Clinical Trial: Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Are Available.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open-label, Multi-center, Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant and for Whom n

Brief Summary: The purpose of this open-label, single arm, multi-center Expanded Treatment Protocol (ETP) is to provide early access to ruxolitinib and evaluate safety information in patients with PV, who are HU resistant or intolerant and who have no other standard treatment option, nor do they qualify for another clinical study for PV.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 0 to 39 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in hematocrit [ Time Frame: Up to 39 months ]
  Change in Hct levels from Baseline to each visit where measured
• Change in spleen [ Time Frame: Up to 39 months ]
  Change in spleen length from Baseline to each visit where measured.
• Change in MPN-SAF [ Time Frame: Up to 39 months ]
  Change in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF) from baseline to each visit where measured.

Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: November 5, 2014
Date Started: November 21, 2014
Date Completion: December 31, 2017
Last Updated: May 7, 2017
Last Verified: May 2017