Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy.
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/13/2015 |
| Start Date: | March 2014 |
| End Date: | April 2020 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | 1-888-669-6682 |
Randomized, Open Label, Multicenter Phase IIIb Study Evaluating the Efficacy and Safety of Ruxolitinib Versus Best Available Therapy in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant (Response 2)
This trial will compare the efficacy and safety of ruxolitinib to Best Available Therapy
(BAT) in patients with polycythemia vera (PV) who are hyroxyurea (HU) resistant or
intolerant and do not have a palpable spleen.
(BAT) in patients with polycythemia vera (PV) who are hyroxyurea (HU) resistant or
intolerant and do not have a palpable spleen.
Inclusion Criteria:
- Confirmed diagnosis of PV according to the 2008 World Health Organization criteria,
Non-palpable spleen, Phlebotomy dependent, Resistant to or intolerant of hydroxyurea,
ECOG performance status of 0, 1 or 2.
Exclusion Criteria:
- Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or
viral infection requiring treatment, Active malignancy within the past 5 years,
excluding specific skin cancers, Previously received treatment with a JAK inhibitor,
Being treated with any investigational agent, Women who are pregnant or nursing.
Other inclusion/exclusion criteria apply.
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