(8):1701-7. doi: 10.1038/leu.2016.148. Epub 2016 May 23. Erratum in: Leukemia. 2017 Mar;31(3):775.
  • Heine A, Brossart P, Wolf D. Ruxolitinib is a potent immunosuppressive compound: is it time for anti-infective prophylaxis? Blood. 2013 Nov 28;122(23):3843-4. doi: 10.1182/blood-2013-10-531103.
  • Kröger NM, Deeg JH, Olavarria E, Niederwieser D, Bacigalupo A, Barbui T, Rambaldi A, Mesa R, Tefferi A, Griesshammer M, Gupta V, Harrison C, Alchalby H, Vannucchi AM, Cervantes F, Robin M, Ditschkowski M, Fauble V, McLornan D, Ballen K, Popat UR, Passamonti F, Rondelli D, Barosi G. Indication and management of allogeneic stem cell transplantation in primary myelofibrosis: a consensus process by an EBMT/ELN international working group. Leukemia. 2015 Nov;29(11):2126-33. doi: 10.1038/leu.2015.233. Epub 2015 Aug 21. Review.
  • Newberry KJ, Patel K, Masarova L, Luthra R, Manshouri T, Jabbour E, Bose P, Daver N, Cortes J, Kantarjian H, Verstovsek S. Clonal evolution and outcomes in myelofibrosis after ruxolitinib discontinuation. Blood. 2017 Aug 31;130(9):1125-1131. doi: 10.1182/blood-2017-05-783225. Epub 2017 Jul 3.
  • Passamonti F, Maffioli M. Update from the latest WHO classification of MPNs: a user's manual. Hematology Am Soc Hematol Educ Program. 2016 Dec 2;2016(1):534-542. Review.
  • Passamonti F, Cervantes F, Vannucchi AM, Morra E, Rumi E, Pereira A, Guglielmelli P, Pungolino E, Caramella M, Maffioli M, Pascutto C, Lazzarino M, Cazzola M, Tefferi A. A dynamic prognostic model to predict survival in primary myelofibrosis: a study by the IWG-MRT (International Working Group for Myeloproliferative Neoplasms Research and Treatment). Blood. 2010 Mar 4;115(9):1703-8. doi: 10.1182/blood-2009-09-245837. Epub 2009 Dec 14.
  • Passamonti F, Mora B, Giorgino T, Guglielmelli P, Cazzola M, Maffioli M, Rambaldi A, Caramella M, Komrokji R, Gotlib J, Kiladjian JJ, Cervantes F, Devos T, Palandri F, De Stefano V, Ruggeri M, Silver R, Benevolo G, Albano F, Caramazza D, Rumi E, Merli M, Pietra D, Casalone R, Barbui T, Pieri L, Vannucchi AM. Driver mutations' effect in secondary myelofibrosis: an international multicenter study based on 781 patients. Leukemia. 2017 Apr;31(4):970-973. doi: 10.1038/leu.2016.351. Epub 2016 Nov 25.
  • Passamonti F, Giorgino T, Mora B, Guglielmelli P, Rumi E, Maffioli M, Rambaldi A, Caramella M, Komrokji R, Gotlib J, Kiladjian JJ, Cervantes F, Devos T, Palandri F, De Stefano V, Ruggeri M, Silver RT, Benevolo G, Albano F, Caramazza D, Merli M, Pietra D, Casalone R, Rotunno G, Barbui T, Cazzola M, Vannucchi AM. A clinical-molecular prognostic model to predict survival in patients with post polycythemia vera and post essential thrombocythemia myelofibrosis. Leukemia. 2017 Dec;31(12):2726-2731. doi: 10.1038/leu.2017.169. Epub 2017 May 31.
  • Rotunno G, Pacilli A, Artusi V, Rumi E, Maffioli M, Delaini F, Brogi G, Fanelli T, Pancrazzi A, Pietra D, Bernardis I, Belotti C, Pieri L, Sant'Antonio E, Salmoiraghi S, Cilloni D, Rambaldi A, Passamonti F, Barbui T, Manfredini R, Cazzola M, Tagliafico E, Vannucchi AM, Guglielmelli P. Epidemiology and clinical relevance of mutations in postpolycythemia vera and postessential thrombocythemia myelofibrosis: A study on 359 patients of the AGIMM group. Am J Hematol. 2016 Jul;91(7):681-6. doi: 10.1002/ajh.24377. Epub 2016 May 11.
  • Rumi E, Pietra D, Pascutto C, Guglielmelli P, Martínez-Trillos A, Casetti I, Colomer D, Pieri L, Pratcorona M, Rotunno G, Sant'Antonio E, Bellini M, Cavalloni C, Mannarelli C, Milanesi C, Boveri E, Ferretti V, Astori C, Rosti V, Cervantes F, Barosi G, Vannucchi AM, Cazzola M; Associazione Italiana per la Ricerca sul Cancro Gruppo Italiano Malattie Mieloproliferative Investigators. Clinical effect of driver mutations of JAK2, CALR, or MPL in primary myelofibrosis. Blood. 2014 Aug 14;124(7):1062-9. doi: 10.1182/blood-2014-05-578435. Epub 2014 Jul 1.
