Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available.
Source: ClinicalTrials.gov NCT02292446 ↗No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events - All Grades |
143; 26 | — |
| SECONDARY Change From Baseline in Hematocrit Levels at All Visits |
45.26; 43.70; -1.55; 45.21; 40.73; -4.48 | — |
| SECONDARY Change From Baseline in Spleen Length |
23.92; 16.83; -7.09; 22.66; 16.26; -6.40 | — |
| SECONDARY Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) |
23.92; 16.83; -7.09; 22.66; 16.26; -6.40 | — |
Eligibility Criteria
Inclusion Criteria
•Confirmed diagnosis of PV according to the 2008 World Health Organization criteria, palpable spleen, Resistant to or intolerant of hydroxyurea, ECOG performance status of 0, 1 or 2; did not have access to a comparable or satisfactory alternative treatment
Exclusion Criteria
•Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or viral infection requiring treatment, Active malignancy within the past 5 years, except treated cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin, with no evidence for recurrence in the past 3 years., Women who were pregnant or nursing.
Data sourced from ClinicalTrials.gov (NCT02292446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.