Trials / Completed
CompletedNCT02966353
Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients.
A Multicenter Phase II, Open Label, Single Arm Study to Evaluate the Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This was a study of treatment with ruxolitinib in patients who presented with transfusion dependent or independent anemia. Starting dose was 10 mg BID. This dose was maintained for the first 12 weeks of the study and up-titrated thereafter unless the subject met criteria for dose hold or dose reduction
Detailed description
This was a study of treatment with ruxolitinib in patients who present with transfusion dependent or independent anemia at screening defined as an hemoglobin \<10 g/dL with 10 mg BID starting dose with subsequent up titrations (maximum dose 25 mg BID) depending on safety and efficacy. This dosing approach for anemic MF patients will be systematically studied in this prospective multicenter phase II open label single arm trial to determine if the levels of spleen length reduction and symptom improvement are consistent with those reported in previous clinical trials with ruxolitinib in patients with anemia and doses according to platelet counts at the moment of treatment initiation, and whether this lower starting dose and up titration approach may minimize the initial hemoglobin and platelet declines and transfusion requirements.
Conditions
- Primary Myelofibrosis
- Post-Polycythemia Vera-Myelofibrosis
- Post-Essential Thrombocythemia Myelofibrosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ruxolitinib | Ruxolitinib was supplied in 5 mg tablets to be taken orally approximately 12 hours apart (morning and night) |
Timeline
- Start date
- 2017-03-31
- Primary completion
- 2018-07-24
- Completion
- 2019-02-15
- First posted
- 2016-11-17
- Last updated
- 2020-04-30
- Results posted
- 2020-04-30
Locations
20 sites across 11 countries: Austria, Belgium, Bulgaria, Canada, Germany, Greece, Italy, Japan, Russia, Spain, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT02966353. Inclusion in this directory is not an endorsement.