Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ruxolitinib in Myelofibrosis Patients in Lombardy, Italy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03959371
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Margherita Maffioli, Ospedale di Circolo - Fondazione Macchi

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 *

*   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