Alternative Dosing Strategy of Ruxolitinib in Patients With Myelofibrosis

Conditions

• Post-Essential Thrombocythemia Myelofibrosis
• Post-Polycythemia Vera Myelofibrosis
• Primary Myelofibrosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib — DRUG
  Ruxolitinib was provided as 5 mg tablets. Dose increases were only permitted at wks 12 \& 18 for lack of efficacy. Increases were restricted to patients who didn't meet criteria for a dose hold over the prior 6 wks, had a platelet count ≥ 100 x 10\^9/L at wk 12 or ≥ 150 x 10\^9/L at wk 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length below the costal margin was reduced by less than 40% relative to Baseline. Dose increases were elective and not required. Subjects were permitted a dose increase of 5 mg BID to 15 mg BID at wk 12 and to a maximum of 20 mg BID at wk 18. The protocol required dose decreases for thrombocytopenia (platelets \<100 x 10\^9/L) or protocol-defined anemia (decline in hemoglobin of at least 2 g/dL to a level \< 8 g/dL, development of transfusion dependence, or a 50% increase in transfusion requirements for transfusion dependent subjects).

Study Details

The purpose of this study was to evaluate the effect of an alternative dosing strategy of ruxolitinib in subjects with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF) and post essential thrombocythemia-myelofibrosis (PET-MF) in order to minimize the development of anemia and thrombocytopenia.

Key Dates

Start date

Sep 30, 2011

Status verified

Mar 2019

Primary completion

Mar 31, 2013

Completion

Apr 30, 2013

Study Design

Enrollment

45 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Ruxolitinib
  Participants initially received ruxolitinib 10 mg twice a day (bid) for 24 weeks. Dose increases of 5 mg bid were possible at Weeks 12 and 18 up to a maximum dose of 20 mg bid.

Primary Outcome Measure

Mean Percentage Change From Baseline in Spleen Volume at Week 24 [ Time Frame: Baseline to Week 24 ]

Locations (21)

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