  • Spiegel JY, McNamara C, Kennedy JA, Panzarella T, Arruda A, Stockley T, Sukhai M, Thomas M, Bartoszko J, Ho J, Siddiq N, Maze D, Schimmer A, Schuh A, Sibai H, Yee K, Claudio J, Devlin R, Minden MD, Kamel-Reid S, Gupta V. Impact of genomic alterations on outcomes in myelofibrosis patients undergoing JAK1/2 inhibitor therapy. Blood Adv. 2017 Sep 8;1(20):1729-1738. doi: 10.1182/bloodadvances.2017009530. eCollection 2017 Sep 12.
  • Thiele J, Kvasnicka HM, Facchetti F, Franco V, van der Walt J, Orazi A. European consensus on grading bone marrow fibrosis and assessment of cellularity. Haematologica. 2005 Aug;90(8):1128-32.
  • Vannucchi AM, Kantarjian HM, Kiladjian JJ, Gotlib J, Cervantes F, Mesa RA, Sarlis NJ, Peng W, Sandor V, Gopalakrishna P, Hmissi A, Stalbovskaya V, Gupta V, Harrison C, Verstovsek S; COMFORT Investigators. A pooled analysis of overall survival in COMFORT-I and COMFORT-II, 2 randomized phase III trials of ruxolitinib for the treatment of myelofibrosis. Haematologica. 2015 Sep;100(9):1139-45. doi: 10.3324/haematol.2014.119545. Epub 2015 Jun 11.
  • Vannucchi AM, Lasho TL, Guglielmelli P, Biamonte F, Pardanani A, Pereira A, Finke C, Score J, Gangat N, Mannarelli C, Ketterling RP, Rotunno G, Knudson RA, Susini MC, Laborde RR, Spolverini A, Pancrazzi A, Pieri L, Manfredini R, Tagliafico E, Zini R, Jones A, Zoi K, Reiter A, Duncombe A, Pietra D, Rumi E, Cervantes F, Barosi G, Cazzola M, Cross NC, Tefferi A. Mutations and prognosis in primary myelofibrosis. Leukemia. 2013 Sep;27(9):1861-9. doi: 10.1038/leu.2013.119. Epub 2013 Apr 26.
  • Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, DiPersio JF, Catalano JV, Deininger M, Miller C, Silver RT, Talpaz M, Winton EF, Harvey JH Jr, Arcasoy MO, Hexner E, Lyons RM, Paquette R, Raza A, Vaddi K, Erickson-Viitanen S, Koumenis IL, Sun W, Sandor V, Kantarjian HM. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):799-807. doi: 10.1056/NEJMoa1110557.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 18, 2019) 		620
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age >= 18 years
  • Diagnosis of primary myelofibrosis diagnosis according to the WHO 2016 classification or post-essential thrombocythemia/post-polycythemia vera myelofibrosis according to the IWG-MRT 2008 classification
  • Patients with an intermediate-1, intermediate-2, or high risk score according to the IPSS (International Prognostic Scoring System)
  • Patients treated with ruxolitinib in accordance with current indications in Italy
  • Patients eligible or ineligible to hematopoietic stem cell transplant or who have already undergone a hematopoietic stem cell transplant

Exclusion Criteria:

  • Diagnoses other than primary myelofibrosis or post-essential thrombocythemia/post-polycythemia vera myelofibrosis
  • Patients treated with ruxolitinib having a platelet count at treatment initiation <50 x10^9/L
  • Patients treated with ruxolitinib for conditions other than primary myelofibrosis or post-essential thrombocythemia/post-polycythemia vera myelofibrosis
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Margherita Maffioli, MD +39-0332-278281 margherita.maffioli@asst-settelaghi.it
Contact: Francesco Passamonti, MD +39-0332-393648 francesco.passamonti@asst-settelaghi.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03959371
Other Study ID Numbers RUXOREL-MF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Margherita Maffioli, Ospedale di Circolo - Fondazione Macchi
Study Sponsor Margherita Maffioli
Collaborators Not Provided
Investigators
Principal Investigator: Francesco Passamonti, MD Ospedale di Circolo ASST Sette Laghi, Università dell'Insubria, Varese, Italy
PRS Account Ospedale di Circolo - Fondazione Macchi
Verification Date May 2019

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